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1. Milrinone in congenital diaphragmatic hernia – a randomized pilot trial: study protocol, review of literature and survey of current practices

Author

Satyan Lakshminrusimha, Martin Keszler, Haresh Kirpalani, Krisa Van Meurs, Patricia Chess, Namasivayam Ambalavanan, Bradley Yoder, Maria V. Fraga, Holly Hedrick, Kevin P. Lally, Leif Nelin, Michael Cotten, Jonathan Klein, Stephanie Guilford, Ashley Williams, Aasma Chaudhary, Marie Gantz, Jenna Gabrio, Dhuly Chowdhury, Kristin Zaterka-Baxter, Abhik Das, and Rosemary D. Higgins

Subjects
Oxygen, Phosphodiesterase, Pulmonary hypertension, Persistent pulmonary hypertension, Extracorporeal membrane oxygenation, Medicine
Abstract

Abstract Background Congenital diaphragmatic hernia (CDH) is commonly associated with pulmonary hypoplasia and pulmonary hypertension (PH). PH associated with CDH (CDH-PH) is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO) possibly due to right and left ventricular dysfunction. Milrinone is an intravenous inotrope and lusitrope with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PH. We developed this pilot study to determine if milrinone infusion would improve oxygenation in neonates ≥36 weeks postmenstrual age (PMA) with CDH. Methods/design Data on pulmonary vasodilator management and outcome of CDH patients was collected from 18 university NICUs affiliated with the Neonatal Research Network (NRN) from 2011 to 2012. The proposed pilot will be a masked, placebo–controlled, multicenter, randomized trial of 66 infants with CDH with an oxygenation index (OI) ≥10 or oxygen saturation index (OSI) ≥5. The primary outcome is the oxygenation response, as determined by change in OI at 24 h after initiation of study drug. As secondary outcomes, we will determine oxygenation at 48 h and 72 h post-infusion, right ventricular pressures on echocardiogram and the incidence of systemic hypotension, arrhythmias, intracranial hemorrhage, survival without extracorporeal membrane oxygenation, and chronic lung disease (oxygen need at 28 days postnatal age). Finally, we will evaluate the pulmonary and nutritional status at 4, 8 and 12 months of age using a phone questionnaire. Results Three hundred thirty-seven infants with CDH were admitted to NRN NICUs in 2011 and 2012 of which 275 were ≥36 weeks PMA and were exposed to the following pulmonary vasodilators: iNO (39%), sildenafil (17%), milrinone (17%), inhaled epoprostenol (6%), intravenous epoprostenol (3%), and intravenous PGE1 (1%). ECMO was required in 36% of patients. Survival to discharge was 71%. Discussion CDH is an orphan disease with high mortality with few randomized trials evaluating postnatal management. Intravenous milrinone is a commonly used medication in neonatal/pediatric intensive care units and is currently used in 17% of patients with CDH within the NRN. This pilot study will provide data and enable further studies evaluating pulmonary vasodilator therapy in CDH. Trial registration ClinicalTrials.gov; NCT02951130 ; registered 14 October 2016.

Published
2017
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2. Early-Life Outcomes in Relation to Social Determinants of Health for Children Born Extremely Preterm

Author

Jane E. Brumbaugh, Betty R. Vohr, Edward F. Bell, Carla M. Bann, Colm P. Travers, Elisabeth C. McGowan, Heidi M. Harmon, Waldemar A. Carlo, Andrea F. Duncan, Susan R. Hintz, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, Martin Keszler, Angelita M. Hensman, Barbara Alksninis, Carmena Bishop, Robert T. Burke, Melinda Caskey, Laurie Hoffman, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Vita Lamberson, Teresa M. Leach, Emilee Little, Bonnie E. Stephens, Elisa Vieira, Lucille St. Pierre, Suzy Ventura, Victoria E. Watson, Anna Maria Hibbs, Michele C. Walsh, Deanne E. Wilson-Costello, Nancy S. Newman, Monika Bhola, Allison H. Payne, Bonnie S. Siner, Gulgun Yalcinkaya, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Scott, Prabhu S. Parimi, Lisa Gaetano, Brenda B. Poindexter, Kurt Schibler, Suhas G. Kallapur, Edward F. Donovan, Stephanie Merhar, Cathy Grisby, Kimberly Yolton, Barbara Alexander, Traci Beiersdorfer, Kate Bridges, Tanya E. Cahill, Juanita Dudley, Estelle E. Fischer, Teresa L. Gratton, Devan Hayes, Jody Hessling, Lenora D. Jackson, Kristin Kirker, Holly L. Mincey, Greg Muthig, Sara Stacey, Jean J. Steichen, Stacey Tepe, Julia Thompson, Sandra Wuertz, C. Michael Cotten, Ronald N. Goldberg, Ricki F. Goldstein, William F. Malcolm, Deesha Mago-Shah, Patricia L. Ashley, Joanne Finkle, Kathy J. Auten, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Melody B. Lohmeyer, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Cindy Clark, Jennifer Talbert, Diane Warner, Andrea Trembath, T. Michael O'Shea, Janice Wereszczak, Stephen D. Kicklighter, Ginger Rhodes-Ryan, Donna White, Ravi M. Patel, David P. Carlton, Barbara J. Stoll, Ellen C. Hale, Yvonne C. Loggins, Ira Adams-Chapman, Ann Blackwelder, Diane I. Bottcher, Sheena L. Carter, Salathiel Kendrick-Allwood, Judith Laursen, Maureen Mulligan LaRossa, Colleen Mackie, Amy Sanders, Irma Seabrook, Gloria Smikle, Lynn C. Wineski, Rosemary D. Higgins, Andrew A. Bremer, Stephanie Wilson Archer, Gregory M. Sokol, Anna M. Dusick, Lu Ann Papile, Susan Gunn, Faithe Hamer, Dianne E. Herron, Abbey C. Hines, Carolyn Lytle, Lucy C. Miller, Heike M. Minnich, Leslie Richard, Lucy Smiley, Leslie Dawn Wilson, Jon E. Tyson, Kathleen A. Kennedy, Amir M. Khan, Andrea Duncan, Ricardo Mosquera, Emily K. Stephens, Georgia E. McDavid, Nora I. Alaniz, Elizabeth Allain, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Elizabeth Eason, Patricia W. Evans, Carmen Garcia, Charles Green, Donna Hall, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, M. Layne Lillie, Anna E. Lis, Karen Martin, Sara C. Martin, Carrie M. Mason, Shannon McKee, Brenda H. Morris, Kimberly Rennie, Shawna Rodgers, Saba Khan Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Jonathan L. Slaughter, Keith O. Yeates, Sarah Keim, Nathalie L. Maitre, Christopher J. Timan, Patricia Luzader, Erna Clark, Christine A. Fortney, Julie Gutentag, Courtney Park, Julie Shadd, Margaret Sullivan, Melanie Stein, Mary Ann Nelin, Julia Newton, Kristi Small, Stephanie Burkhardt, Jessica Purnell, Lindsay Pietruszewski, Katelyn Levengood, Nancy Batterson, Pamela Morehead, Helen Carey, Lina Yoseff-Salameh, Rox Ann Sullivan, Cole Hague, Jennifer Grothause, Erin Fearns, Aubrey Fowler, Jennifer Notestine, Jill Tonneman, Krystal Hay, Michelle Chao, Kyrstin Warnimont, Laura Marzec, Bethany Miller, Demi R. Beckford, Hallie Baugher, Brittany DeSantis, Cory Hanlon, Jacqueline McCool, Abhik Das, Marie G. Gantz, Dennis Wallace, Margaret M. Crawford, Jenna Gabrio, David Leblond, Jamie E. Newman, Carolyn M. Petrie Huitema, Jeanette O'Donnell Auman, W. Kenneth Poole, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, Valerie Y. Chock, David K. Stevenson, Marian M. Adams, M. Bethany Ball, Barbara Bentley, Elizabeth Bruno, Alexis S. Davis, Maria Elena DeAnda, Anne M. DeBattista, Lynne C. Huffman, Magdy Ismael, Jean G. Kohn, Casey Krueger, Janice Lowe, Ryan E. Lucash, Andrew W. Palmquist, Jessica Patel, Melinda S. Proud, Elizabeth N. Reichert, Nicholas H. St. John, Dharshi Sivakumar, Heather L. Taylor, Natalie Wager, R. Jordan Williams, Hali Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Anne Furey, Ellen Nylen, Paige T. Church, Cecelia E. Sibley, Ana K. Brussa, Namasivayam Ambalavanan, Myriam Peralta-Carcelen, Kathleen G. Nelson, Kirstin J. Bailey, Fred J. Biasini, Stephanie A. Chopko, Monica V. Collins, Shirley S. Cosby, Kristen C. Johnston, Mary Beth Moses, Cryshelle S. Patterson, Vivien A. Phillips, Julie Preskitt, Richard V. Rector, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Tarah T. Colaizy, John A. Widness, Michael J. Acarregui, Karen J. Johnson, Diane L. Eastman, Claire A. Goeke, Mendi L. Schmelzel, Jacky R. Walker, Michelle L. Baack, Laurie A. Hogden, Megan Broadbent, Chelsey Elenkiwich, Megan M. Henning, Sarah Van Muyden, Dan L. Ellsbury, Donia B. Campbell, Tracy L. Tud, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Sylvia Fajardo-Hiriart, Arielle Rigaud, Maria Calejo, Silvia M. Frade Eguaras, Michelle Harwood Berkowits, Andrea Garcia, Helina Pierre, Alexandra Stoerger, Kristi L. Watterberg, Janell Fuller, Robin K. Ohls, Sandra Sundquist Beauman, Conra Backstrom Lacy, Mary Hanson, Carol Hartenberger, Elizabeth Kuan, Jean R. Lowe, Rebecca A. Thomson, Sara B. DeMauro, Eric C. Eichenwald, Barbara Schmidt, Haresh Kirpalani, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Christine Catts, Noah Cook, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Sarvin Ghavam, Hallam Hurt, Jonathan Snyder, Saritha Vangala, Kristina Ziolkowski, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Gary J. Myers, Michelle Andrews-Hartley, Julie Babish Johnson, Kyle Binion, Melissa Bowman, Elizabeth Boylin, Erica Burnell, Kelly R. Coleman, Cait Fallone, Osman Farooq, Julianne Hunn, Diane Hust, Rosemary L. Jensen, Rachel Jones, Jennifer Kachelmeyer, Emily Kushner, Deanna Maffett, Kimberly G. McKee, Joan Merzbach, Constance Orme, Diane Prinzing, Linda J. Reubens, Daisy Rochez, Mary Rowan, Premini Sabaratnam, Ann Marie Scorsone, Holly I.M. Wadkins, Kelley Yost, Lauren Zwetsch, Satyan Lakshminrusimha, Anne Marie Reynolds, Michael G. Sacilowski, Stephanie Guilford, Emily Li, Ashley Williams, William A. Zorn, Myra H. Wyckoff, Luc P. Brion, Walid A. Salhab, Charles R. Rosenfeld, Roy J. Heyne, Diana M. Vasil, Sally S. Adams, Lijun Chen, Maria M. De Leon, Francis Eubanks, Alicia Guzman, Gaynelle Hensley, Elizabeth T. Heyne, Lizette E. Lee, Melissa H. Leps, Linda A. Madden, E. Rebecca McDougald, Nancy A. Miller, Janet S. Morgan, Lara Pavageau, Pollieanna Sepulveda, Kristine Tolentino-Plata, Cathy Twell Boatman, Azucena Vera, Jillian Waterbury, Bradley A. Yoder, Mariana Baserga, Roger G. Faix, Sarah Winter, Stephen D. Minton, Mark J. Sheffield, Carrie A. Rau, Shawna Baker, Karie Bird, Jill Burnett, Susan Christensen, Laura Cole-Bledsoe, Brandy Davis, Jennifer O. Elmont, Jennifer J. Jensen, Manndi C. Loertscher, Jamie Jordan, Trisha Marchant, Earl Maxson, Kandace M. McGrath, Karen A. Osborne, D. Melody Parry, Brixen A. Reich, Susan T. Schaefer, Cynthia Spencer, Michael Steffen, Katherine Tice, Kimberlee Weaver-Lewis, Kathryn D. Woodbury, Karen Zanetti, Robert G. Dillard, Lisa K. Washburn, Barbara G. Jackson, Nancy Peters, Korinne Chiu, Deborah Evans Allred, Donald J. Goldstein, Raquel Halfond, Carroll Peterson, Ellen L. Waldrep, Cherrie D. Welch, Melissa Whalen Morris, Gail Wiley Hounshell, Seetha Shankaran, Beena G. Sood, Girija Natarajan, Athina Pappas, Katherine Abramczyk, Prashant Agarwal, Monika Bajaj, Rebecca Bara, Elizabeth Billian, Sanjay Chawla, Kirsten Childs, Lilia C. De Jesus, Debra Driscoll, Melissa February, Laura A. Goldston, Mary E. Johnson, Geraldine Muran, Bogdan Panaitescu, Jeannette E. Prentiss, Diane White, Eunice Woldt, John Barks, Stephanie A. Wiggins, Mary K. Christensen, Martha D. Carlson, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, Joanne Williams, and Elaine Romano

Subjects
Pediatrics, Perinatology and Child Health
Published
2023
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3. Behavior Profiles at 2 Years for Children Born Extremely Preterm with Bronchopulmonary Dysplasia

Author

Jane E. Brumbaugh, Edward F. Bell, Scott F. Grey, Sara B. DeMauro, Betty R. Vohr, Heidi M. Harmon, Carla M. Bann, Matthew A. Rysavy, J. Wells Logan, Tarah T. Colaizy, Myriam A. Peralta-Carcelen, Elisabeth C. McGowan, Andrea F. Duncan, Barbara J. Stoll, Abhik Das, Susan R. Hintz, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, Martin Keszler, Angelita M. Hensman, Elisa Vieira, Emilee Little, Robert T. Burke, Bonnie E. Stephens, Barbara Alksninis, Carmena Bishop, Mary L. Keszler, Teresa M. Leach, Victoria E. Watson, Andrea M. Knoll, Michele C. Walsh, Avroy A. Fanaroff, Nancy S. Newman, Deanne E. Wilson-Costello, Allison Payne, Monika Bhola, Gulgun Yalcinkaya, Bonnie S. Siner, Harriet G. Friedman, Elizabeth Roth, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Brenda B. Poindexter, Stephanie Merhar, Kimberly Yolton, Teresa L. Gratton, Cathy Grisby, Kristin Kirker, Sandra Wuertz, David P. Carlton, Ira Adams-Chapman, Ellen C. Hale, Yvonne C. Loggins, Diane I. Bottcher, Colleen Mackie, Sheena L. Carter, Maureen Mulligan LaRossa, Lynn C. Wineski, Gloria V. Smikle, Angela Leon-Hernandez, Salathiel Kendrick-Allwood, C. Michael Cotten, Ronald N. Goldberg, Ricki F. Goldstein, William F. Malcolm, Patricia L. Ashley, Joanne Finkle, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Diane Warner, Janice Wereszczak, Stephen D. Kicklighter, Ginger Rhodes-Ryan, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Lu Ann Papile, Abbey C. Hines, Dianne E. Herron, Susan Gunn, Lucy Smiley, Kathleen A. Kennedy, Jon E. Tyson, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Patricia W. Evans, Carmen Garcia, Margarita Jiminez, Janice John, Patrick M. Jones, M. Layne Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shawna Rodgers, Saba Khan Siddiki, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Dennis Wallace, Marie G. Gantz, Jamie E. Newman, Jeanette O'Donnell Auman, Margaret Crawford, Jenna Gabrio, David Leblond, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, Valerie Y. Chock, David K. Stevenson, Marian M. Adams, M. Bethany Ball, Barbara Bentley, Maria Elena DeAnda, Anne M. Debattista, Beth Earhart, Lynne C. Huffman, Magdy Ismael, Casey E. Krueger, Andrew W. Palmquist, Melinda S. Proud, Elizabeth N. Reichert, Meera N. Sankar, Nicholas H. St. John, Heather L. Taylor, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Ellen Nylen, Anne Furey, Cecelia E. Sibley, Ana K. Brussa, Waldemar A. Carlo, Namasivayam Ambalavanan, Kirstin J. Bailey, Fred J. Biasini, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Richard V. Rector, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Radmila West, Michelle L. Baack, Dan L. Ellsbury, Laurie A. Hogden, Jonathan M. Klein, John M. Dagle, Karen J. Johnson, Tracy L. Tud, Chelsey Elenkiwich, Megan M. Henning, Megan Broadbent, Mendi L. Schmelzel, Jacky R. Walker, Claire A. Goeke, Kristi L. Watterberg, Robin K. Ohls, Conra Backstrom Lacy, Sandra Brown, Janell Fuller, Carol Hartenberger, Jean R. Lowe, Sandra Sundquist Beauman, Mary Ruffner Hanson, Tara Dupont, Elizabeth Kuan, Barbara Schmidt, Haresh Kirpalani, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl T. D'Angio, Ronnie Guillet, Gary J. Myers, Satyan Lakshminrusimha, Anne Marie Reynolds, Michelle E. Hartley-McAndrew, Holly I.M. Wadkins, Michael G. Sacilowski, Linda J. Reubens, Rosemary L. Jensen, Joan Merzbach, William Zorn, Osman Farooq, Deanna Maffett, Ashley Williams, Julianne Hunn, Stephanie Guilford, Kelley Yost, Mary Rowan, Diane M. Prinzing, Karen Wynn, Cait Fallone, Ann Marie Scorsone, Myra H. Wyckoff, Luc P. Brion, Roy J. Heyne, Diana M. Vasil, Sally S. Adams, Lijun Chen, Maria M. De Leon, Frances Eubanks, Alicia Guzman, Elizabeth T. Heyne, Linda A. Madden, Nancy A. Miller, Lizette E. Lee, Lara Pavageau, Pollieanna Sepulveda, Cathy Twell Boatman, Roger G. Faix, Bradley A. Yoder, Mariana Baserga, Karen A. Osborne, Shawna Baker, Karie Bird, Jill Burnett, Susan Christensen, Brandy Davis, Jennifer O. Elmont, Jennifer J. Jensen, Manndi C. Loertscher, Trisha Marchant, Earl Maxson, Stephen D. Minton, D. Melody Parry, Carrie A. Rau, Susan T. Schaefer, Mark J. Sheffield, Cynthia Spencer, Mike Steffen, Kimberlee Weaver-Lewis, Sarah Winter, Kathryn D. Woodbury, Karen Zanetti, Seetha Shankaran, Sanjay Chawla, Beena G. Sood, Athina Pappas, Girija Natarajan, Monika Bajaj, Rebecca Bara, Mary E. Johnson, Laura Goldston, Stephanie A. Wiggins, Mary K. Christensen, Martha Carlson, John Barks, Diane F. White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, and Elaine Romano

Subjects
Male, Pediatrics, medicine.medical_specialty, CBCL, behavioral disciplines and activities, Language Development, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Cognition, 030225 pediatrics, mental disorders, Medicine, Humans, 030212 general & internal medicine, Prospective Studies, Child Behavior Checklist, Motor skill, Bronchopulmonary Dysplasia, Problem Behavior, business.industry, Confounding, Postmenstrual Age, Infant, Newborn, medicine.disease, Bronchopulmonary dysplasia, Motor Skills, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Infant Behavior, Gestation, Female, business
Abstract

To characterize behavior of 2-year-old children based on the severity of bronchopulmonary dysplasia (BPD).We studied children born at 22-26 weeks of gestation and assessed at 22-26 months of corrected age with the Child Behavior Checklist (CBCL). BPD was classified by the level of respiratory support at 36 weeks of postmenstrual age. CBCL syndrome scales were the primary outcomes. The relationship between BPD grade and behavior was evaluated, adjusting for perinatal confounders. Mediation analysis was performed to evaluate whether cognitive, language, or motor skills mediated the effect of BPD grade on behavior.Of 2310 children, 1208 (52%) had no BPD, 806 (35%) had grade 1 BPD, 177 (8%) had grade 2 BPD, and 119 (5%) had grade 3 BPD. Withdrawn behavior (P .001) and pervasive developmental problems (P .001) increased with worsening BPD grade. Sleep problems (P = .008) and aggressive behavior (P = .023) decreased with worsening BPD grade. Children with grade 3 BPD scored 2 points worse for withdrawn behavior and pervasive developmental problems and 2 points better for externalizing problems, sleep problems, and aggressive behavior than children without BPD. Cognitive, language, and motor skills mediated the effect of BPD grade on the attention problems, emotionally reactive, somatic complaints, and withdrawn CBCL syndrome scales (P values .05).BPD grade was associated with increased risk of withdrawn behavior and pervasive developmental problems but with decreased risk of sleep problems and aggressive behavior. The relationship between BPD and behavior is complex. Cognitive, language, and motor skills mediate the effects of BPD grade on some problem behaviors.

Published
2019

4. Umbilical Cord Milking vs Delayed Cord Clamping and Associations with In-Hospital Outcomes among Extremely Premature Infants

Author

Jennifer O. Elmont, Holly I.M. Wadkins, M. Bethany Ball, Michele C. Walsh, Satyan Lakshminrusimha, Susan T. Schaefer, Toni Mancini, Melody Parry, Haresh Kirpalani, Jon E. Tyson, Gennie Bose, Namasivayam Ambalavanan, Megan M. Henning, Ann Marie Scorsone, Sanjay Chawla, Marie G. Gantz, Carl L. Bose, Seetha Shankaran, Kimberlee Weaver-Lewis, Diane I. Bottcher, John D.E. Barks, Rosemary D. Higgins, Leif D. Nelin, Kathryn D. Woodbury, Karen J. Johnson, Jennifer Donato, Stephanie Wilson Archer, Dennis Wallace, David Leblond, Tracy L. Tud, Chelsey Elenkiwich, Stephen D. Minton, Prabhu S. Parimi, Sandra Sundquist Beauman, Meena Garg, Andrew A. Bremer, Constance Orme, Anna Maria Hibbs, Mary Hanson, Joanne Finkle, Pablo J. Sánchez, Michael G. Sacilowski, Courtney Park, Laurie A. Hogden, Elizabeth Kuan, Diane F. White, Mendi L. Schmelzel, Deanna Maffett, Kathleen A. Kennedy, Sarvin Ghavam, Brandy Davis, Edward F. Bell, Martin Keszler, David P. Carlton, Emily Li, Jacky R. Walker, Elizabeth N. Reichert, Sharon L. Wright, Claire A. Goeke, Elizabeth Eason, Tara McNair, Sara B. DeMauro, Brenda B. Poindexter, Colleen Mackie, Eugenia K. Pallotto, Rachel Geller, Yvonne Loggins, Carol Hartenberger, Daisy Rochez, Waldemar A. Carlo, Frances Eubanks, Hallie Baugher, Barry Eggleston, Diane Prinzing, Teresa Chanlaw, Kandace McGrath, Carrie A. Rau, Barbara Schmidt, Stephanie Guilford, Kristin Kirker, Melinda S. Proud, Kristin M. Zaterka-Baxter, Ginger Rhodes-Ryan, Premini Sabaratnam, Georgia E. McDavid, Pollieanna Sepulvida, Cathy Grisby, Ronnie Guillet, Soraya Abbasi, Gregory M. Sokol, Mary Rowan, Abbot R. Laptook, Patricia Luzader, Myra H. Wyckoff, Luc P. Brion, Melanie Stein, Bogdan Panaitescu, Sara C. Handley, Karen Martin, Carl T. D'Angio, William E. Truog, Elisa Vieira, Kristi L. Watterberg, Allison Knutson, Cheri Gauldin, Manndi C. Loertscher, Rachel A. Jones, Jacqueline McCool, Lisa Gaetano, Bradley A. Yoder, Monica V. Collins, Ronald N. Goldberg, Michelle L. Baack, Julie C. Shadd, John M. Dagle, Mariana Baserga, Jill Burnett, Anne Marie Reynolds, Sudarshan R. Jadcherla, Emily K. Stephens, Anne Holmes, Earl Maxson, Ravi Mangal Patel, Kimberley A. Fisher, Jonathan Snyder, Rosemary L. Jensen, Jeanette O'Donnell Auman, Kirsten Childs, Stephanie L. Merhar, Angelita M. Hensman, Neha Kumbhat, Jane E. Brumbaugh, R. Jordan Williams, Eric C. Eichenwald, Maria M. DeLeon, Carla Bann, Krisa P. Van Meurs, Mark J. Sheffield, Trisha Marchant, Christine Catts, Robin K. Ohls, Claudia Pedrozza, Amir M. Khan, Conra Backstrom Lacy, Shirley S. Cosby, C. Michael Cotten, Aasma S. Chaudhary, Diana M. Vasil, Donna Hall, Janice Bernhardt, Alexis S. Davis, Kurt Schibler, Valerie Y. Chock, Erna Clark, Kyle Binion, Jonathan M. Klein, Dan L. Ellsbury, Richard A. Polin, Janell Fuller, Abhik Das, Julie Gutentag, Susan Christensen, Dianne E. Herron, Jenna Gabrio, Megan Broadbent, Lucille St. Pierre, Donna White, Cindy Clark, Elizabeth E. Foglia, Matthew M. Laughon, Stephen D. Kicklighter, Tarah T. Colaizy, David K. Stevenson, Girija Natarajan, and Uday Devaskar

Subjects
Male, medicine.medical_specialty, Gestational Age, Umbilical cord, Article, Umbilical Cord, Milking, 03 medical and health sciences, 0302 clinical medicine, Primary outcome, 030225 pediatrics, medicine, Humans, Hospital Mortality, 030212 general & internal medicine, Cerebral Intraventricular Hemorrhage, Retrospective Studies, Extremely premature, Obstetrics, business.industry, Infant, Newborn, Retrospective cohort study, medicine.disease, Constriction, medicine.anatomical_structure, Intraventricular hemorrhage, Hospital outcomes, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Female, Cord clamping, business
Abstract

OBJECTIVE: To compare in-hospital outcomes after umbilical cord milking versus delayed cord clamping among infants

Published
2021
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5. Weaning of Moderately Preterm Infants from the Incubator to the Crib: A Randomized Clinical Trial

Author

Seetha Shankaran, Edward F. Bell, Abbot R. Laptook, Shampa Saha, Nancy S. Newman, S. Nadya J. Kazzi, John Barks, Barbara J. Stoll, Rebecca Bara, Jenna Gabrio, Kirsten Childs, Abhik Das, Rosemary D. Higgins, Waldemar A. Carlo, Pablo J. Sánchez, David P. Carlton, Lara Pavageau, William F. Malcolm, Carl T. D'Angio, Robin K. Ohls, Brenda B. Poindexter, Gregory M. Sokol, Krisa P. Van Meurs, Tarah T. Colaizy, Ayman Khmour, Karen M. Puopolo, Meena Garg, Michele C. Walsh, Richard A. Polin, Martin Keszler, Angelita M. Hensman, Elisa Vieira, Anna Marie Hibbs, Bonnie S. Siner, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Kurt Schibler, Suhas G. Kallapur, Cathy Grisby, Barbara Alexander, Estelle E. Fischer, Lenora Jackson, Kristin Kirker, Jennifer Jennings, Sandra Wuertz, Greg Muthig, C. Michael Cotten, Ronald N. Goldberg, Theresa Roach, Joanne Finkle, Kimberley A. Fisher, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Cindy Clark, Stephen D. Kicklighter, Ginger Rhodes-Ryan, Ellen C. Hale, Yvonne Loggins, Diane I. Bottcher, Stephanie Wilson Archer, Heidi Harmon, Dianne E. Herron, Shirley I. Wright-Coltart, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Julie Gutentag, Courtney Park, Julie C. Shadd, Margaret Sullivan, Jennifer L. Grothause, Melanie Stein, Erna Clark, Rox Ann Sullivan, Dennis Wallace, Kristin M. Zaterka-Baxter, Margaret Crawford, Jeanette O'Donnell Auman, David K. Stevenson, Lou Ann Herfert, M. Bethany Ball, Gabrielle T. Goodlin, Melinda S. Proud, R. Jordan Williams, Namasivayam Ambalavanan, Monica V. Collins, Shirley S. Cosby, Teresa Chanlaw, Rachel Geller, Dan L. Ellsbury, Jane E. Brumbaugh, Karen J. Johnson, Donia B. Campbell, Jacky R. Walker, Kristi Watterberg, Conra Backstrom Lacy, Sandy Sundquist Beauman, Carol Hartenberger, Haresh Kirpalani, Eric C. Eichenwald, Sara B. DeMauro, Noah Cook, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara Cucinotta, Satyan Lakshminrusimha, Ronnie Guillet, Ann Marie Scorsone, Julianne Hunn, Rosemary Jensen, Holly I.M. Wadkins, Stephanie Guilford, Ashley Williams, Myra Wyckoff, Luc P. Brion, Diana M. Vasil, Lijun Chen, Lizette E. Torres, Athina Pappas, Bogdan Panaitescu, Shelley Handel, Diane F. White, Mary Christensen, and Stephanie A. Wiggins

Subjects
Male, Pediatrics, Incubators, Infant, and Human Development Neonatal Research Network, Reproductive health and childbirth, Low Birth Weight and Health of the Newborn, Infant Equipment, law.invention, incubator, Incubators, 0302 clinical medicine, Randomized controlled trial, law, Neonatal, Infant Mortality, 030212 general & internal medicine, Pediatric, Obstetrics, weaning, Incubator, General Medicine, Patient Discharge, Intensive Care Units, Gestation, Female, Patient Safety, medicine.symptom, Infant, Premature, medicine.medical_specialty, Clinical Trials and Supportive Activities, MEDLINE, Weaning, Article, Child health, Paediatrics and Reproductive Medicine, moderately preterm infants, 03 medical and health sciences, Preterm, Clinical Research, 030225 pediatrics, Intensive Care Units, Neonatal, medicine, Humans, Trial registration, Adverse effect, Premature, business.industry, Body Weight, Infant, Newborn, Infant, temperature, Human Movement and Sports Sciences, Perinatal Period - Conditions Originating in Perinatal Period, Length of Stay, Newborn, Eunice Kennedy Shriver National Institute of Child Health, Good Health and Well Being, randomized controlled trial, Pediatrics, Perinatology and Child Health, business, Weight gain
Abstract

ObjectiveTo assess whether length of hospital stay is decreased among moderately preterm infants weaned from incubator to crib at a lower vs higher weight.Study designThis trial was conducted in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants with gestational ages 29-33 weeks, birthweight

Published
2018

6. Antecedents and Outcomes of Abnormal Cranial Imaging in Moderately Preterm Infants

Author

Namasivayam Ambalavanan, Sarah McGregor, Teresa Chanlaw, Abbot R. Laptook, Martin Keszler, Shampa Saha, Sudarshan R. Jadcherla, Stephanie A. Wiggins, Stephanie Guilford, Waldemar A. Carlo, Greg Muthig, Karen Martin, Michele C. Walsh, Patricia Luzader, Nehal A. Parikh, Nancy S. Newman, David P. Carlton, Carl T. D'Angio, Eugenia K. Pallotto, Rachel Geller, Richard A. Polin, Anne Holmes, Satyan Lakshminrusimha, Dennis Wallace, Holly I.M. Wadkins, Anna Marie Hibbs, Carl L. Bose, Jeanette O'Donnell Auman, Cindy Clark, Haresh Kirpalani, Girija Natarajan, Jodi A. Ulloa, Jon E. Tyson, Julie Arldt-McAlister, Barbara J. Stoll, Edward F. Bell, Ronald N. Goldberg, Yvonne Loggins, Marliese Dion Nist, Lenora Jackson, Jacky R. Walker, Jane E. Brumbaugh, Cheri Gauldin, John D.E. Barks, Rosemary L. Jensen, Donia B. Campbell, Rosemary D. Higgins, Bonnie S. Siner, Monica V. Collins, Toni Mancini, Ann Marie Scorsone, Janice Bernhardt, Seetha Shankaran, Kristin M. Zaterka-Baxter, Jennifer Fuller, Lizette E. Torres, Kathy Johnson, Karen J. Johnson, Luc P. Brion, Margaret M. Crawford, Leif D. Nelin, Diane I. Bottcher, Julianne Hunn, Carol Hartenberger, Carmen Garcia, M. Bethany Ball, Shirley S. Cosby, Marissa E. Jones, Matthew M. Laughon, Diane F. White, Barbara Alexander, Pablo J. Sánchez, Meena Garg, Uday Devaskar, Estelle E. Fischer, Ellen C. Hale, Sharon L. Wright, Athina Pappas, Conra Backstrom Lacy, Mary Christensen, Tarah T. Colaizy, David K. Stevenson, Lijun Chen, Shelley Handel, Rebecca Bara, Kristin Kirker, Melinda S. Proud, Dan L. Ellsbury, Betty R. Vohr, Sara B. DeMauro, Cathy Grisby, Robin K. Ohls, Tara Wolfe, Diana M. Vasil, Dara M. Cucinotta, Kimberley A. Fisher, Soraya Abbasi, Stephanie Wilson Archer, Joanne Finkle, Myra H. Wyckoff, Elisa Vieira, Suhas G. Kallapur, Dianne E. Herron, Jenna Gabrio, Howard W. Kilbride, Jennifer Jennings, Abhik Das, Julie Gutentag, Sandy Sundquist Beauman, Greg Sokol, Ashley Williams, Angelita M. Hensman, Krisa P. Van Meurs, Aasma S. Chaudhary, Georgia E. McDavid, Elizabeth Rodgers, and Sandra Wuertz

Subjects
Adult, medicine.medical_specialty, Leukomalacia, Periventricular, Resuscitation, Gestational Age, Antenatal steroid, Article, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Neonatal Screening, Pregnancy, Risk Factors, 030225 pediatrics, medicine, Humans, Prospective Studies, Registries, Obstetrics, business.industry, Cesarean Section, Infant, Newborn, Gestational age, Brain, Infant, Stepwise regression, medicine.disease, Cystic Periventricular Leukomalacia, Chorioamnionitis, Logistic Models, Pediatrics, Perinatology and Child Health, Infant, Small for Gestational Age, Gestation, Small for gestational age, Female, business, Intracranial Hemorrhages, 030217 neurology & neurosurgery, Neonatal resuscitation, Infant, Premature, Ventriculomegaly, Hydrocephalus
Abstract

OBJECTIVES: To describe the frequency and findings of cranial imaging in moderately preterm (MPT) infants (born at 29 0/7–33 6/7 weeks of gestation) across centers, and to examine the association between abnormal imaging and clinical characteristics. STUDY DESIGN: We used data from the Neonatal Research Network MPT Registry, including the most severe early (≤28 days) and late (>28 days) cranial imaging. Stepwise logistic regression and CART analysis were performed after adjustment for gestational age (GA), antenatal steroids and center. RESULTS: Among 7,021 infants, 4,184 (60%) underwent cranial imaging. These infants had lower GAs and birth weights and higher rates of birth weight small-for-gestation, outborn birth, cesarean delivery; neonatal resuscitation and treatment with surfactant, compared with those without imaging (P < .0001). Imaging abnormalities noted in 15% of the infants included any intracranial hemorrhage (13.2%), grades 3–4 intracranial hemorrhage (1.7%), cystic periventricular leukomalacia (2.6%) and ventriculomegaly (6.6%). Histological chorioamnionitis [OR 1.47; 95% C.I.:1.19–1.83], GA [0.95; 95% C.I.: 0.94–0.97], antenatal steroids [OR 0.55; 95% C.I.: 0.41–0.74] and cesarean delivery [OR 0.66; 95% C.I.: 0.53–0.81] were associated with abnormal imaging. The center with the highest rate of cranial imaging, compared with the lowest, had a higher risk of abnormal imaging [OR 2.08; 95% CI: 1.10–3.92]. On the CART model, cesarean delivery, center, antenatal steroids and chorioamnionitis, in that order, predicted abnormal imaging. CONCLUSIONS: Among the 60% of MPT infants with cranial imaging, 15% had intracranial hemorrhage, cystic periventricular leukomalacia or late ventriculomegaly. Further correlation of imaging and long-term neurodevelopmental outcomes in MPT infants is needed.

Published
2017

7. Admission Temperature and Associated Mortality and Morbidity among Moderately and Extremely Preterm Infants

Author

Abbot R. Laptook, Edward F. Bell, Seetha Shankaran, Nansi S. Boghossian, Myra H. Wyckoff, Sarah Kandefer, Michele Walsh, Shampa Saha, Rosemary Higgins, Richard A. Polin, Martin Keszler, Betty R. Vohr, Angelita M. Hensman, Elisa Vieira, Emilee Little, Avroy A. Fanaroff, Anna Marie Hibbs, Nancy S. Newman, Bonnie S. Siner, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Kurt Schibler, Suhas G. Kallapur, Cathy Grisby, Barbara Alexander, Estelle E. Fischer, Lenora Jackson, Kristin Kirker, Jennifer Jennings, Sandra Wuertz, Greg Muthig, Edward F. Donovan, Jody Hessling, Marcia Worley Mersmann, Holly L. Mincey, C. Michael Cotten, Ronald N. Goldberg, Joanne Finkle, Kimberley A. Fisher, Kathy J. Auten, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Cindy Clark, Barbara J. Stoll, David P. Carlton, Ellen C. Hale, Yvonne Loggins, Diane I. Bottcher, Stephanie Wilson Archer, Linda L. Wright, Elizabeth M. McClure, Brenda B. Poindexter, Gregory M. Sokol, Dianne E. Herron, James A. Lemons, Diana D. Appel, Lucy C. Miller, Pablo J. Sanchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Nehal A. Parikh, Marliese Dion Nist, Jennifer Fuller, Julie Gutentag, Marissa E. Jones, Sarah McGregor, Elizabeth Rodgers, Jodi A. Ulloa, Tara Wolfe, Abhik Das, Dennis Wallace, W. Kenneth Poole, Kristin M. Zaterka-Baxter, Margaret Crawford, Jenna Gabrio, Jeanette O'Donnell Auman, Carolyn Petrie Huitema, Betty K. Hastings, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Melinda S. Proud, Waldemar A. Carlo, Namasivayam Ambalavanan, Monica V. Collins, Shirley S. Cosby, Uday Devaskar, Meena Garg, Teresa Chanlaw, Rachel Geller, Tarah T. Colaizy, Dan L. Ellsbury, Jane E. Brumbaugh, Karen J. Johnson, Donia B. Campbell, Jacky R. Walker, Kristi L. Watterberg, Robin K. Ohls, Conra Backstrom Lacy, Sandra Sundquist Beauman, Carol Hartenberger, Barbara Schmidt, Haresh Kirpalani, Noah Cook, Sara B. DeMauro, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara Cucinotta, Carl T. D'Angio, Ronnie Guillet, Satyan Lakshminrusimha, Dale L. Phelps, Ann Marie Reynolds, Julianne Hunn, Rosemary Jensen, Holly I.M. Wadkins, Stephanie Guilford, Ashley Williams, Michael Sacilowski, Linda Reubens, Erica Burnell, Mary Rowan, Karen Wynn, Deanna Maffett, Luc P. Brion, Diana M. Vasil, Lijun Chen, Lizette E. Torres, Walid A. Salhab, Susie Madison, Gay Hensley, Nancy A. Miller, Alicia Guzman, Kathleen A. Kennedy, Jon E. Tyson, Julie Arldt-McAlister, Carmen Garcia, Karen Martin, Georgia E. McDavid, Sharon L. Wright, Esther G. Akpa, Patty A. Cluff, Anna E. Lis, Claudia I. Franco, Athina Pappas, John Barks, Rebecca Bara, Shelley Handel, Geraldine Muran, Diane F. White, Mary Christensen, and Stephanie A. Wiggins

Subjects
Male, Pediatrics, medicine.medical_specialty, Fever, Hospital mortality, Hypothermia, Infant, Premature, Diseases, Logistic regression, Child health, Article, Body Temperature, 03 medical and health sciences, 0302 clinical medicine, Patient Admission, Risk Factors, 030225 pediatrics, Intensive Care Units, Neonatal, Medicine, Humans, 030212 general & internal medicine, Hospital Mortality, business.industry, Extremely preterm, Infant, Newborn, Infant newborn, United States, Logistic Models, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Female, business
Abstract

To evaluate the temperature distribution among moderately preterm (MPT, 29-33 weeks) and extremely preterm (EPT,29 weeks) infants upon neonatal intensive care unit (NICU) admission in 2012-2013, the change in admission temperature distribution for EPT infants between 2002-2003 and 2012-2013, and associations between admission temperature and mortality and morbidity for both MPT and EPT infants.Prospectively collected data from 18 centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network were used to examine NICU admission temperature of inborn MPT and EPT infants. Associations between admission temperature and mortality and morbidity were determined by multivariable logistic regression. EPT infants from 2002-2003 and 2012-2013 were compared.MPT and EPT cohorts consisted of 5818 and 3213 infants, respectively. The distribution of admission temperatures differed between the MPT vs EPT (P .01), including the percentage36.5°C (38.6% vs 40.9%), 36.5°C-37.5°C (57.3% vs 52.9%), and37.5°C (4.2% vs 6.2%). For EPT infants in 2012-2013 compared with 2002-2003, the percentage of temperatures between 36.5°C and 37.5°C more than doubled and the percentage of temperatures37.5°C more than tripled. Admission temperature was inversely associated with in-hospital mortality.Low and high admission temperatures are more frequent among EPT than MPT infants. Compared with a decade earlier, fewer EPT infants experience low admission temperatures but more have elevated temperatures. In spite of a change in distribution of NICU admission temperature, an inverse association between temperature and mortality risk persists.

Published
2017

8. Milrinone in congenital diaphragmatic hernia - a randomized pilot trial: study protocol, review of literature and survey of current practices

Author

Jenna Gabrio, Leif D. Nelin, Jonathan M. Klein, Kevin P. Lally, Krisa P. Van Meurs, Abhik Das, Stephanie Guilford, Rosemary D. Higgins, Aasma S. Chaudhary, Kristin M. Zaterka-Baxter, Haresh Kirpalani, Patricia R. Chess, Namasivayam Ambalavanan, Satyan Lakshminrusimha, Ashley Williams, Marie G. Gantz, María V. Fraga, Dhuly Chowdhury, Holly L. Hedrick, Michael Cotten, Bradley A. Yoder, and Martin Keszler

Subjects
Sildenafil, Oxygenation index, medicine.medical_treatment, Clinical Trials and Supportive Activities, lcsh:Medicine, Review, Persistent pulmonary hypertension, Pulmonary hypertension, 03 medical and health sciences, chemistry.chemical_compound, Pulmonary hypoplasia, 0302 clinical medicine, Rare Diseases, Clinical Research, 030225 pediatrics, Intensive care, Infant Mortality, Extracorporeal membrane oxygenation, Medicine, Phosphodiesterase, 030212 general & internal medicine, Lung, 2. Zero hunger, Pediatric, business.industry, lcsh:R, Congenital diaphragmatic hernia, Evaluation of treatments and therapeutic interventions, Perinatal Period - Conditions Originating in Perinatal Period, medicine.disease, 3. Good health, Oxygen, Orphan Drug, Good Health and Well Being, chemistry, Anesthesia, 6.1 Pharmaceuticals, Milrinone, business, Digestive Diseases, medicine.drug
Abstract

BackgroundCongenital diaphragmatic hernia (CDH) is commonly associated with pulmonary hypoplasia and pulmonary hypertension (PH). PH associated with CDH (CDH-PH) is frequently resistant to conventional pulmonary vasodilator therapy including inhaled nitric oxide (iNO) possibly due to right and left ventricular dysfunction. Milrinone is an intravenous inotrope and lusitrope with pulmonary vasodilator properties and has been shown anecdotally to improve oxygenation in PH. We developed this pilot study to determine if milrinone infusion would improve oxygenation in neonates ≥36weeks postmenstrual age (PMA) with CDH.Methods/designData on pulmonary vasodilator management and outcome of CDH patients was collected from 18 university NICUs affiliated with the Neonatal Research Network (NRN) from 2011 to 2012. The proposed pilot will be a masked, placebo-controlled, multicenter, randomized trial of 66 infants with CDH with an oxygenation index (OI) ≥10 or oxygen saturation index (OSI) ≥5. The primary outcome is the oxygenation response, as determined by change in OI at 24h after initiation of study drug. As secondary outcomes, we will determine oxygenation at 48h and 72h post-infusion, right ventricular pressures on echocardiogram and the incidence of systemic hypotension, arrhythmias, intracranial hemorrhage, survival without extracorporeal membrane oxygenation, and chronic lung disease (oxygen need at 28days postnatal age). Finally, we will evaluate the pulmonary and nutritional status at 4, 8 and 12months of age using a phone questionnaire.ResultsThree hundred thirty-seven infants with CDH were admitted to NRN NICUs in 2011 and 2012 of which 275 were ≥36weeks PMA and were exposed to the following pulmonary vasodilators: iNO (39%), sildenafil (17%), milrinone (17%), inhaled epoprostenol (6%), intravenous epoprostenol (3%), and intravenous PGE1 (1%). ECMO was required in 36% of patients. Survival to discharge was 71%.DiscussionCDH is an orphan disease with high mortality with few randomized trials evaluating postnatal management. Intravenous milrinone is a commonly used medication in neonatal/pediatric intensive care units and is currently used in 17% of patients with CDH within the NRN. This pilot study will provide data and enable further studies evaluating pulmonary vasodilator therapy in CDH.Trial registrationClinicalTrials.gov; NCT02951130; registered 14 October 2016.

Published
2017
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9. Tools and processes for tracking IRB approvals as a coordinating center for large multicenter clinical research networks

Author

Kristin M. Zaterka-Baxter, Jenna Gabrio, Jeanette O'Donnell Auman, Margaret M. Crawford, and Lindsay M. Parlberg

Subjects
Receipt, Engineering management, Resource (project management), Documentation, Data collection, business.industry, Informatics, Medicine, Tracking (education), business, Dissemination
Abstract

Background: Data coordinating centers (DCCs) for multicenter research networks are often responsible for tracking clinical center (CC) IRB approvals. In networks with multiple studies the volume of documentation can be challenging to manage. DCC informatics specialists and coordinators developed simple electronic tools and processes to fulfill this responsibility.Methods: Informatics specialists created a Microsoft Access database to track receipt of IRB approvals from CCs. The database monitors approval expiration dates for an unlimited number of studies and CCs and generates automated reports displaying information on all documented approvals. Coordinators formalized communication procedures for collecting approvals and disseminating information on file. The DCC established a central e-mail account to which CCs submit documentation. The DCC sends monthly e-mails notifying CCs that updated IRB reports have been posted. CCs determine what documentation must be sent to the DCC, and the DCC verifies that all submitted documentation is valid.Results: The database increased DCC efficiencies with a semiautomated mechanism and standardized procedures. New communication processes strengthened compliance with regulatory guidance and client requirements to monitor data collection with appropriate human subjects protections in place. The IRB approval-related e-mail volume sent to CCs was reduced. Automated highlighting of approvals expiring soon reduced DCC coordinator efforts and minimized potential for noncompliance.Conclusions: Although initial investment is needed, formalization of the database and processes result in resource savings throughout the organization’s tenure as a DCC. The flexible nature of access databases makes them an efficient solution for tracking IRB approvals in networks with fluid center compositions.

Published
2019
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10. Delivery Room Resuscitation and Short-Term Outcomes in Moderately Preterm Infants

Author

Carmen Garcia, Namasivayam Ambalavanan, Estelle E. Fischer, John D.E. Barks, Rosemary D. Higgins, Kristi L. Watterberg, Mary Christensen, Jeanette O'Donnell Auman, Abbot R. Laptook, Ronnie Guillet, David K. Stevenson, Lijun Chen, Dianne E. Herron, Karen Martin, Conra Backstrom Lacy, Eugenia K. Pallotto, Rachel Geller, Shirley S. Cosby, Teresa Chanlaw, C. Michael Cotten, Myra H. Wyckoff, Yvonne Loggins, Elisa Vieira, Seetha Shankaran, Patricia Luzader, Kristin M. Zaterka-Baxter, Stephanie Wilson Archer, Jenna Gabrio, Jennifer Fuller, Diane I. Bottcher, Haresh Kirpalani, Carl T. D'Angio, Joanne Finkle, Holly I.M. Wadkins, Luc P. Brion, Cindy Clark, Janice Bernhardt, Barbara J. Stoll, Brenda B. Poindexter, Howard W. Kilbride, Jennifer Jennings, Matthew M. Laughon, Suhas G. Kallapur, Meena Garg, Margaret M. Crawford, Satyan Lakshminrusimha, Pablo J. Sánchez, Jon E. Tyson, Uday Devaskar, Abhik Das, Tarah T. Colaizy, Angelita M. Hensman, Jacky R. Walker, Carol Hartenberger, Cathy Grisby, Barbara Alexander, Sarah Kandefer, Robin K. Ohls, Ronald N. Goldberg, Julie Gutentag, Shelley Handel, Kathleen A. Kennedy, Bonnie S. Siner, Sandy Sundquist Beauman, William E Truog, Sharon L. Wright, Athina Pappas, Girija Natarajan, Marliese Dion Nist, Marissa E. Jones, Jodi A. Ulloa, Kristin Kirker, Melinda S. Proud, Betty R. Vohr, Sara B. DeMauro, Nancy S. Newman, Dara M. Cucinotta, Waldemar A. Carlo, Krisa P. Van Meurs, Greg Muthig, Lizette E. Torres, Kimberley A. Fisher, Donia B. Campbell, Edward F. Bell, Lenora Jackson, Rosemary L. Jensen, Cheri Gauldin, Soraya Abbasi, Dan L. Ellsbury, Monica V. Collins, Greg Sokol, Stephanie Guilford, Ellen C. Hale, Ann Marie Scorsone, Barbara Schmidt, Kathy Johnson, Karen J. Johnson, Dennis Wallace, Julianne Hunn, M. Bethany Ball, Anne Holmes, Diane F. White, Richard A. Polin, Noah Cook, Tara Wolfe, Julie Arldt-McAlister, Sudarshan R. Jadcherla, Jane E. Brumbaugh, Shampa Saha, Ashley Williams, Diana M. Vasil, Monika Bajaj, Toni Mancini, Georgia E. McDavid, Elizabeth Rodgers, David P. Carlton, Sandra Wuertz, Rebecca Bara, Aasma S. Chaudhary, Sarah McGregor, Kurt Schibler, Anna Marie Hibbs, Michele C. Walsh, Nehal A. Parikh, Leif D. Nelin, Martin Keszler, Stephanie A. Wiggins, and Carl L. Bose

Subjects
Male, Resuscitation, medicine.medical_treatment, Article, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, 030225 pediatrics, Outcome Assessment, Health Care, Intubation, Intratracheal, Humans, Rupture of membranes, Medicine, Prospective Studies, Registries, 030212 general & internal medicine, Cardiopulmonary resuscitation, Continuous positive airway pressure, Respiratory system, Continuous Positive Airway Pressure, business.industry, Delivery Rooms, Delivery room, Infant, Newborn, Oxygen Inhalation Therapy, Gestational age, Cardiopulmonary Resuscitation, Anesthesia, Infant, Small for Gestational Age, Pediatrics, Perinatology and Child Health, Female, business, Infant, Premature, Cohort study
Abstract

Objectives To describe the frequency and extent of delivery room resuscitation and evaluate the association of delivery room resuscitation with neonatal outcomes in moderately preterm (MPT) infants. Study design This was an observational cohort study of MPT infants delivered at 290/7 to 336/7 weeks' gestational age (GA) enrolled in the Neonatal Research Network MPT registry. Infants were categorized into 5 groups based on the highest level of delivery room intervention: routine care, oxygen and/or continuous positive airway pressure, bag and mask ventilation, endotracheal intubation, and cardiopulmonary resuscitation including chest compressions and/or epinephrine use. The association of antepartum and intrapartum risk factors and discharge outcomes with the intensity of resuscitation was evaluated. Results Of 7014 included infants, 1684 (24.0%) received routine care and no additional resuscitation, 2279 (32.5%) received oxygen or continuous positive airway pressure, 1831 (26.1%) received bag and mask ventilation, 1034 (14.7%) underwent endotracheal intubation, and 186 (2.7%) received cardiopulmonary resuscitation. Among the antepartum and intrapartum factors, increasing GA, any exposure to antenatal steroids and prolonged rupture of membranes decreased the likelihood of receipt of all levels of resuscitation. Infants who were small for GA (SGA) had increased risk of delivery room resuscitation. Among the neonatal outcomes, respiratory support at 28 days, days to full oral feeds and length of stay were significantly associated with the intensity of delivery room resuscitation. Higher intensity of resuscitation was associated with increased risk of mortality. Conclusions The majority of MPT infants receive some level of delivery room resuscitation. Increased intensity of delivery room interventions was associated with prolonged respiratory and nutritional support, increased mortality, and a longer length of stay.

Published
2018
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11. Outcome of Preterm Infants with Transient Cystic Periventricular Leukomalacia on Serial Cranial Imaging Up to Term Equivalent Age

Author

Subrata Sarkar, Seetha Shankaran, John Barks, Barbara T. Do, Abbot R. Laptook, Abhik Das, Namasivayam Ambalavanan, Krisa P. Van Meurs, Edward F. Bell, Pablo J. Sanchez, Susan R. Hintz, Myra H. Wyckoff, Barbara J. Stoll, Waldemar A. Carlo, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Martin Keszler, William Oh, Betty R. Vohr, Angelita M. Hensman, Barbara Alksninis, Kristin M. Basso, Robert Burke, Melinda Caskey, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Emilee Little, Elisabeth C. McGowan, Elisa Vieira, Victoria E. Watson, Suzy Ventura, Michele C. Walsh, Avroy A. Fanaroff, Anna Marie Hibbs, Deanne E. Wilson-Costello, Nancy S. Newman, Allison H. Payne, Bonnie S. Siner, Monika Bhola, Gulgun Yalcinkaya, Harriet G. Friedman, William E. Truog, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Edward F. Donovan, Cathy Grisby, Kate Bridges, Barbara Alexander, Estelle E. Fischer, Holly L. Mincey, Jody Hessling, Teresa L. Gratton, Lenora Jackson, Kristin Kirker, Greg Muthig, Jean J. Steichen, Stacey Tepe, Marcia Worley Mersmann, Kimberly Yolton, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, Patricia L. Ashley, William F. Malcolm, Kathy J. Auten, Kimberley A. Fisher, Sandra Grimes, Kathryn E. Gustafson, Melody B. Lohmeyer, Joanne Finkle, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Gennie Bose, Diane Warner, Janice Wereszczak, David P. Carlton, Ira Adams-Chapman, Ellen C. Hale, Yvonne Loggins, Ann M. Blackwelder, Diane I. Bottcher, Colleen Mackie, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Brenda B. Poindexter, James A. Lemons, Anna M. Dusick, Lu-Ann Papile, Carolyn Lytle, Abbey C. Hines, Heike M. Minnich, Dianne E. Herron, Lucy Smiley, Susan Gunn, Leslie Dawn Wilson, Kathleen A. Kennedy, Jon E. Tyson, Georgia E. McDavid, Esther G. Akpa, Julie Arldt-McAlister, Nora I. Alaniz, Katrina Burson, Pamela J. Bradt, Susan Dieterich, Allison Dempsey, Andrea F. Duncan, Patricia W. Evans, Claudia I. Franco, Carmen Garcia, Charles Green, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, Layne M. Lillie, Anna E. Lis, Terri Major-Kincade, Karen Martin, Sara C. Martin, Brenda H. Morris, Patricia Ann Orekoya, Stacey Reddoch, Shawna Rodgers, Saba Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Laura L. Whitely, Sharon L. Wright, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Dennis Wallace, Marie G. Gantz, W. Kenneth Poole, Margaret M. Crawford, Jenna Gabrio, Betty K. Hastings, Jamie E. Newman, Jeanette O'Donnell Auman, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, David K. Stevenson, M. Bethany Ball, Marian M. Adams, Alexis S. Davis, Andrew W. Palmquist, Melinda S. Proud, Barbara Bentley, Elizabeth Bruno, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Jean G. Kohn, Casey Krueger, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Brenda L. MacKinnon, Anne Furey, Ellen Nylen, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Fred J. Biasini, Kristen C. Johnston, Kathleen G. Nelson, Cryshelle S. Patterson, Vivien A. Phillips, Sally Whitley, Uday Devaskar, Meena Garg, Isabell B. Purdy, Teresa Chanlaw, Rachel Geller, Neil N. Finer, David Kaegi, Maynard R. Rasmussen, Paul R. Wozniak, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Chris Henderson, Wade Rich, Yvonne E. Vaucher, Tarah T. Colaizy, Michael J. Acarregui, Jane E. Brumbaugh, Dan L. Ellsbury, John A. Widness, Karen J. Johnson, Donia B. Campbell, Diane L. Eastman, Nancy J. Krutzfield, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Sylvia Fajardo-Hiriart, Arielle Rigaud, Maria Calejo, Silvia M. Frade Eguaras, Michelle Harwood Berkowits, Andrea Garcia, Helina Pierre, Alexandra Stoerger, Kristi L. Watterberg, Jean R. Lowe, Tara Dupont, Janell F. Fuller, Robin K. Ohls, Conra Backstrom Lacy, Rebecca Montman, Barbara Schmidt, Haresh Kirpalani, Sara B. DeMauro, Aasma S. Chaudhary, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Noah Cook, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Satyan Lakshminrusimha, Julie Babish Johnson, Erica Burnell, Linda J. Reubens, Cassandra A. Horihan, Rosemary L. Jensen, Emily Kushner, Joan Merzbach, Gary J. Myers, Mary Rowan, Holly I.M. Wadkins, Anne Marie Scorsone, Melissa Bowman, Julianne Hunn, Stephanie Guilford, Deanna Maffett, Osman Farooq, Diane Prinzing, Anne Marie Reynolds, Michael G. Sacilowski, Ashley Williams, Karen Wynn, Kelley Yost, William Zorn, Lauren Zwetsch, Luc P. Brion, R. Sue Broyles, Roy J. Heyne, Merle Ipson, Walid A. Salhab, Charles R. Rosenfeld, Diana M. Vasil, Lijun Chen, Alicia Guzman, Gaynelle Hensley, Jackie F. Hickman, Melissa H. Leps, Susie Madison, Nancy A. Miller, Janet S. Morgan, Lara Pavageau, Sally S. Adams, Cristin Dooley, Elizabeth T. Heyne, Lizette E. Lee, Linda A. Madden, Catherine Twell Boatman, Roger G. Faix, Bradley A. Yoder, Karen A. Osborne, Cynthia Spencer, Kimberlee Weaver-Lewis, Shawna Baker, Karie Bird, Jill Burnett, Michael Steffen, Jennifer J. Jensen, Sarah Winter, Karen Zanetti, T. Michael O'Shea, Robert G. Dillard, Lisa K. Washburn, Barbara G. Jackson, Nancy J. Peters, Korinne Chiu, Deborah Evans Allred, Donald J. Goldstein, Raquel Halfond, Carroll Peterson, Ellen L. Waldrep, Cherrie D. Welch, Melissa Whalen Morris, Gail Wiley Hounshell, Athina Pappas, Rebecca Bara, Laura A. Goldston, Geraldine Muran, Girija Natarajan, Mary Christensen, Stephanie A. Wiggins, Diane White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Patricia Gettner, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Elaine Romano, Janet Taft, and Joanne Williams

Subjects
Male, congenital, hereditary, and neonatal diseases and abnormalities, Pediatrics, medicine.medical_specialty, Adverse outcomes, Developmental Disabilities, Leukomalacia, Periventricular, Gestational Age, Article, 03 medical and health sciences, Neonatal Screening, 0302 clinical medicine, Risk Factors, 030225 pediatrics, medicine, Humans, Prospective Studies, cardiovascular diseases, reproductive and urinary physiology, Ultrasonography, business.industry, Term equivalent age, Infant, Newborn, Brain, Infant, Cystic Periventricular Leukomalacia, nervous system diseases, Logistic Models, Increased risk, nervous system, Case-Control Studies, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Gestation, Female, business, 030217 neurology & neurosurgery
Abstract

OBJECTIVE: To determine the outcome of preterm infants whose cystic periventricular leukomalacia “disappeared” on serial screening cranial imaging studies. STUDY DESIGN: Infants ≤26 weeks of gestation born between 2002 and 2012 who had cranial imaging studies at least twice, the most abnormal study at

Published
2018
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12. Effect of depth and duration of cooling on deaths in the NICU among neonates with hypoxic ischemic encephalopathy: a randomized clinical trial

Author

Susan Gunn, Stephanie Guilford, Lisa Sulkowski, Shannon E. G. Hamrick, David P. Carlton, Cathy Grisby, Sara B. De Mauro, Scott A. McDonald, Amir M. Khan, Christine A. Gleason, Jeffrey L. Segar, Sandra Grimes, William E. Truog, Lenora Jackson, Conra Backstrom Lacy, Cheri Gauldin, Kimberley A. Fisher, Carmen Garcia, Jacky R. Walker, Nancy S. Newman, Brenda B. Poindexter, Nirupama Laroia, Monica V. Collins, Jonathan M. Klein, Ellen C. Hale, Jeffrey R. Parker, Emilee Little, Tracy L. Nolen, Carol K. Redmond, Sandra Sundquist Beauman, Namasivayam Ambalavanan, Toni Mancini, Richard A. Polin, Aasma S. Chaudhary, Janice Bernhardt, Athina Pappas, Alexis S. Davis, Emma Ramon, Kathleen Weingarden, Laura Sumner, Edward F. Bell, Edward G. Shepherd, Karen J. Johnson, Beena G. Sood, Holly I.M. Wadkins, Robert D. Roghair, Patrick J. Conway, Julie Arldt-McAlister, Mary E. Johnson, Kevin Dysart, Myra H. Wyckoff, Lina F. Chalak, Ann Marie Scorsone, Donia B. Campbell, Rebecca Bara, Howard W. Kilbride, Anne Marie Reynolds, Dennis Wallace, Soraya Abbasi, Satyanarayana Lakshminrusimha, Carl L. Bose, Jon E. Tyson, Kathy Johnson, Ronnie Guillet, Robert T. Burke, Sharon L. Wright, Jeanette O'Donnell Auman, Teresa Chanlaw, Glenda K. Rabe, Suhas G. Kallapur, Ashley Williams, Gail E. Besner, Elisa Vierira, Stephanie Wilson Archer, Waldemar A. Carlo, Greg Muthig, Leslie T. McKinley, Sandra Wuertz, Shirley S. Cosby, Kristin Kirker, Melinda S. Proud, Melinda Caskey, Angelita M. Hensman, Kimberly Hayes-Hart, Karen Martin, Claudia Pedroza, Eugenia K. Pallotto, Carolyn M. Petrie Huitema, Lauritz R. Meyer, Jane E. Brumbaugh, Patricia Luzader, Jamie E. Newman, Georgia E. McDavid, Joanne Finkle, Meena Garg, Carl T. D'Angio, Vipinchandra Bhavsar, Krisa P. Van Meurs, Anne Holmes, Sudarshan R. Jadcherla, Ross Sommers, John D.E. Barks, Rosemary D. Higgins, Traci E Clemons, Leslie Dawn Wilson, Michael G. Sacilowski, Karen A. Wynn, Martin Keszler, Kristi L. Watterberg, Nicole Walker, Christine A. Fortney, Stephanie A. Wiggins, Cary R. Murphy, Marian Willinger, Michael S. Caplan, Betty R. Vohr, Rachel Geller, Ronald N. Goldberg, Margaret M. Crawford, Lucy Smiley, Steven J. Weiner, Dara M. Cucinotta, Barbara Schmidt, Mary E. D'Alton, Tarah T. Colaizy, John M. Dagle, Robin K. Ohls, Gregory M Sokol, Yvonne Loggins, Katrina Burson, Luc P. Brion, Kathleen A. Kennedy, Pablo J. Sánchez, Abbot R. Laptook, Ronald J. Wong, Roy J. Heyne, Anna Maria Hibbs, Haresh Kirpalani, Andrea Halbrook, Carol Kibler, Seetha Shankaran, Patti L. Pierce Tate, Carol H. Hartenberger, Steven J. McElroy, Dan L. Ellsbury, Diana M. Vasil, Teresa L. Gratton, Kurt Schibler, M. Bethany Ball, Michele C. Walsh, Nehal A. Parikh, Maria Batts, Abhik Das, Richard A. Ehrenkranz, Dianne E. Herron, Birju A. Shah, Marian M. Adams, Jenna Gabrio, Jennifer Jennings, Cindy Clark, Barbara J. Stoll, Robert J. Boyle, Matthew M. Laughon, Marie Gantz, Lilia C. De Jesus, Julie B. Lindower, U. Devaskar, Shawna Rodgers, Estelle E. Fischer, Kristin M. Zaterka-Baxter, Mary Christensen, David K. Stevenson, Lijun Chen, Michael G. Ross, Girija Natarajan, Nicholas Guerina, and Barbara D. Alexander

Subjects
Male, Neonatal intensive care unit, Time Factors, Developmental Disabilities, Hypothermia, Reproductive health and childbirth, Arrhythmias, Medical and Health Sciences, Hypoxic Ischemic Encephalopathy, law.invention, Randomized controlled trial, law, Hypothermia, Induced, Neonatal, Infant Mortality, Medicine, Duration (project management), Pediatric, Mortality rate, Temperature, Brain, Obstetrics and Gynecology, General Medicine, Intensive Care Units, Anesthesia, Hypoxia-Ischemia, Brain, Female, medicine.symptom, Acidosis, Cardiac, medicine.medical_specialty, Clinical Trials and Supportive Activities, Hemorrhage, Article, Clinical Research, General & Internal Medicine, Intensive Care Units, Neonatal, Hypoxia-Ischemia, Humans, Survival analysis, business.industry, Induced, Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network, Infant, Newborn, Infant, Arrhythmias, Cardiac, Thrombosis, Perinatal Period - Conditions Originating in Perinatal Period, Newborn, Survival Analysis, Surgery, Clinical trial, Relative risk, business
Abstract

Importance Hypothermia at 33.5°C for 72 hours for neonatal hypoxic ischemic encephalopathy reduces death or disability to 44% to 55%; longer cooling and deeper cooling are neuroprotective in animal models. Objective To determine if longer duration cooling (120 hours), deeper cooling (32.0°C), or both are superior to cooling at 33.5°C for 72 hours in neonates who are full-term with moderate or severe hypoxic ischemic encephalopathy. Design, Setting, and Participants A randomized, 2 × 2 factorial design clinical trial performed in 18 US centers in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network between October 2010 and November 2013. Interventions Neonates were assigned to 4 hypothermia groups; 33.5°C for 72 hours, 32.0°C for 72 hours, 33.5°C for 120 hours, and 32.0°C for 120 hours. Main Outcomes and Measures The primary outcome of death or disability at 18 to 22 months is ongoing. The independent data and safety monitoring committee paused the trial to evaluate safety (cardiac arrhythmia, persistent acidosis, major vessel thrombosis and bleeding, and death in the neonatal intensive care unit [NICU]) after the first 50 neonates were enrolled, then after every subsequent 25 neonates. The trial was closed for emerging safety profile and futility analysis after the eighth review with 364 neonates enrolled (of 726 planned). This report focuses on safety and NICU deaths by marginal comparisons of 72 hours’ vs 120 hours’ duration and 33.5°C depth vs 32.0°C depth (predefined secondary outcomes). Results The NICU death rates were 7 of 95 neonates (7%) for the 33.5°C for 72 hours group, 13 of 90 neonates (14%) for the 32.0°C for 72 hours group, 15 of 96 neonates (16%) for the 33.5°C for 120 hours group, and 14 of 83 neonates (17%) for the 32.0°C for 120 hours group. The adjusted risk ratio (RR) for NICU deaths for the 120 hours group vs 72 hours group was 1.37 (95% CI, 0.92-2.04) and for the 32.0°C group vs 33.5°C group was 1.24 (95% CI, 0.69-2.25). Safety outcomes were similar between the 120 hours group vs 72 hours group and the 32.0°C group vs 33.5°C group, except major bleeding occurred among 1% in the 120 hours group vs 3% in the 72 hours group (RR, 0.25 [95% CI, 0.07-0.91]). Futility analysis determined that the probability of detecting a statistically significant benefit for longer cooling, deeper cooling, or both for NICU death was less than 2%. Conclusions and Relevance Among neonates who were full-term with moderate or severe hypoxic ischemic encephalopathy, longer cooling, deeper cooling, or both compared with hypothermia at 33.5°C for 72 hours did not reduce NICU death. These results have implications for patient care and design of future trials. Trial Registration clinicaltrials.gov Identifier:NCT01192776

Published
2014

13. Multiple viral coinfections among HIV/AIDS patients in China

Author

Zhuohua Fu, Man Zhang, Qingwu Jiang, Haijiang Lin, Jian-hua Yang, Zuo-Feng Zhang, Baoling Rui, Jenna Gabrio, Genming Zhao, Yingying Ding, Na He, Li Chen, Roger Detels, and Jun Wei

Subjects
Male, HBsAg, China, Epstein-Barr Virus Infections, Health (social science), viruses, Hepatitis C virus, medicine.disease_cause, General Biochemistry, Genetics and Molecular Biology, Virus, Sex Factors, Acquired immunodeficiency syndrome (AIDS), HIV Seroprevalence, medicine, Seroprevalence, Humans, Hepatitis B virus, Acquired Immunodeficiency Syndrome, Herpes Genitalis, business.industry, Age Factors, virus diseases, Herpes Simplex, General Medicine, medicine.disease, Hepatitis B, Virology, Hepatitis C, Herpes simplex virus, Cross-Sectional Studies, Logistic Models, Socioeconomic Factors, Immunology, Coinfection, Female, business
Abstract

A cross-sectional survey was conducted to determine seroprevalence and correlates of coinfections of hepatitis B virus (HBV), hepatitis C virus (HCV), Epstein-Bar virus (EBV), herpes simplex virus including type 1 (HSV-1) and type 2 (HSV-2) among human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients in China. A total of 1,110 HIV/AIDS patients from Shanxi (Central area, n = 287), Zhejiang (Eastern area, n = 163), Yunnan (Southwestern area, n = 300) and Xinjiang (Northwestern area, n = 360) provinces were analyzed. The overall seroprevalence was 6.3% for HBsAg, 59.0% for anti-HCV IgG, 96.6% for anti-EBV IgG, 91.5% for anti-HSV-1 IgG, and 34.1% for anti-HSV-2 IgG. Eleven (1.0%) HIV/AIDS patients were coinfected with all five viruses, 177 (15.9%) with four viruses, 611 (55.0%) with three viruses, 288 (25.9%) with two viruses, 23 (2.1%) with single virus, and 1 (0.1%) with none of the five viruses. Multiple logistic regression analyses indicated that neither HBV, nor EBV and HSV-1 coinfection was associated with sociodemographic characteristics and HIV transmission mode, but HCV coinfection was associated with geographic region, age, gender, ethnicity, marital status, and HIV transmission mode, whereas HSV-2 coinfection was associated with geographic region, ethnicity and HIV transmission mode. This study suggests that HIV/AIDS patients with different regional and sociodemographic backgrounds and HIV transmission mode in China have different profiles of viral coinfections and should be subject to differential considerations in related health care programs.

Published
2011

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