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1. 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

2. Developmental Outcomes of Extremely Preterm Infants with a Need for Child Protective Services Supervision

Author

Elisabeth C. McGowan, Abbot. R. Laptook, Jean Lowe, Myriam Peralta-Carcelen, Dhuly Chowdhury, Rosemary D. Higgins, Susan R. Hintz, Betty R. Vohr, Richard A. Polin, Abbott R. Laptook, Martin Keszler, 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, 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, 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, Cindy Clark, Linda Manor, Diane Warner, Janice Wereszczak, David P. Carlton, Barbara J. Stoll, Ira Adams-Chapman, Ellen C. Hale, Yvonne Loggins, Stephanie Wilson Archer, Gregory M. Sokol, Brenda B. Poindexter, Anna M. Dusick, Lu-Ann Papile, Susan Gunn, Faithe Hamer, Dianne E. Herron, Abbey C. Hines, Carolyn Lytle, Heike M. Minnich, Lucy Smiley, Leslie Dawn Wilson, Pablo J. Sanchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Gail E. Besner, Nehal A. Parikh, Abhik Das, Dennis Wallace, Marie G. Gantz, W. Kenneth Poole, Jamie E. Newman, Jeanette O'Donnell Auman, Margaret M. Crawford, Carolyn M. Petrie Huitema, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, 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, Waldemar A. Carlo, Namasivayam Ambalavanan, 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, Yvonne E. Vaucher, David Kaegi, Maynard R. Rasmussen, Kathy Arnell, Clarence Demetrio, Martha G. Fuller, Wade Rich, Edward F. Bell, Tarah T. Colaizy, Michael J. Acarregui, Dan L. Ellsbury, John A. Widness, Karen J. Johnson, Donia B. Campbell, Diane L. Eastman, Jacky R. Walker, Jane E. Brumbaugh, 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, Janell F. Fuller, Robin K. Ohls, Conra Backstrom Lacy, Andrea F. Duncan, 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, Carl T. D'Angio, Dale L. Phelps, Ronnie Guillet, Satyan Lakshminrusimha, Julie Babish Johnson, Linda J. Reubens, Cassandra A. Horihan, Diane Hust, Rosemary L. Jensen, Emily Kushner, Joan Merzbach, Gary J. Myers, Mary Rowan, Holly I.M. Wadkins, Melissa Bowman, Julianne Hunn, Stephanie Guilford, Deanna Maffett, Farooq Osman, Diane Prinzing, Anne Marie Reynolds, Michael G. Sacilowski, Ashley Williams, Karen Wynn, Kelley Yost, William Zorn, Lauren Zwetsch, Kathleen A. Kennedy, Jon E. Tyson, Georgia E. McDavid, Nora I. Alaniz, Julie Arldt-McAlister, Katrina Burson, Patricia W. Evans, Carmen Garcia, Charles Green, Beverly Foley Harris, Margarita Jiminez, Janice John, Patrick M. Jones, Layne M. Lillie, Anna E. Lis, Karen Martin, Sara C. Martin, Brenda H. Morris, M. Layne Poundstone, Peggy Robichaux, Shawna Rodgers, Saba Siddiki, Maegan C. Simmons, Daniel Sperry, Patti L. Pierce Tate, Sharon L. Wright, Myra H. Wyckoff, Luc P. Brion, Roy J. Heyne, Walid A. Salhab, Charles R. Rosenfeld, Diana M. Vasil, Lijun Chen, Alicia Guzman, Gaynelle Hensley, Melissa H. Leps, Nancy A. Miller, Janet S. Morgan, Sally S. Adams, Catherine Twell Boatman, Elizabeth T. Heyne, Linda A. Madden, Lizette E. Torres, 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 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, Athina Pappas, John Barks, Rebecca Bara, Laura A. Goldston, Girija Natarajan, Mary Christensen, Stephanie A. Wiggins, Diane White, Richard A. Ehrenkranz, Harris Jacobs, Christine G. Butler, Patricia Cervone, Sheila Greisman, Monica Konstantino, JoAnn Poulsen, Janet Taft, Joanne Williams, and Elaine Romano

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Time Factors, Birth weight, Gestational Age, Prenatal care, Article, 03 medical and health sciences, 0302 clinical medicine, Child Development, stomatognathic system, Pregnancy, 030225 pediatrics, medicine, Hospital discharge, Humans, 030212 general & internal medicine, School education, Retrospective Studies, business.industry, Extremely preterm, Child Protective Services, Infant, Newborn, Infant, Cognition, Prenatal Care, Patient Discharge, United States, stomatognathic diseases, Foster care, Increased risk, Child, Preschool, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Female, business, Follow-Up Studies
Abstract

OBJECTIVE: To evaluate neurodevelopmental outcomes of preterm infants with need for Child Protective Services (CPS) supervision at hospital discharge compared with those discharged without CPS supervision. STUDY DESIGN: For infants born at

Published
2019

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. Limitations of Conventional Magnetic Resonance Imaging as a Predictor of Death or Disability Following Neonatal Hypoxic–Ischemic Encephalopathy in the Late Hypothermia Trial

Author

Abbot R. Laptook, Seetha Shankaran, Patrick Barnes, Nancy Rollins, Barbara T. Do, Nehal A. Parikh, Shannon Hamrick, Susan R. Hintz, Jon E. Tyson, Edward F. Bell, Namasivayam Ambalavanan, Ronald N. Goldberg, Athina Pappas, Carolyn Huitema, Claudia Pedroza, Aasma S. Chaudhary, Angelita M. Hensman, Abhik Das, Myra Wyckoff, Amir Khan, Michelle C. Walsh, Kristi L. Watterberg, Roger Faix, William Truog, Ronnie Guillet, Gregory M. Sokol, Brenda B. Poindexter, Rosemary D. Higgins, Michael S. Caplan, Richard A. Polin, Martin Keszler, William Oh, Betty R. Vohr, Elizabeth C. McGowan, Barbara Alksninis, Kristin Basso, Joseph Bliss, Carmena Bishop, Robert T. Burke, William Cashore, Melinda Caskey, Dan Gingras, Nicholas Guerina, Katharine Johnson, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Martha R. Leonard, Emilee Little, Bonnie E. Stephens, Elisa Vieira, Victoria E. Watson, Anna Maria Hibbs, Deanne E. Wilson-Costello, Nancy S. Newman, Beau Batton, Monika Bhola, Juliann M. Di Fiore, Harriet G. Friedman, Bonnie S. Siner, Eileen K. Stork, Gulgun Yalcinkaya, Arlene Zadell, Eugenia K. Pallotto, Howard W. Kilbride, Cheri Gauldin, Anne Holmes, Kathy Johnson, Allison Knutson, Kurt Schibler, Kimberly Yolton, Cathy Grisby, Teresa L. Gratton, Stephanie Merhar, Sandra Wuertz, C. Michael Cotten, Kimberley A. Fisher, Sandra Grimes, Joanne Finkle, Ricki F. Goldstein, Kathryn E. Gustafson, William F. Malcolm, Patricia L. Ashley, Kathy J. Auten, Melody B. Lohmeyer, Matthew M. Laughon, Carl L. Bose, Janice Bernhardt, Cindy Clark, Diane D. Warner, Janice Wereszcsak, Sofia Aliaga, David P. Carlton, Barbara J. Stoll, Ellen C. Hale, Yvonne Loggins, Diane I. Bottcher, Colleen Mackie, Maureen Mulligan LaRossa, Ira Adams-Chapman, Lynn C. Wineski, Sheena L. Carter, Stephanie Wilson Archer, Heidi M. Harmon, Lu-Ann Papile, Anna M. Dusick, Susan Gunn, Dianne E. Herron, Abbey C. Hines, Darlene Kardatzke, Carolyn Lytle, Heike M. Minnich, Leslie Richard, Lucy C. Smiley, Leslie Dawn Wilson, Kathleen A. Kennedy, Elizabeth Allain, Carrie M. Mason, Julie Arldt-McAlister, Katrina Burson, Allison G. Dempsey, Andrea F. Duncan, Patricia W. Evans, Carmen Garcia, Charles E. Green, Margarita Jimenez, Janice John, Patrick M. Jones, M. Layne Lillie, Karen Martin, Sara C. Martin, Georgia E. McDavid, Shannon McKee, Patti L. Pierce Tate, Shawna Rodgers, Saba Khan Siddiki, Daniel K. Sperry, Sharon L. Wright, Pablo J. Sánchez, Leif D. Nelin, Sudarshan R. Jadcherla, Patricia Luzader, Christine A. Fortney, Jennifer L. Grothause, Dennis Wallace, Marie G. Gantz, Kristin M. Zaterka-Baxter, Margaret M. Crawford, Scott A. McDonald, Jamie E. Newman, Jeanette O'Donnell Auman, Carolyn M. Petrie Huitema, James W. Pickett, Patricia Yost, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Barbara Bentley, Valerie Y. Chock, Elizabeth F. Bruno, Alexis S. Davis, Maria Elena DeAnda, Anne M. DeBattista, Beth Earhart, Lynne C. Huffman, Jean G. Kohn, Casey E. Krueger, Melinda S. Proud, William D. Rhine, Nicholas H. St. John, Heather Taylor, Hali E. Weiss, Waldemar A. Carlo, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Richard V. Rector, Sally Whitley, Tarah T. Colaizy, Jane E. Brumbaugh, Karen J. Johnson, Diane L. Eastman, Michael J. Acarregui, Jacky R. Walker, Claire A. Goeke, Jonathan M. Klein, Nancy J. Krutzfield, Jeffrey L. Segar, John M. Dagle, Julie B. Lindower, Steven J. McElroy, Glenda K. Rabe, Robert D. Roghair, Lauritz R. Meyer, Dan L. Ellsbury, Donia B. Campbell, Cary R. Murphy, Vipinchandra Bhavsar, Robin K. Ohls, Conra Backstrom Lacy, Sandra Sundquist Beauman, Sandra Brown, Erika Fernandez, Andrea Freeman Duncan, Janell Fuller, Elizabeth Kuan, Jean R. Lowe, Barbara Schmidt, Haresh Kirpalani, Sara B. DeMauro, Kevin C. Dysart, Soraya Abbasi, Toni Mancini, Dara M. Cucinotta, Judy C. Bernbaum, Marsha Gerdes, Hallam Hurt, Carl D'Angio, Satyan Lakshminrusimha, Nirupama Laroia, Gary J. Myers, Kelley Yost, Stephanie Guilford, Rosemary L. Jensen, Karen Wynn, Osman Farooq, Anne Marie Reynolds, Holly I.M. Wadkins, Ashley Williams, Joan Merzbach, Patrick Conway, Melissa Bowman, Michele Hartley-McAndrew, William Zorn, Cait Fallone, Kyle Binion, Constance Orme, Ann Marie Scorsone, Luc P. Brion, Lina F. Chalak, Roy J. Heyne, Lijun Chen, Diana M. Vasil, Sally S. Adams, Catherine Twell Boatman, Alicia Guzman, Elizabeth T. Heyne, Lizette E. Lee, Melissa H. Leps, Linda A. Madden, Nancy A. Miller, Emma Ramon, Bradley A. Yoder, Karen A. Osborne, Cynthia Spencer, R. Edison Steele, Mike Steffen, Karena Strong, Kimberlee Weaver-Lewis, Shawna Baker, Sarah Winter, Karie Bird, Jill Burnett, Beena G. Sood, Rebecca Bara, Kirsten Childs, Lilia C. De Jesus, Bogdan Panaitescu, Sanjay M.D. Chawla, Jeannette E. Prentice, Laura A. Goldston, Eunice Hinz Woldt, Girija Natarajan, Monika Bajaj, John Barks, Mary Christensen, and Stephanie A. Wiggins

Subjects
Male, Pediatrics, medicine.medical_specialty, Developmental Disabilities, Subgroup analysis, Severity of Illness Index, Article, Hypoxic Ischemic Encephalopathy, 03 medical and health sciences, 0302 clinical medicine, Hypothermia, Induced, Predictive Value of Tests, 030225 pediatrics, Multicenter trial, medicine, Humans, 030212 general & internal medicine, medicine.diagnostic_test, Neonatal encephalopathy, business.industry, Infant, Newborn, Area under the curve, Infant, Magnetic resonance imaging, Hypothermia, medicine.disease, Magnetic Resonance Imaging, Hypoxia-Ischemia, Brain, Pediatrics, Perinatology and Child Health, Gestation, Female, medicine.symptom, business, Infant, Premature
Abstract

Objective To investigate if magnetic resonance imaging (MRI) is an accurate predictor for death or moderate-severe disability at 18-22 months of age among infants with neonatal encephalopathy in a trial of cooling initiated at 6-24 hours. Study design Subgroup analysis of infants ≥36 weeks of gestation with moderate-severe neonatal encephalopathy randomized at 6-24 postnatal hours to hypothermia or usual care in a multicenter trial of late hypothermia. MRI scans were performed per each center's practice and interpreted by 2 central readers using the Eunice Kennedy Shriver National Institute of Child Health and Human Development injury score (6 levels, normal to hemispheric devastation). Neurodevelopmental outcomes were assessed at 18-22 months of age. Results Of 168 enrollees, 128 had an interpretable MRI and were seen in follow-up (n = 119) or died (n = 9). MRI findings were predominantly acute injury and did not differ by cooling treatment. At 18-22 months, death or severe disability occurred in 20.3%. No infant had moderate disability. Agreement between central readers was moderate (weighted kappa 0.56, 95% CI 0.45-0.67). The adjusted odds of death or severe disability increased 3.7-fold (95% CI 1.8-7.9) for each increment of injury score. The area under the curve for severe MRI patterns to predict death or severe disability was 0.77 and the positive and negative predictive values were 36% and 100%, respectively. Conclusions MRI injury scores were associated with neurodevelopmental outcome at 18-22 months among infants in the Late Hypothermia Trial. However, the results suggest caution when using qualitative interpretations of MRI images to provide prognostic information to families following perinatal hypoxia–ischemia. Trial registration Clinicaltrials.gov: NCT00614744 .

Published
2021

5. Neurodevelopmental and Behavioral Outcomes in Extremely Premature Neonates With Ventriculomegaly in the Absence of Periventricular-Intraventricular Hemorrhage

Author

Heike M. Minnich, Ivan D. Frantz, Karen J. Johnson, William E Truog, Sandra Brown, Ronnie Guillet, Myriam Peralta-Carcelen, Rosemary D. Higgins, Haresh Kirpalani, Kathryn E. Gustafson, Leslie Dawn Wilson, Gregory M Sokol, Catherine Twell Boatman, Edward F. Bell, Janet S. Morgan, W. Kenneth Poole, Amanda D. Soong, Jeanette O'Donnell Auman, Avroy A. Fanaroff, Katrina Burson, Gulgun Yalcinkaya, Monica Konstantino, Leif D. Nelin, Bradley A. Yoder, Carin Kiser, Kristin M. Basso, Marian M. Adams, Neil N. Finer, Dennis Wallace, Hali E. Weiss, Deanna Maffett, Hallam Hurt, Fred J. Biasini, Meena Garg, Laura Cole, Kathleen A. Kennedy, Julianne Hunn, Lucy Miller, Anne Holmes, Farooq Osman, Barbara Schmidt, Anna Marie Hibbs, Walid A. Salhab, Karen A. Osborne, M. Bethany Ball, Laura A. Goldston, Silvia M. Frade Eguaras, Faithe Hamer, Julie Babish Johnson, Ruth Everett-Thomas, Patti L. Pierce Tate, Maria Calejo, Michele C. Walsh, Eugenia K. Pallotto, Rachel Geller, Roger G. Faix, Melissa H. Leps, Maria Elena DeAnda, Ronald N. Goldberg, Marie G. Gantz, Sally Whitley, Nehal A. Parikh, Michelle Harwood Berkowits, Seetha Shankaran, Andrew W. Palmquist, Andrea Halbrook, Kimberlee Weaver-Lewis, Theresa M. Leach, Ira Adams-Chapman, Janice Bernhardt, Sarah Ryan, Maynard Rasmussen, Edward F. Donovan, Diana M. Vasil, Carroll Peterson, Jamie E. Newman, Bonnie E. Stephens, Karen A. Wynn, Myra H. Wyckoff, David P. Carlton, Jody Hessling, Barbara Alexander, Katherine A. Foy, Abbot R. Laptook, Michael Steffen, Sudarshan R. Jadcherla, Suzy Ventura, Raquel Halfond, Ana K. Brussa, Charles R. Rosenfeld, Ellen Waldrep, Peggy Robichaux, Donald J. Goldstein, Monika Bhola, Brenda H. Morris, Clarence Demetrio, Erica Burnell, Brenda B. Poindexter, Martha D. Carlson, Sharon L. Wright, Linda A. Madden, Michael S. Caplan, Isabell B. Purdy, Athina Pappas, Barbara Bentley, Carol Hartenberger, Patricia W. Evans, John A. Widness, Marsha Gerdes, Stephanie Wilson Archer, Kimberly Yolton, Christine G. Butler, Roy J. Heyne, Joanne Williams, Gaynelle Hensley, Carl L. Bose, Lu Ann Papile, Richard A. Polin, Brenda L. MacKinnon, JoAnn Poulsen, Anne Marie Reynolds, T. Michael O'Shea, Charles R. Bauer, Gary J. Myers, Joanne Finkle, Maegan C. Simmons, Shahnaz Duara, Arielle Rigaud, Jill Burnett, Jacky R. Walker, Lauren Zwetsch, Ellen Nylen, Margarita Jiminez, Christine A. Fortney, Angelita M. Hensman, Ellen C. Hale, Joan Merzbach, Teresa L. Gratton, Yvonne E. Vaucher, Kathy Arnell, Holly I.M. Wadkins, Sara Kryzwanski, Nancy A. Miller, Susan R. Hintz, Elaine Romano, Betty R. Vohr, Sara B. DeMauro, Donia B. Campbell, Dara M. Cucinotta, Anna Bodnar, Kristy Domnanovich, Angela Argento, Georgia E. McDavid, Kurt Schibler, Patricia L. Ashley, Margaret M. Crawford, Casey E. Krueger, Bonnie S. Siner, Sally S. Adams, Jane E. Brumbaugh, Korinne Chiu, Janice Wereszczak, Satyanarayana Lakshminrusimha, Jon E. Tyson, Carolyn Lytle, Toni Mancini, Nancy Peters, Gennie Bose, Cryshelle S. Patterson, Katharine Johnson, Barbara J. Stoll, Kristin Kirker, Gail Hounshell, Melinda S. Proud, Janet Taft, Dale L. Phelps, Keith Owen Yeates, Kathy Johnson, Dan L. Ellsbury, Martin Keszler, Leslie Rodrigues, Jennifer J. Jensen, Barbara Alksninis, Sandra Grimes, Wade Rich, Stephanie A. Wiggins, Krisa P. Van Meurs, Yvonne Loggins, M. Layne Poundstone, David Kaegi, Elizabeth T. Heyne, Sheena L. Carter, Patricia Cervone, Richard V. Rector, John M. Fiascone, Nora I. Alaniz, Helina Pierre, Waldemar A. Carlo, Kimberley A. Fisher, Elisabeth C. McGowan, Robert G. Dillard, Greg Muthig, Sarah Martin, Carolyn M. Petrie Huitema, Barbara G. Jackson, Brian G. Tang, Melinda Caskey, Vivien Phillips, Soraya Abbasi, Michael J. Acarregui, Andrea Garcia, Robert T. Burke, Aasma S. Chaudhary, Luc P. Brion, Jean G. Kohn, Kelley Yost, Melody B. Lohmeyer, Allison F. Payne, Harriet Friedman, Victoria E. Watson, William Oh, Nancy S. Newman, John Barks, Andrea H. Duncan, Pablo J. Sánchez, Mary Lenore Keszler, Deborah Evans Allred, Rosemary L. Jensen, Karie Bird, Kristin M. Zaterka-Baxter, Ann B. Cook, Alicia Guzman, Holly L. Mincey, Gail E. Besner, Kate Bridges, Sylvia Fajardo-Hiriart, Matthew M. Laughon, Cathy Grisby, Robin K. Ohls, Rebecca Bara, Karen Zanetti, Anne M. DeBattista, Tarah T. Colaizy, William F. Malcolm, Cherrie D. Welch, Judy Bernbaum, Melissa Whalen Morris, Kathleen G. Nelson, Scott A. McDonald, Emily Kushner, Abbey C. Hines, Sheila Greisman, Ashley Williams, Estelle E. Fischer, Lenora Jackson, Harris C. Jacobs, Cheri Gauldin, Alexandra Stoerger, Deanne E. Wilson-Costello, Rebecca Montman, Monica V. Collins, Mary Christensen, Charles Green, Mary Johnson, David K. Stevenson, Lijun Chen, Cecelia E. Sibley, Lisa K. Washburn, Maureen Mulligan LaRossa, Lizette E. Torres, Kathy J. Auten, Chris Henderson, U. Devaskar, Leigh Ann Smith, Janell Fuller, Diane L. Eastman, Anna E. Lis, Dianne E. Herron, Kristen C. Johnston, Anna M. Dusick, Martha G. Fuller, Anne Furey, Howard W. Kilbride, Jean R. Lowe, Elizabeth F. Bruno, Saba Siddiki, Abhik Das, Linda J. Reubens, Richard A. Ehrenkranz, Namasivayam Ambalavanan, Cynthia Spencer, Ricki F. Goldstein, Lynne C. Huffman, Teresa Chanlaw, Patricia Luzader, Carl T. D'Angio, Diane Hust, Radmila West, Beverly Foley Harris, Sarah Winter, Conra Backstrom Lacy, Shawna Baker, Shirley S. Cosby, C. Michael Cotten, and Kristi L. Watterberg

Subjects
Male, Pediatrics, medicine.medical_specialty, Gestational Age, Infant, Premature, Diseases, Bayley Scales of Infant Development, 03 medical and health sciences, 0302 clinical medicine, 030225 pediatrics, medicine, Humans, Longitudinal Studies, Original Investigation, Cerebral Hemorrhage, Retrospective Studies, Ultrasonography, business.industry, Cerebral Palsy, Infant, Newborn, Gestational age, Brain, Gross Motor Function Classification System, Odds ratio, medicine.disease, Prognosis, Intraventricular hemorrhage, Bronchopulmonary dysplasia, Neurodevelopmental Disorders, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Necrotizing enterocolitis, Female, business, 030217 neurology & neurosurgery, Ventriculomegaly, Hydrocephalus
Abstract

Importance Studies of cranial ultrasonography and early childhood outcomes among cohorts of extremely preterm neonates have linked periventricular-intraventricular hemorrhage and cystic periventricular leukomalacia with adverse neurodevelopmental outcomes. However, the association between nonhemorrhagic ventriculomegaly and neurodevelopmental and behavioral outcomes is not fully understood. Objective To characterize the outcomes of extremely preterm neonates younger than 27 weeks’ gestational age who experienced nonhemorrhagic ventriculomegaly that was detected prior to 36 weeks’ postmenstrual age. Design, Setting, and Participants This longitudinal observational study was conducted at 16 centers of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Infants born prior to 27 weeks’ gestational age in any network facility between July 1, 2006, and June 30, 2011, were included if they had a cranial ultrasonogram performed prior to 36 weeks’ postmenstrual age. Comparisons were made between those with ventriculomegaly and those with normal cranial sonograms. Data analysis was completed from August 2013 to August 2017. Main Outcomes and Measures The main outcome was neurodevelopmental impairment, defined as a Bayley Scales of Infant and Toddler Development III cognitive score less than 70, moderate/severe cerebral palsy, a Gross Motor Function Classification System score of level 2 or more, vision impairment, or hearing impairment. Secondary outcomes included Bayley Scales of Infant and Toddler Development III subscores, components of neurodevelopmental impairment, behavioral outcomes, and death/neurodevelopmental impairment. Logistic regression was used to evaluate the association of ventriculomegaly with adverse outcomes while controlling for potentially confounding variables and center differences as a random effect. Linear regression was used similarly for continuous outcomes. Results Of 4193 neonates with ultrasonography data, 300 had nonhemorrhagic ventriculomegaly (7%); 3045 had normal cranial ultrasonograms (73%), 775 had periventricular-intraventricular hemorrhage (18.5%), and 73 had cystic periventricular leukomalacia (1.7%). Outcomes were available for 3008 of 3345 neonates with ventriculomegaly or normal scans (90%). Compared with normal cranial ultrasonograms, ventriculomegaly was associated with lower gestational age, male sex, and bronchopulmonary dysplasia, late-onset sepsis, meningitis, necrotizing enterocolitis, and stage 3 retinopathy of prematurity. After adjustment, neonates with ventriculomegaly had higher odds of neurodevelopmental impairment (odds ratio [OR], 3.07; 95% CI, 2.13-4.43), cognitive impairment (OR, 3.23; 95% CI, 2.09-4.99), moderate/severe cerebral palsy (OR, 3.68; 95% CI, 2.08-6.51), death/neurodevelopmental impairment (OR, 2.17; 95% CI, 1.62-2.91), but not death alone (OR, 1.09; 95% CI, 0.76-1.57). Behavioral outcomes did not differ. Conclusions and Relevance Nonhemorrhagic ventriculomegaly is associated with increased odds of neurodevelopmental impairment among extremely preterm neonates.

Published
2017

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. 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

8. 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

9. 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

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