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1. Levetiracetam Versus Phenobarbital for Neonatal Seizures: A Randomized Controlled Trial

Author

Rema Raman, Mary J. Harbert, Karin Ernstrom, Renee Bridge, Jose Honold, Ngoc Minh Le, Rachel Kuperman, Andrew Mower, Mark Nespeca, Priscilla Joe, Ellen Knodel, Richard H. Haas, Suzanne L. Davis, Kathy Arnell, Neggy Rismanchi, Lilly Lee, Jae H. Kim, Maynard Rasmussen, Sonya Wang, Cynthia Sharpe, Jeffrey J. Gold, Malcolm R. Battin, Gail E. Reiner, David Michelson, and Brian Lane

Subjects
Drug, Phenytoin, Male, Levetiracetam, media_common.quotation_subject, law.invention, 03 medical and health sciences, Epilepsy, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Seizures, 030225 pediatrics, medicine, Humans, Adverse effect, media_common, Dose-Response Relationship, Drug, business.industry, Infant, Newborn, Articles, medicine.disease, Epilepsy, Benign Neonatal, Clinical trial, Anesthesia, Phenobarbital, Pediatrics, Perinatology and Child Health, Anticonvulsants, Female, business, medicine.drug
Abstract

BACKGROUND AND OBJECTIVES: There are no US Food and Drug Administration–approved therapies for neonatal seizures. Phenobarbital and phenytoin frequently fail to control seizures. There are concerns about the safety of seizure medications in the developing brain. Levetiracetam has proven efficacy and an excellent safety profile in older patients; therefore, there is great interest in its use in neonates. However, randomized studies have not been performed. Our objectives were to study the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment of neonatal seizures. METHODS: The study was a multicenter, randomized, blinded, controlled, phase IIb trial investigating the efficacy and safety of levetiracetam compared with phenobarbital as a first-line treatment for neonatal seizures of any cause. The primary outcome measure was complete seizure freedom for 24 hours, assessed by independent review of the EEGs by 2 neurophysiologists. RESULTS: Eighty percent of patients (24 of 30) randomly assigned to phenobarbital remained seizure free for 24 hours, compared with 28% of patients (15 of 53) randomly assigned to levetiracetam (P < .001; relative risk 0.35 [95% confidence interval: 0.22–0.56]; modified intention-to-treat population). A 7.5% improvement in efficacy was achieved with a dose escalation of levetiracetam from 40 to 60 mg/kg. More adverse effects were seen in subjects randomly assigned to phenobarbital (not statistically significant). CONCLUSIONS: In this phase IIb study, phenobarbital was more effective than levetiracetam for the treatment of neonatal seizures. Higher rates of adverse effects were seen with phenobarbital treatment. Higher-dose studies of levetiracetam are warranted, and definitive studies with long-term outcome measures are needed.

Published
2020

2. Growth Rates of Infants Randomized to Continuous Positive Airway Pressure or Intubation After Extremely Preterm Birth

Author

Jean R. Lowe, Yvonne E. Vaucher, Ira Adams-Chapman, Elizabeth F. Bruno, Paul Zlotnik, Kristin M. Zaterka-Baxter, Nancy Close, Alicia Guzman, Susan R. Hintz, Amanda Soong, Wade Rich, Alexandra Stroerger, Seetha Shankaran, Saba Siddiki, Sharon L. Wright, Kimberlee Weaver-Lewis, Gary David Markowitz, Linda Black, Anne M. DeBattista, Donald J. Goldstein, Monika Bhola, Marcia Worley Mersmann, Brenda H. Morris, Vivek Narendran, Patricia L. Ashley, Theresa M. Leach, Barbara J. Stoll, Gail Hounshell, Kim Francis, M. Bethany Ball, Laura A. Goldston, Michele C. Walsh, Amy K. Hutchinson, Tarah T. Colaizy, David K. Stevenson, Lisa K. Washburn, Meghan Lukasik, Abhik Das, Linda J. Reubens, Maureen Mulligan LaRossa, Rene Barbieri-Welge, John M. Fiascone, Ann B. Cook, Jon E. Tyson, Carlos Torres, Renee Bridge, Melinda S. Proud, John A. Widness, Stephanie Wilson Archer, Kathleen G. Nelson, Kristi L. Watterberg, Katherine A. Foy, Abbot R. Laptook, Dan Gingras, Bradley A. Yoder, Michelle Harwood Berkowits, Richard A. Ehrenkranz, Janet Taft, Neil N. Finer, Fred J. Biasini, J. M. DiFiore, James P. Kiley, Anthony J. Piazza, Shahnaz Duara, William F. Malcolm, Lizette E. Torres, Kathy J. Auten, Dianne E. Herron, Mike Steffens, Nancy Peters, Sally Whitley, Nancy S. Newman, Charles R. Rosenfeld, Nancy A. Miller, Sarah Martin, Beverly Foley Harris, Conra Backstrom Lacy, Linda A. Madden, Gloria V. Smikle, Kathy Arnell, Kristen C. Johnston, Anna M. Dusick, Martha G. Fuller, Heike M. Minnich, Vineet Bhandari, Donna Posin, Kate Bridges, Martha R. Leonard, Roy J. Heyne, Noelle Younge, Christine G. Butler, Patricia Gettner, Carolyn M. Petrie Huitema, Sharon F. Freedman, Rachel V. Walden, Helina Pierre, Waldemar A. Carlo, Robert G. Dillard, Joanne Williams, Ellen Nylen, Margarita Jiminez, Victoria E. Watson, Sheena L. Carter, Richard V. Rector, Barbara Alksninis, David Wang, Bill Cashore, Kimberley A. Fisher, Susie Buchter, Michael J. Acarregui, Bonnie E. Stephens, Alexis N. Diaz, W. Kenneth Poole, Ana K. Brussa, Alexis S. Davis, Carolyn Lytle, Jill Burnett, Laura Grau, Bonnie S. Siner, Melissa Whalen Morris, Karen A. Osborne, Melinda Caskey, Cryshelle S. Patterson, Renee P. Pyle, Laura L. Whitely, Harriet Friedman, Sheree York, Kelley Yost, Emily Kushner, Rebecca Bara, Cathy Grisby, Arlene Zadell, Barbara D. Alexander, Ivan D. Frantz, Myriam Peralta-Carcelen, James W. Pickett, Karen J. Johnson, Sheila Greisman, Susan Barnett, Beena G. Sood, Ann M. Blackwelder, Catherine Twell Boatman, Gary J. Myers, Athina Pappas, Ariel A. Salas, Jean G. Kohn, Ayala Ben-Tall, Ellen C. Hale, Brenda B. Poindexter, Rosemary D. Higgins, Elisabeth Dinkins, Elizabeth T. Heyne, Teresa L. Gratton, Kerry Wilder, Jonathan W. Mink, Regina A. Gargus, Deanne E. Wilson-Costello, Rebecca Montman, Charles R. Bauer, Dale L. Phelps, Jamie E. Newman, Leslie Dawn Wilson, Pablo J. Sánchez, Alan H. Jobe, Monica Konstantino, Melody B. Lohmeyer, Monica V. Collins, Charles Green, Hali E. Weiss, Elizabeth Billian, Dorothy B. Gail, Clarence Demetrio, Kurt Schibler, Mary Anne Berberich, Leslie Rodriguez, David K. Wallace, Shabnam Lainwala, Betty R. Vohr, Sobha Fritz, Kasey Hamlin-Smith, William Oh, Deborah Pontillo, David P. Carlton, Cheryl Runyan, Arielle Riguard, Shawna Baker, Avroy A. Fanaroff, Sara Krzywanski, Shirley S. Cosby, Barbara Bentley, Gaynelle Hensley, Walid A. Salhab, Joan Merzbach, Cecelia E. Sibley, James Allen, Elaine Romano, C. Michael Cotten, Maria Hopkins, Vivien Phillips, Kimberly Yolton, Michael S. Caplan, Kathryn E. Gustafson, Andrea Milena Becerra Garcia, Kirstin J. Bailey, Margaret L. Poundstone, Diana M. Vasil, Cherrie D. Welch, Sarah Lillie, Ellen Waldrep, Jeanette O'Donnell Auman, Gulgun Yalcinkaya, Kalida Mehta, Patricia W. Evans, Harris Gelbard, Carroll Peterson, Angelita M. Hensman, Sylvia Hiriart-Fajardo, Edward F. Donovan, Barbara Do, James Wilkes, Marie G. Gantz, Nicholas H. St. John, Elaine O. Mathews, Harris C. Jacobs, Deborah Evans Allred, Rosemary L. Jensen, Suzy Ventura, Kathleen A. Kennedy, Dawn Andrews, Walter Gilliam, Kristen Angela, Mary Johnson, Katharine Johnson, Krisa P. Van Meurs, Barbara G. Jackson, Betty K. Hastings, Holly L. Mincey, Elisabeth C. McGowan, Brenda L. MacKinnon, JoAnn Poulsen, Pat Cervone, Edward F. Bell, T. Michael O'Shea, Janet S. Morgan, Elaine Ito, Julie Rohr, Ruth Everett-Thomas, Patti L. Pierce Tate, Laura Cole, Maria Calejo, Dennis Wallace, Paul Wozniak, Maynard Rasmussen, Robin K. Ohls, Lisa Augostino, Silvia M. Frade Eguaras, Faithe Hamer, Julie Babish Johnson, Karen Zanetti, Roger G. Faix, Maria Elena DeAnda, Ronald N. Goldberg, James A. Lemons, Diane Hust, Stacy Reddoch, Karie Bird, Jody Hessling, Araceli Solis, Carol J. Blaisdell, Raquel Halfond, Erica Burnell, Nirupama Laroia, Georgia E. McDavid, Namasivayam Ambalavanan, Sally S. Adams, Korinne Chiu, Cynthia Spencer, Lucy Noel, Melissa Martin, Nora I. Alaniz, James R. Moore, Ricki F. Goldstein, Janell Fuller, Melissa H. Lepps, Anne Furey, Diane L. Eastman, Jonathan M. Klein, and Anna E. Lis

Subjects
Male, Pediatrics, medicine.medical_specialty, Birth weight, medicine.medical_treatment, Gestational Age, Lower risk, Article, Child Development, Positive airway pressure, Intubation, Intratracheal, medicine, Humans, Intubation, Oximetry, Continuous positive airway pressure, Respiratory Distress Syndrome, Newborn, Continuous Positive Airway Pressure, business.industry, Infant, Newborn, Postmenstrual Age, Gestational age, Pulmonary Surfactants, Neurodevelopmental Disorders, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Gestation, Female, Energy Intake, business
Abstract

OBJECTIVE: To evaluate the effects of early treatment with CPAP on nutritional intake and in-hospital growth rates of extremely preterm (EPT) infants. STUDY DESIGN: EPT infants (24–0/7 to 27–6/7 weeks of gestation) enrolled in the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) were included. EPT infants who died before 36 weeks’ postmenstrual age (PMA) were excluded. The growth rates from birth to 36 weeks’ PMA and follow-up outcomes at 18–22 months’ corrected age of EPT infants randomized at birth to either early CPAP (intervention group) or early intubation for surfactant administration (control group) were analyzed. RESULTS: 810 of 1316 infants enrolled in SUPPORT (414 in intervention group, 396 in control group) had growth data analyzed. Median gestational age was 26 weeks and mean birthweight was 839 grams. Baseline characteristics, total nutritional intake, and in-hospital comorbidities were not significantly different between groups. In a regression model, growth rates between birth and 36 weeks’ PMA as well as growth rates during multiple intervals from birth to day 7, day 7 to14, day 14 to 21, day 21 to 28, day 28 to 32 weeks’ PMA, and 32 weeks’ PMA to 36 weeks’ PMA did not differ between treatment groups. Independent of treatment group, higher growth rates from day 21 to day 28 were associated with a lower risk of Bayley III cognitive score

Published
2021
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3. Prolonged Tracheal Intubation and the Association Between Patent Ductus Arteriosus and Bronchopulmonary Dysplasia: A Secondary Analysis of the PDA-TOLERATE trial

Author

Ronald I. Clyman, Joseph Kaempf, Melissa Liebowitz, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W. Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Erika Fernandez, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Scott Fields, Lora Whitten, Stefanie Rogers, Emel Okulu, Gaffari Tunc, Tayfun Ucar, Ebru Türkoglu Ünal, Jane Steen, Kathy Arnell, Sarah Holtschlag, Michael Schreiber, Caryn Peters, Maureen Gilmore, Lorna McKay, Dianne Carole, Annette Shaw, Malinda Harris, Amy Amsbaugh, Lavonne M. Liedl, Sue Wolf, Avi Groner, Amy Kimball, Jae Kim, Renee Bridge, Ellen Knodel, Chrissy Weng, Magaly Diaz Barbosa, Richard Polin, Marilyn Weindler, Shahab Noori, Jeffrey Reese, and Yao Sun

Subjects
Male, Time Factors, health care facilities, manpower, and services, medicine.medical_treatment, Cardiovascular, Low Birth Weight and Health of the Newborn, Severity of Illness Index, Pediatrics, 0302 clinical medicine, Ductus arteriosus, Secondary analysis, Infant Mortality, Prospective Studies, 030212 general & internal medicine, Ductus Arteriosus, Patent, Lung, Bronchopulmonary Dysplasia, Pediatric, Respiration, premature birth, medicine.anatomical_structure, Premature birth, Anesthesia, Artificial, Patent, Female, congenital, hereditary, and neonatal diseases and abnormalities, education, PDA-TOLERATE Trial Investigators, Neonatal Respiratory Distress, Paediatrics and Reproductive Medicine, patent ductus arteriosus, 03 medical and health sciences, Preterm, health services administration, 030225 pediatrics, bronchopulmonary dysplasia, Intubation, Intratracheal, medicine, Humans, cardiovascular diseases, business.industry, Prevention, Tracheal intubation, Infant, Newborn, Infant, Ductus Arteriosus, Human Movement and Sports Sciences, Perinatal Period - Conditions Originating in Perinatal Period, Newborn, medicine.disease, Respiration, Artificial, Intratracheal, Good Health and Well Being, Increased risk, Bronchopulmonary dysplasia, Pediatrics, Perinatology and Child Health, Intubation, business
Abstract

In the PDA-TOLERATE trial, persistent (even for several weeks) moderate to large patent ductus arteriosus (PDA) was not associated with an increased risk of BPD when the infant required

Published
2021
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4. PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

Author

Ronald I. Clyman, Melissa Liebowitz, Joseph Kaempf, Omer Erdeve, Ali Bulbul, Stellan Håkansson, Johanna Lindqvist, Aijaz Farooqi, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly Nelson, Andrea Wickremasinghe, Lawrence Dong, Denise C. Hassinger, Susan W. Aucott, Madoka Hayashi, Anne Marie Heuchan, William A. Carey, Matthew Derrick, Erika Fernandez, Meera Sankar, Tina Leone, Jorge Perez, Arturo Serize, Scott Fields, Lora Whitten, Stefanie Rogers, Emel Okulu, Gaffari Tunc, Tayfun Ucar, Ebru Türkoglu Ünal, Jane Steen, Kathy Arnell, Sarah Holtschlag, Michael Schreiber, Caryn Peters, Maureen Gilmore, Lorna McKay, Dianne Carole, Annette Shaw, Malinda Harris, Amy Amsbaugh, Lavonne M. Liedl, Sue Wolf, Avi Groner, Amy Kimball, Jae Kim, Renee Bridge, Ellen Knodel, Chrissy Weng, Magaly Diaz Barbosa, Richard Polin, Marilyn Weindler, Shahab Noori, Jeffrey Reese, and Yao Sun

Subjects
Male, medicine.medical_treatment, Indomethacin, Ibuprofen, Reproductive health and childbirth, Conservative Treatment, Low Birth Weight and Health of the Newborn, Pediatrics, law.invention, Randomized controlled trial, law, newborn, Ductus arteriosus, Infant Mortality, Medicine, retinopathy of prematurity, Single-Blind Method, Continuous positive airway pressure, Prospective Studies, Ductus Arteriosus, Patent, Lung, Pediatric, Continuous Positive Airway Pressure, Gestational age, Retinopathy of prematurity, Hematology, premature birth, medicine.anatomical_structure, Treatment Outcome, Premature birth, Anesthesia, Infant, Extremely Premature, Necrotizing enterocolitis, Patent, Female, congenital, hereditary, and neonatal diseases and abnormalities, Clinical Trials and Supportive Activities, Gestational Age, Extremely Premature, TO LEave it alone or Respond And Treat Early) Trial Investigators [PDA-TOLERATE (PDA], Paediatrics and Reproductive Medicine, Clinical Research, Preterm, bronchopulmonary dysplasia, Humans, Cyclooxygenase Inhibitors, Acetaminophen, necrotizing enterocolitis, business.industry, Infant, Newborn, nutritional and metabolic diseases, Infant, Ductus Arteriosus, Human Movement and Sports Sciences, Perinatal Period - Conditions Originating in Perinatal Period, medicine.disease, Good Health and Well Being, Bronchopulmonary dysplasia, Pediatrics, Perinatology and Child Health, business, Digestive Diseases
Abstract

ObjectiveTo compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given.Study designA total of 202 neonates of

Published
2019

5. Behavioral Deficits at 18-22 Months of Age Are Associated with Early Cerebellar Injury and Cognitive and Language Performance in Children Born Extremely Preterm

Author

Andrea F. Duncan, Carla M. Bann, Allison Dempsey, Myriam Peralta-Carcelen, Susan Hintz, Alan H. Jobe, Michael S. Caplan, Abbot R. Laptook, Betty R. Vohr, William Oh, Angelita M. Hensman, Barbara Alksninis, Dawn Andrews, Kristen Angela, Susan Barnett, Bill Cashore, Melinda Caskey, Kim Francis, Dan Gingras, Katharine Johnson, Theresa M. Leach, Bonnie E. Stephens, Victoria E. Watson, Michele C. Walsh, Avroy A. Fanaroff, Nancy S. Newman, Deanne E. Wilson-Costello, Bonnie S. Siner, Arlene Zadell, Julie DiFiore, Monika Bhola, Harriet G. Friedman, Gulgun Yalcinkaya, Dorothy Bulas, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, Patricia Ashley, Kathy J. Auten, Kimberley A. Fisher, Katherine A. Foy, Sharon F. Freedman, Kathryn E. Gustafson, Melody B. Lohmeyer, William F. Malcolm, David K. Wallace, David P. Carlton, Barbara J. Stoll, Ira Adams-Chapman, Susie Buchter, Anthony J. Piazza, Sheena Carter, Sobha Fritz, Ellen C. Hale, Amy K. Hutchinson, Maureen Mulligan LaRossa, Rosemary D. Higgins, Stephanie Wilson Archer, Gregory M. Sokol, Brenda B. Poindexter, Anna M. Dusick, James A. Lemons, Leslie D. Wilson, Faithe Hamer, Ann B. Cook, Dianne E. Herron, Carolyn Lytle, Heike M. Minnich, Mary Anne Berberich, Carol J. Blaisdell, Dorothy B. Gail, James P. Kiley, Abhik Das, Marie G. Gantz, Jamie E. Newman, Helen Cheng, Betty K. Hastings, Elizabeth M. McClure, Jeanette O'Donnell Auman, Carolyn Petrie Huitema, W. Kenneth Poole, James W. Pickett, Dennis Wallace, Lisa A. Wrage, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Patrick D. Barnes, Barbara Bentley, Elizabeth F. Bruno, Maria Elena DeAnda, Anne M. DeBattista, Jean G. Kohn, Melinda S. Proud, Renee P. Pyle, Hali E. Weiss, Ivan D. Frantz, John M. Fiascone, Elisabeth C. McGowan, Anne Furey, Brenda L. MacKinnon, Ellen Nylen, Ana Brussa, Cecelia Sibley, Waldemar A. Carlo, Namasivayam Ambalavanan, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Kirstin J. Bailey, Fred J. Biasini, Maria Hopkins, Kristen C. Johnston, Kathleen G. Nelson, Cryshelle S. Patterson, Richard V. Rector, Leslie Rodriguez, Amanda Soong, Sally Whitley, Sheree York, Neil N. Finer, Maynard R. Rasmussen, Paul R. Wozniak, Yvonne E. Vaucher, Wade Rich, Kathy Arnell, Rene Barbieri-Welge, Ayala Ben-Tall, Renee Bridge, Clarence Demetrio, Martha G. Fuller, Elaine Ito, Meghan Lukasik, Deborah Pontillo, Donna Posin, Cheryl Runyan, James Wilkes, Paul Zlotnik, Edward F. Bell, John A. Widness, Michael J. Acarregui, Jonathan M. Klein, Tarah T. Colaizy, Karen J. Johnson, Diane L. Eastman, Shahnaz Duara, Charles R. Bauer, Ruth Everett-Thomas, Maria Calejo, Alexis N. Diaz, Silvia M. Frade Eguaras, Andrea Garcia, Kasey Hamlin-Smith, Michelle Harwood Berkowits, Sylvia Hiriart-Fajardo, Elaine O. Mathews, Helina Pierre, Arielle Riguard, Alexandra Stroerger, Kristi L. Watterberg, Robin K. Ohls, Janell Fuller, Julie Rohr, Conra Backstrom Lacy, Jean Lowe, Rebecca Montman, Sandra Brown, Nirupama Laroia, Dale L. Phelps, Gary J. Myers, Gary D. Markowitz, Linda J. Reubens, Diane Hust, Lisa Augostino, Julie Babish Johnson, Erica Burnell, Harris Gelbard, Rosemary L. Jensen, Emily Kushner, Joan Merzbach, Jonathan Mink, Carlos Torres, David Wang, Kelley Yost, Pablo J. Sánchez, Charles R. Rosenfeld, Walid A. Salhab, Roy J. Heyne, Sally S. Adams, James Allen, Laura Grau, Alicia Guzman, Gaynelle Hensley, Elizabeth T. Heyne, Jackie F. Hickman, Melissa H. Leps, Linda A. Madden, Melissa Martin, Nancy A. Miller, Janet S. Morgan, Araceli Solis, Lizette E. Torres, Catherine Twell Boatman, Diana M. Vasil, Kathleen A. Kennedy, Jon E. Tyson, Patricia W. Evans, Esther G. Akpa, Nora I. Alaniz, Beverly Foley Harris, Charles Green, Margarita Jiminez, Anna E. Lis, Sarah Martin, Georgia E. McDavid, Brenda H. Morris, Margaret L. Poundstone, Stacy Reddoch, Saba Siddiki, Patti L. Pierce Tate, Sharon L. Wright, Bradley A. Yoder, Roger G. Faix, Shawna Baker, Karie Bird, Anna E. Bullwinkle, Jill Burnett, Laura Cole, Karen A. Osborne, Cynthia Spencer, R. Edison Steele, Michael Steffen, Kimberlee Weaver-Lewis, T. Michael O'Shea, Robert G. Dillard, Lisa K. Washburn, Nancy J. Peters, Barbara G. Jackson, 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, Thomas L. Slovis, Athina Pappas, Rebecca Bara, Elizabeth Billian, Laura A. Goldston, and Mary Johnson

Subjects
Male, Pediatrics, medicine.medical_specialty, Ultrasonography, Doppler, Transcranial, Neuroimaging, Neuropsychological Tests, Bayley Scales of Infant Development, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Child Development, Cerebellar Diseases, 030225 pediatrics, Medicine, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Competence (human resources), business.industry, Brain, Infant, Cognition, Child development, Magnetic Resonance Imaging, Language development, Neurodevelopmental Disorders, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Female, business, Cohort study
Abstract

Objective To investigate associations in toddlers born extremely preterm ( Study design Cohort analysis from the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network Surfactant Positive Airway Pressure and Pulse Oximetry Trial Neuroimaging and Neurodevelopmental Outcomes Study of infants born extremely preterm. Subjects underwent cranial ultrasonography and near-term magnetic resonance imaging (MRI). At 18-22 months of corrected age, the assessment included the Brief Infant Toddler Social Emotional Assessment (BITSEA) Problem and Competence Scale scores and the Bayley Scales of Infant Development, Third Edition (Bayley-III). The BITSEA Problem Scale assesses dysregulation; the Competence Scale assesses social-emotional competence. We examined associations of Problem and Competence scores and positive screen rates with cranial ultrasonography and near-term MRI. Mean BITSEA and Bayley-III scores were compared using ANOVA and positive screen rates with the χ2 test. We computed correlations between BITSEA and Bayley-III scores. Results Of the 397 children, positive BITSEA screens were found in 34% for the Problem score and 26% for the Competence score. Presence of lesions on near-term MRI that included cerebellar lesions were significantly associated with lower BITSEA Competence but not with Problem scores; Competence scores were inversely related to the presence/significance of lesions. Positive screens on Competence scores and on both Competence and Problem scores were significantly associated with Bayley-III cognitive and language scores Conclusions Social–emotional competence contributes to deficits in cognitive and language development. Presence of injury on near-term MRI that includes cerebellar lesions is associated with later social–emotional competence and may be a useful predictor to guide early assessment and intervention. Trial registration ClinicalTrials.gov : NCT00063063 and NCT00233324 .

Published
2018

6. Markers of Successful Extubation in Extremely Preterm Infants, and Morbidity After Failed Extubation

Author

Sanjay Chawla, Girija Natarajan, Seetha Shankaran, Benjamin Carper, Luc P. Brion, Martin Keszler, Waldemar A. Carlo, Namasivayam Ambalavanan, Marie G. Gantz, Abhik Das, Neil Finer, Ronald N. Goldberg, C. Michael Cotten, Rosemary D. Higgins, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, William Oh, Angelita M. Hensman, Dan Gingras, Susan Barnett, Sarah Lillie, Kim Francis, Dawn Andrews, Kristen Angela, Michele C. Walsh, Avroy A. Fanaroff, Nancy S. Newman, Bonnie S. Siner, Kurt Schibler, Edward F. Donovan, Vivek Narendran, Kate Bridges, Barbara Alexander, Cathy Grisby, Marcia Worley Mersmann, Holly L. Mincey, Jody Hessling, Kathy J. Auten, Kimberly A. Fisher, Katherine A. Foy, Gloria Siaw, Barbara J. Stoll, Susie Buchter, Anthony Piazza, David P. Carlton, Ellen C. Hale, Stephanie Wilson Archer, Brenda B. Poindexter, James A. Lemons, Faithe Hamer, Dianne E. Herron, Lucy C. Miller, Leslie D. Wilson, Mary Anne Berberich, Carol J. Blaisdell, Dorothy B. Gail, James P. Kiley, W. Kenneth Poole, Margaret Cunningham, Betty K. Hastings, Amanda R. Irene, Jeanette O'Donnell Auman, Carolyn Petrie Huitema, James W. Pickett, Dennis Wallace, Kristin M. Zaterka-Baxter, Krisa P. Van Meurs, David K. Stevenson, M. Bethany Ball, Melinda S. Proud, Ivan D. Frantz, John M. Fiascone, Anne Furey, Brenda L. MacKinnon, Ellen Nylen, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Maynard R. Rasmussen, Paul R. Wozniak, Wade Rich, Kathy Arnell, Renee Bridge, Clarence Demetrio, Edward F. Bell, John A. Widness, Jonathan M. Klein, Karen J. Johnson, Shahnaz Duara, Ruth Everett-Thomas, Kristi L. Watterberg, Robin K. Ohls, Julie Rohr, Conra Backstrom Lacy, Dale L. Phelps, Nirupama Laroia, Linda J. Reubens, Erica Burnell, Pablo J. Sánchez, Charles R. Rosenfeld, Walid A. Salhab, James Allen, Alicia Guzman, Gaynelle Hensley, Melissa H. Lepps, Melissa Martin, Nancy A. Miller, Araceli Solis, Diana M. Vasil, Kerry Wilder, Kathleen A. Kennedy, Jon E. Tyson, Brenda H. Morris, Beverly Foley Harris, Anna E. Lis, Sarah Martin, Georgia E. McDavid, Patti L. Tate, Sharon L. Wright, Bradley A. Yoder, Roger G. Faix, Jill Burnett, Jennifer J. Jensen, Karen A. Osborne, Cynthia Spencer, Kimberlee Weaver-Lewis, T. Michael O'Shea, Nancy J. Peters, Beena G. Sood, Rebecca Bara, Elizabeth Billian, Mary Johnson, Richard A. Ehrenkranz, Harris C. Jacobs, Vineet Bhandari, Pat Cervone, Patricia Gettner, Monica Konstantino, JoAnn Poulsen, and Janet Taft

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Positive pressure, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, 030225 pediatrics, Fraction of inspired oxygen, medicine, Intubation, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Treatment Failure, Respiratory Distress Syndrome, Newborn, business.industry, Infant, Newborn, Gestational age, Pulmonary Surfactants, medicine.disease, Surgery, Bronchopulmonary dysplasia, Anesthesia, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Airway Extubation, Apgar score, Female, Morbidity, business, Infant, Premature
Abstract

Objectives To identify variables associated with successful elective extubation, and to determine neonatal morbidities associated with extubation failure in extremely preterm neonates. Study design This study was a secondary analysis of the National Institute of Child Health and Human Development Neonatal Research Network's Surfactant, Positive Pressure, and Oxygenation Randomized Trial that included extremely preterm infants born at 240/7 to 276/7 weeks' gestation. Patients were randomized either to a permissive ventilatory strategy (continuous positive airway pressure group) or intubation followed by early surfactant (surfactant group). There were prespecified intubation and extubation criteria. Extubation failure was defined as reintubation within 5 days of extubation. Results Of 1316 infants in the trial, 1071 were eligible; 926 infants had data available on extubation status; 538 were successful and 388 failed extubation. The rate of successful extubation was 50% (188/374) in the continuous positive airway pressure group and 63% (350/552) in the surfactant group. Successful extubation was associated with higher 5-minute Apgar score, and pH prior to extubation, lower peak fraction of inspired oxygen within the first 24 hours of age and prior to extubation, lower partial pressure of carbon dioxide prior to extubation, and non-small for gestational age status after adjustment for the randomization group assignment. Infants who failed extubation had higher adjusted rates of mortality (OR 2.89), bronchopulmonary dysplasia (OR 3.06), and death/ bronchopulmonary dysplasia (OR 3.27). Conclusions Higher 5-minute Apgar score, and pH prior to extubation, lower peak fraction of inspired oxygen within first 24 hours of age, lower partial pressure of carbon dioxide and fraction of inspired oxygen prior to extubation, and nonsmall for gestational age status were associated with successful extubation. Failed extubation was associated with significantly higher likelihood of mortality and morbidities. Trial registration ClinicalTrials.gov : NCT00233324 .

Published
2017

7. Patterns of Oxygenation, Mortality, and Growth Status in the Surfactant Positive Pressure and Oxygen Trial Cohort

Author

Charles R. Rosenfeld, Marcia Worley Mersmann, Edward F. Bell, Kristin M. Zaterka-Baxter, Kristi L. Watterberg, Alicia Guzman, Lucy Miller, Ruth Everett-Thomas, James P. Kiley, Faithe Hamer, Marie G. Gantz, M. Bethany Ball, Beverly Foley Harris, Karen J. Johnson, Conra Backstrom Lacy, Susan Barnett, Kate Bridges, Sarah Lillie, Pat Cervone, Laura Grau, Gaynelle Hensley, Kerry Wilder, Richard A. Ehrenkranz, Ellen C. Hale, Maynard Rasmussen, David K. Stevenson, Kristen Angela, Betty K. Hastings, Kurt Schibler, Angelita M. Hensman, Nancy S. Newman, Amy K. Hutchinson, Kim Francis, Nancy Peters, Mary Anne Berberich, Dennis Wallace, Beena G. Sood, Brenda H. Morris, Michele C. Walsh, Michael S. Caplan, John A. Widness, Harris C. Jacobs, Dawn Andrews, Krisa P. Van Meurs, Stephanie Wilson Archer, Mary Johnson, Ivan D. Frantz, Nathan Morris, Sarah Martin, Alan H. Jobe, Diana M. Vasil, T. Michael O'Shea, Shahnaz Duara, Carolyn M. Petrie Huitema, Ronald N. Goldberg, Dale L. Phelps, Margaret M. Crawford, Sharon F. Freedman, Shirley S. Cosby, Jeanette O'Donnell Auman, C. Michael Cotten, Ellen Nylen, Monica V. Collins, Elizabeth Billian, Patricia Gettner, Kathleen A. Kennedy, Richard A. Polin, Waldemar A. Carlo, Avroy A. Fanaroff, Roger G. Faix, Gary David Markowitz, James A. Lemons, Katherine A. Foy, Abbot R. Laptook, James Allen, Brenda B. Poindexter, Kimberly A. Fisher, Bradley A. Yoder, David K. Wallace, Seetha Shankaran, Walid A. Salhab, Brenda L. MacKinnon, JoAnn Poulsen, Kimberlee Weaver-Lewis, Susie Buchter, Karen A. Osborne, Nancy A. Miller, Jill Burnett, Arlene Zadell, William Oh, Sharon L. Wright, Juliann M. Di Fiore, Kathy J. Auten, Namasivayam Ambalavanan, Vineet Bhandari, Barbara Alexander, Renee Bridge, Melinda S. Proud, Holly L. Mincey, Julie Rohr, Janet Taft, Cynthia Spencer, Cathy Grisby, Robin K. Ohls, Bonnie S. Siner, Monica Konstantino, Abhik Das, Patti L. Pierce Tate, Paul Wozniak, Melissa Martin, Linda J. Reubens, Barbara J. Stoll, Jennifer J. Jensen, Hong Li, Anthony J. Piazza, David P. Carlton, Wade Rich, Dianne E. Herron, Amanda R. Irene, Vivien Phillips, Georgia E. McDavid, Jody Hessling, Araceli Solis, Carol J. Blaisdell, Erica Burnell, Nirupama Laroia, Richard J. Martin, Kathy Arnell, Rebecca Bara, Clarence Demetrio, John M. Fiascone, Jonathan M. Klein, Anna E. Lis, Melissa H. Lepps, Vivek Narendran, Anne Furey, Jon E. Tyson, Edward F. Donovan, Dan Gingras, James W. Pickett, Rosemary D. Higgins, Leslie Dawn Wilson, Pablo J. Sánchez, Dorothy B. Gail, and Neil N. Finer

Subjects
Male, medicine.medical_specialty, Pediatrics, medicine.medical_treatment, Positive pressure, Gestational Age, Infant, Premature, Diseases, Article, Hypoxemia, Cohort Studies, 03 medical and health sciences, Surface-Active Agents, 0302 clinical medicine, 030225 pediatrics, Internal medicine, Medicine, Humans, 030212 general & internal medicine, Continuous positive airway pressure, Hypoxia, Oxygen saturation, Survival rate, Continuous Positive Airway Pressure, business.industry, Hazard ratio, Infant, Newborn, Oxygen Inhalation Therapy, Infant, Pulmonary Surfactants, Oxygenation, medicine.disease, Oxygen, Survival Rate, Infant, Extremely Premature, Pediatrics, Perinatology and Child Health, Infant, Small for Gestational Age, Cardiology, Small for gestational age, Female, medicine.symptom, business
Abstract

Objective To characterize actual achieved patterns of oxygenation in infants born appropriate vs small for gestational age (SGA) randomized to a lower (85-89%) vs higher (91%-95%) oxygen saturation target in the Surfactant Positive Pressure and Oxygen Trial. To determine the association between achieved oxygen saturation levels and survival in infants born appropriate vs SGA enrolled in the Surfactant Positive Pressure and Oxygen Trial. Study design Median oxygen saturation and intermittent hypoxemia events ( 0/7 -27 6/7 weeks of gestation while receiving supplemental oxygen during the first 3 days of life. Results Lower target infants who were small for gestational age had the lowest oxygen saturation and highest incidence of intermittent hypoxemia during the first 3 days of life. The lowest quartile of oxygen saturation (≤92%) during the first 3 days of life was associated with lower 90-day survival for both infants born appropriate and SGA. An increased incidence of intermittent hypoxemia events during the first 3 days of life was associated with lower 90-day survival only in infants born SGA. Conclusion Lower achieved oxygen saturation during the first 3 days of life was associated with lower 90-day survival in extremely preterm infants. Infants born SGA had enhanced vulnerability to lower oxygen saturation targets as evidenced by lower achieved oxygen saturation and an association between increased intermittent hypoxemia events and lower survival. Trial registration ClinicalTrials.gov: NCT00233324.

Published
2016

8. Extreme Preterm Infant Rates of Overweight and Obesity at School Age in the SUPPORT Neuroimaging and Neurodevelopmental Outcomes Cohort

Author

Betty R. Vohr, Roy Heyne, Carla M. Bann, Abhik Das, Rosemary D. Higgins, Susan R. Hintz, Alan H. Jobe, Michael S. Caplan, Richard A. Polin, Abbot R. Laptook, Angelita M. Hensman, Elisabeth C. McGowan, Elisa Vieira, Emilee Little, Katharine Johnson, Barbara Alksninis, Mary Lenore Keszler, Andrea M. Knoll, Theresa M. Leach, Victoria E. Watson, Michele C. Walsh, Avroy A. Fanaroff, Deanne E. Wilson-Costello, Allison Payne, Nancy S. Newman, H. Gerry Taylor, Bonnie S. Siner, Arlene Zadell, Julie DiFiore, Monika Bhola, Harriet G. Friedman, Gulgun Yalcinkaya, Dorothy Bulas, Ronald N. Goldberg, C. Michael Cotten, Ricki F. Goldstein, Kathryn E. Gustafson, Patricia Ashley, Kathy J. Auten, Kimberley A. Fisher, Katherine A. Foy, Sharon F. Freedman, Melody B. Lohmeyer, William F. Malcolm, David K. Wallace, David P. Carlton, Barbara J. Stoll, Ira Adams-Chapman, Susie Buchter, Anthony J. Piazza, null Carter, Sobha Fritz, Ellen C. Hale, Amy K. Hutchinson, Maureen Mulligan LaRossa, Yvonne Loggins, Diane Bottcher, Stephanie Wilson Archer, Brenda B. Poindexter, Gregory M. Sokol, Heidi M. Harmon, Lu-Ann Papile, Abbey C. Hines, Leslie D. Wilson, Dianne E. Herron, Lucy Smiley, Kathleen A. Kennedy, Jon E. Tyson, Andrea Freeman Duncan, Allison G. Dempsey, Janice John, Patrick M. Jones, M. Layne Lillie, Saba Siddiki, Daniel K. Sperry, Mary Anne Berberich, Carol J. Blaisdell, Dorothy B. Gail, James P. Kiley, Dennis Wallace, Marie G. Gantz, Jamie E. Newman, Jeanette O'Donnell Auman, Jane A. Hammond, W. Kenneth Poole, Krisa P. Van Meurs, David K. Stevenson, Maria Elena DeAnda, M. Bethany Ball, Gabrielle T. Goodlin, Ivan D. Frantz, John M. Fiascone, Anne Furey, Brenda L. MacKinnon, Ellen Nylen, Ana Brussa, Cecelia Sibley, Waldemar A. Carlo, Namasivayam Ambalavanan, Myriam Peralta-Carcelen, Monica V. Collins, Shirley S. Cosby, Vivien A. Phillips, Kirstin J. Bailey, Fred J. Biasini, Maria Hopkins, Kristen C. Johnston, Kathleen G. Nelson, Cryshelle S. Patterson, Richard V. Rector, Leslie Rodriguez, Amanda Soong, Sally Whitley, Sheree York, Kristy Guest, Leigh Ann Smith, Neil N. Finer, Donna Garey, Maynard R. Rasmussen, Paul R. Wozniak, Yvonne E. Vaucher, Martha G. Fuller, Natacha Akshoomoff, Wade Rich, Kathy Arnell, Renee Bridge, Edward F. Bell, Tarah T. Colaizy, John A. Widness, Jonathan M. Klein, Karen J. Johnson, Michael J. Acarregui, Diane L. Eastman, Tammy L.V. Wilgenbusch, Kristi L. Watterberg, Robin K. Ohls, Janell Fuller, Jean Lowe, Julie Rohr, Conra Backstrom Lacy, Rebecca Montman, Sandra Brown, Pablo J. Sánchez, Charles R. Rosenfeld, Walid A. Salhab, Luc Brion, Sally S. Adams, James Allen, Laura Grau, Alicia Guzman, Gaynelle Hensley, Elizabeth T. Heyne, Jackie F. Hickman, Melissa H. Leps, Linda A. Madden, Melissa Martin, Nancy A. Miller, Janet S. Morgan, Araceli Solis, Lizette E. Lee, Catherine Twell Boatman, Diana M. Vasil, Bradley A. Yoder, Roger G. Faix, Sarah Winter, Shawna Baker, Karen A. Osborne, Carrie A. Rau, Sean Cunningham, Ariel Ford, Seetha Shankaran, Athina Pappas, Beena G. Sood, Rebecca Bara, Thomas L. Slovis, Elizabeth Billian, Laura A. Goldston, and Mary Johnson

Subjects
Male, Percentile, Pediatrics, medicine.medical_specialty, Waist, Neuroimaging, Overweight, Article, Body Mass Index, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, 030225 pediatrics, medicine, Humans, Obesity, 030212 general & internal medicine, Child, Schools, business.industry, Incidence, Postmenstrual Age, nutritional and metabolic diseases, Infant, Low Birth Weight, Anthropometry, Prognosis, medicine.disease, United States, Neurodevelopmental Disorders, Pediatrics, Perinatology and Child Health, Female, medicine.symptom, business, Weight gain, Body mass index, Infant, Premature
Abstract

OBJECTIVE: To identify rates of overweight (BMI ≥85(th) percentile) and obesity (BMI ≥95(th) percentile) at 6-7 years of age and associated risk factors among extremely preterm infants born at < 28 weeks of gestation. STUDY DESIGN: Anthropometrics, blood pressure, and active and sedentary activity levels were prospectively assessed. Three groups were compared, those with BMI≥85(th) percentile (overweight or obese for age, height and sex) and ≥95(th) percentile (obese) versus 85(th) percentile), central fat (waist circumference> 90(th) percentile), spent more time in sedentary activity (20.5 versus 18.2 versus 16.7 hours/week), and had either systolic and/or diastolic hypertension (24% versus 26% versus 14 %) respectively. Post discharge weight gain velocities from 36 weeks postmenstrual age (PMA) to 18 months, and 18 months to 6-7 years were independently associated with BMI ≥85(th) percentile whereas weight-gain velocity from 18 months to 6-7 years was associated with obesity. CONCLUSIONS: One in five former extremely preterm infants is overweight or obese and has central obesity at early school age. Post discharge weight gain velocities were associated with overweight and obesity. These findings suggest the obesity epidemic is spreading to the most extremely preterm infants. Trial registration ClinicalTrials.gov NCT00063063 and NCT0000

Published
2018
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