50 Studies Every Neonatologist Should Know

50 Studies Every Neonatologist Should Know presents a selection of seminal trials in neonatology, including both cornerstones of practice and frontiers in trial design. The included trials cover a broad range of care topics in neonatology, as well as important learning points in a number of dimensions. The text explores each trial in a dedicated chapter, with a concise summary of methods and results, accompanied by a brief discussion of special considerations, including risks of bias, interpretation, and implications for practice. Additionally, there is a short interview with the trialist (or an editorial commentary) at the end of each chapter, to give a flavor of the ongoing conversation after trial publication.

As with all books in the "50 Studies" series, each study was selected using an objective selection criterion that included citations per year, high levels of evidence, clinical studies and trials, and a 3-stage Delphi review by international experts in the field. It is a must-read for neonatologists, trainees, or anyone involved in neonatal care or trial design.

Susanne Hay, MD is an academic neonatologist with an interest in evidence-based care. She graduated from Harvard College and earned a medical degree from Columbia College of Physicians & Surgeons. She went on to train in pediatrics in the Boston Combined Residency Program, and then completed the Harvard Combined Fellowship in Neonatology. Dr. Hay is now an attending neonatologist at the Beth Israel Deaconess Medical Center and an instructor in pediatrics at the Harvard Medical School. Her primary research focus is data synthesis, evaluating the neonatal research landscape and how we know what we know, as well as how we might address inefficiencies.

Roger F. Soll, MD is the H. Wallace Professor of Neonatology at the University of Vermont, Vice President of the Vermont Oxford Network (VON) and Director of the VON Institute for Evidence Based Practice. He is the author of numerous peer reviewed articles and book chapters on the subject of surfactant replacement therapy and evidence-based medicine. Dr. Soll graduated from Cornell University in 1975 and received his M.D. degree from the University of Health Sciences/Chicago Medical School in 1978. He completed his residency training in Pediatrics at Bellevue Hospital/New York University Medical Center in 1981. After 2 years with the Public Health Service, Dr. Soll returned to academic training. He completed the fellowship in Neonatal Perinatal Medicine at the University of Vermont in 1985 and has remained in Vermont ever since.

Barbara Schmidt, MD, MSc is a neonatologist and clinical epidemiologist who led three large international neonatal randomized trials with clinically important, long-term outcomes: (1) Trial of Indomethacin Prophylaxis in Preterms (TIPP); (2) Caffeine for Apnea of Prematurity (CAP) Trial; and (3) Canadian Oxygen Trial (COT). Dr. Schmidt has received the highest honors in her specialty, including the Douglas K Richardson Award from the Society for Pediatric Research, the Virginia Apgar Award from the American Academy of Pediatrics, and the Arvo Ylppo¨ Medal from the Finnish Pediatric Research Foundation. She is a member of the Order of Canada.

Haresh Kirpalani, MD, MSc is a neonatologist and clinical epidemiologist. He led three large randomized trials with clinically important outcomes: (1) Nasal Intermittent Positive-Pressure Ventilation (NIPPV) (2) Transfusion of Prematures (TOP); and (3) Sustained Aeration of Infant Lungs (SAIL). He has received several prizes for teaching and mentorship, for clinical neonatology and principles of evidence based practice. He was a founding member of ‘Evidence Based Neonatology’. He has been a co-chair of the forum ‘Hot Topics for Neonatology’ for 10 years. In 2022 he was awarded the William A Silverman Lectureship Award, of the American Academy of Pediatrics.

John. Zupancic, MD, MS, ScD is Associate Professor of Pediatrics at Harvard Medical School and Associate Chief of Neonatology at Beth Israel Deaconess Medical Center, and serves as the Director of the Exploring Pathways to Optimize Child Health (EPOCH) program, which oversees neonatology clinical research at that institution. His own scholarly work seeks to improve the efficiency with which scarce resources are used in improving the health of children, and in particular, newborns. Dr. Zupancic is also involved in various epidemiologic and health services investigations, including the Neonatology Canon Project, a large-scale systematic review of all randomized controlled trials in neonatology over a thirty-year period. He was the recipient of the Massachusetts Medical Society's Henry Ingersoll Bowditch Award for Excellence in Public Health in 2020.

Preface from the Series Editor
Preface
Contributors

Intrapartum Care
1. A Controlled Trial of Antepartum Glucocorticoid Treatment for Prevention of the Respiratory Distress Syndrome in Premature Infants
Sarah D. McDonald
2. Prevention of Early-Onset Neonatal Group B Streptococcal Disease with Selective Intrapartum Chemoprophylaxis
Megan J. Turner and Clyde J. Wright
3. Reduction of Maternal-Infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment
Wes Onland and Anton H. van Kaam
4. A Randomized, Controlled Trial of Magnesium Sulfate for the Prevention of Cerebral Palsy: The BEAM Trial
Elizabeth Foglia

Resuscitation
5. Resuscitation of Asphyxiated Newborn Infants with Room Air or Oxygen: The Resair 2 Trial
Elizabeth Baker and Peter G. Davis
6. Delivery Room Management Of The Apparently Vigorous Meconium-Stained Neonate
Charles Christoph Roehr
7. Randomized Trial of Occlusive Wrap for Heat Loss Prevention in Preterm Infants: The HeLP Trial
Anup Katheria
8. Association of Umbilical Cord Milking Versus Delayed Umbilical Cord Clamping with Death or Severe Intraventricular Hemorrhage among Preterm Infants: The PREMOD2 Trial
Seh Hyun Kim and Han-Suk Kim
9. Effect of Sustained Inflations Versus Intermittent Positive Pressure Ventilation on Bronchopulmonary Dysplasia or Death among Extremely Preterm Infants: The SAIL Trial
Susanne Hay and John Zupancic

Cardiovascular
10. Effects of Indomethacin in Premature Infants with Patent Ductus Arteriosus
Souvik Mitra
11. Extracorporeal Circulation in Neonatal Respiratory Failure
Elizabeth Baker and Peter G. Davis
12. UK Collaborative Randomised Trial of Neonatal Extracorporeal Membrane Oxygenation
Brianna Liberio and Clyde J. Wright
13. Inhaled Nitric Oxide in Full-Term and Nearly Full-Term Infants with Hypoxic Respiratory Failure: The NINOS Trial
Dirk Bassler

Respiratory
14. Prevention of Neonatal Respiratory Distress Syndrome by Tracheal Instillation of Surfactant
Colm P.F. O'Donnell
15. Collaborative Quality Improvement to Promote Evidence Based Surfactant for Preterm Infants: A Cluster Randomised Trial
Ashraf Kharrat and Prakesh S. Shah
16. Pressure-Regulated Volume Control Ventilation Versus Synchronized Intermittent Mandatory Ventilation for Very Low-Birth-Weight Infants
Erik A. Jensen
17. Long-Term Effects of Caffeine Therapy for Apnea of Prematurity: The CAP Trial
Dirk Bassler
18. Outcome at Two Years of Age of Infants from The DART Study: A Multicenter, International, Randomised, Controlled Trial of Low-Dose Dexamethasone
Anton H. van Kaam and Wes Onland
19. Early CPAP Versus Surfactant in Extremely Preterm Infants: The SUPPORT Trial
Brett J. Manley
20. Target Ranges of Oxygen Saturation in Extremely Preterm Infants: The SUPPORT Trial
James I. Hagadorn
21. A Trial Comparing Noninvasive Ventilation Strategies in Preterm Infants
Brett J. Manley
22. High-Flow Nasal Cannulae in Very Preterm Infants after Extubation: The HIPERSPACE Trial
Charles Christoph Roehr

Nutrition
23. Randomised Trial of Early Diet in Preterm Babies and Later Intelligence Quotient
Michelle Fernandes and Jon Dorling
24. Vitamin A Supplementation for Extremely-Low-Birth-Weight Infants
Susanne Hay and Axel R. Franz
25. Promotion of Breastfeeding Intervention Trial: The PROBIT Trial
Nicholas D. Embleton
26. Dextrose Gel for Neonatal Hypoglycemia: The Sugar Babies Trial
Adel Mohamed, Jyotsna Shah, and Prakesh S. Shah
27. Effect of Supplemental Donor Human Milk Compared with Preterm Formula on Neurodevelopment of Very Low-Birth-Weight Infants at 18 Months: The DOMINO Trial
Nicholas D. Embleton

Thermal
28. The Influence of the Thermal Environment upon the Survival of Newly Born Premature Infants
David Osborn
29. Kangaroo Mother Versus Traditional Care for Newborn Infants.
Srinivas Murki

Infectious Disease / Immunology
30. Palivizumab, A Humanized Respiratory Syncytial Virus Monoclonal Antibody, Reduces Hospitalization from Respiratory Syncytial Virus Infection in High-Risk Infants: The IMpact-RSV Trial
Brian C. King
31. Probiotic Effects on Late-Onset Sepsis in Very Preterm Infants: The ProPrems Trial
Deena Thomas and M. Jeeva Shankar
32. Valganciclovir for Symptomatic Congenital Cytomegalovirus Disease
Li Ma

Hematology
33. Hemorrhagic Disease of the Newborn
Anna E. Curley
34. Effects of Early Erythropoietin Therapy on the Transfusion Requirements of Preterm Infants Below 1250 Grams Birth Weight
Anna E. Curley
35. Higher or Lower Hemoglobin Transfusion Thresholds for Preterm Infants: The TOP Trial
Axel R. Franz
36. A Randomized Trial of Erythropoietin for Neuroprotection in Preterm Infants: The PENUT Trial
Nicholas D. Embleton
37. Randomized Trial of Platelet-Transfusion Thresholds in Neonates: The PlaNeT Trial
Ravi Mangal Patel

Ophthalmology
38. Multicenter Trial of Cryotherapy for Retinopathy of Prematurity, Preliminary Results: The CRYO-ROP Trial
James I. Hagadorn
39. Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity, Primary Outcomes: The STOP-ROP Trial
Souvik Mitra
40. Efficacy of Intravitreal Bevacizumab for Stage 3+ Retinopathy of Prematurity: The BEAT-ROP Trial
Brian C. King

Neurology
41. Long-Term Effects of Indomethacin Prophylaxis in Extremely-Low-Birth-Weight Infants: The TIPP Trial
Peter W. Fowlie and William McGuire
42. Effects of Morphine Analgesia in Ventilated Preterm Neonates, Primary Outcomes: The NEOPAIN Trial
Souvik Mitra
43. Whole-Body Hypothermia for Neonates with Hypoxic-Ischemic Encephalopathy
Anton H. van Kaam and Wes Onland
44. Effectiveness of Sucrose Analgesia in Newborns Undergoing Painful Medical Procedures
David Osborn
45. A Randomized Trial of Prenatal Versus Postnatal Repair of Myelomeningocele: The MOMS Trial
Sara DeMauro
46. Neurodevelopmental Outcome at Five Years of Age after General Anaesthesia or Awake-Regional Anaesthesia In Infancy: The GAS Trial
Sara B. DeMauro
47. Levetiracetam Versus Phenobarbital for Neonatal Seizures: The NEOLEV2 Trial
Stefan Johansson
48. Hypothermia for Moderate or Severe Neonatal Encephalopathy in Low-Income and Middle-Income Countries: The HELIX Trial
Srinivas Murki

Health Services
49. Newborn-Care Training and Perinatal Mortality in Developing Countries: The First Breath Trial
Danielle E.Y. Ehret
50. Effectiveness of Family Integrated Care in Neonatal Intensive Care Units on Infant and Parent Outcomes
Evangelia Myttaraki and Chris Gale