Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial

Ira Adams-Chapman, Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA
Kristi L. Watterberg, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
Tracy L. Nolen, Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA
Shawn Hirsch, Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA
Carol A. Cole, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
C Michael Cotten, Department of Pediatrics, Duke University, Durham, NC, USA
William Oh, Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA
Brenda B. Poindexter, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA; Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA
Kristin M. Zaterka-Baxter, Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USA
Abhik Das, Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USA
Conra Backstrom Lacy, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
Ann Marie Scorsone, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Andrea F. Duncan, Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA
Sara B. DeMauro, Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA
Ricki F. Goldstein, Department of Pediatrics, Duke University, Durham, NC, USA
Tarah T. Colaizy, Department of Pediatrics, University of Iowa, Iowa City, IA, USA
Deanne E. Wilson-Costello, Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA
Isabell B. Purdy, Department of Pediatrics, University of California, Los Angeles, CA, USA
Susan R. Hintz, Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA
Roy J. Heyne, Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA
Gary J. Myers, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Janell Fuller, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
Stephanie Merhar, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA
Heidi M. Harmon, Department of Pediatrics, University of Iowa, Iowa City, IA, USA; Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA
Myriam Peralta-Carcelen, Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA
Howard W. Kilbride, Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA
Nathalie L. Maitre, Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USA
Betty R. Vohr, Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USA
Girija Natarajan, Department of Pediatrics, Wayne State University, Detroit, MI, USA
Helen Mintz-Hittner, Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA
Graham E. Quinn, Department of Ophthalmology, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA
David K. Wallace, Department of Ophthalmology, Duke University, Durham, NC, USA; Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
Richard J. Olson, Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USA
Faruk H. Orge, Department of Ophthalmology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA
Irena Tsui, Department of Ophthalmology, University of California, Los Angeles, CA, USA
Michael Gaynon, Department of Ophthalmology, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA
Amy K. Hutchinson, Department of Ophthalmology, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA
Yu-Guang He, Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA
Timothy W. Winter, Division of Ophthalmology/Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USA
Michael B. Yang, Department of Ophthalmology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA
Kathryn M. Haider, Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USA
Martin S. Cogen, Department of Ophthalmology, University of Alabama at Birmingham, Birmingham, AL, USA
Denise Hug, Department of Ophthalmology, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USA
Don L. Bremer, Department of Ophthalmology, Nationwide Children's Hospital, Columbus, OH, USA
John P. Donahue, Alpert Medical School of Brown University and Consulting Staff, Women & Infants Hospital of Rhode Island, Providence, RI, USA
William R. Lucas, Department of Ophthalmology, Wayne State University, Detroit, MI, USA
Dale L. Phelps, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA
Rosemary D Higgins, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA. rhiggin@gmu.edu; College of Health and Human Services, George Mason University, Fairfax, VA, USA
Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network

Document Type

Article

Publication Date

8-1-2021

Abstract

OBJECTIVE: This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.

STUDY DESIGN: Bayley Scales of Infants Development-III and a standardized neurosensory examination were performed in infants enrolled in the main trial. Moderate/severe NDI was defined as BSID-III Cognitive or Motor composite score

RESULTS: Primary outcome was determined for 605/638 (95%). The mean gestational age was 25.8 ± 1.3 weeks and mean birthweight was 805 ± 192 g. Treatment group did not affect the risk for the composite outcome of death or survival with moderate/severe NDI (60% vs 56%, p = 0.40).

CONCLUSIONS: Treatment group did not affect the risk of death or survival with moderate/severe NDI. Despite early termination, this study represents the largest RCT of extremely preterm infants treated with myo-inositol with neurodevelopmental outcome data.

Publication Title

Journal of perinatology : official journal of the California Perinatal Association

ISSN

1476-5543

Volume

41

Issue

8

First Page

2072

Last Page

2087

DOI

10.1038/s41372-021-01018-5

Comments

  • PMCID: PMC8349854 (available on 2022-08-01)

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