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

Authors

• 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. [email protected]; 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

Recommended Citation

Adams-Chapman I, Watterberg KL, Nolen TL, Hirsch S, Cole CA, Cotten CM, Oh W, Poindexter BB, Zaterka-Baxter KM, Das A, Lacy CB, Scorsone AM, Duncan AF, DeMauro SB, Goldstein RF, Colaizy TT, Wilson-Costello DE, Purdy IB, Hintz SR, Heyne RJ, Myers GJ, Fuller J, Merhar S, Harmon HM, Peralta-Carcelen M, Kilbride HW, Maitre NL, Vohr BR, Natarajan G, Mintz-Hittner H, Quinn GE, Wallace DK, Olson RJ, Orge FH, Tsui I, Gaynon M, Hutchinson AK, He YG, Winter TW, Yang MB, Haider KM, Cogen MS, Hug D, Bremer DL, Donahue JP, Lucas WR, Phelps DL, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial. J Perinatol. 2021 Aug;41(8):2072-2087. doi: 10.1038/s41372-021-01018-5. Epub 2021 Mar 23. PMID: 33758387; PMCID: PMC8349854.

Comments

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