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

Ira Adams-Chapman; Kristi L. Watterberg; Tracy L. Nolen; Shawn Hirsch; Carol A. Cole; C. Michael Cotten; William Oh; Brenda B. Poindexter; Kristin M. Zaterka-Baxter; Abhik Das; Conra Backstrom Lacy; Ann Marie Scorsone; Andrea F. Duncan; Sara B. DeMauro; Ricki F. Goldstein; Tarah T. Colaizy; Deanne E. Wilson-Costello; Isabell B. Purdy; Susan R. Hintz; Roy J. Heyne; Gary J. Myers; Janell Fuller; Stephanie Merhar; Heidi M. Harmon; Myriam Peralta-Carcelen; Howard W. Kilbride; Nathalie L. Maitre; Betty R. Vohr; Girija Natarajan; Helen Mintz-Hittner; Graham E. Quinn; David K. Wallace; Richard J. Olson; Faruk H. Orge; Irena Tsui; Michael Gaynon; Amy K. Hutchinson; Yu-Guang He; Timothy W. Winter; Michael B. Yang; Kathryn M. Haider; Martin S. Cogen; Denise Hug; Don L. Bremer; John P. Donahue; William R. Lucas; Dale L. Phelps; Rosemary D. Higgins; Eunice Kennedy Shriver Natl Inst C

doi:10.1038/s41372-021-01018-5

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

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

Ira Adams-Chapman, Kristi L. Watterberg, Tracy L. Nolen, Shawn Hirsch, Carol A. Cole, C. Michael Cotten, William Oh, Brenda B. Poindexter, Kristin M. Zaterka-Baxter, Abhik Das, …

Journal of perinatology, Vol.41(8), pp.2072-2087

08-01-2021

DOI: https://doi.org/10.1038/s41372-021-01018-5

PMID: 33758387

Abstract

Life Sciences & Biomedicine

Obstetrics & Gynecology

Pediatrics

Science & Technology

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 <85, moderate or severe cerebral palsy, blindness, or hearing loss that prevents communication despite amplification were assessed. 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.

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Title: Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
Creators: Ira Adams-Chapman - Emory University
Kristi L. Watterberg - University of New Mexico
Tracy L. Nolen - RTI International
Shawn Hirsch - RTI International
Carol A. Cole - University of Rochester
C. Michael Cotten - Duke University
William Oh - Brown University
Brenda B. Poindexter - Cincinnati Children's Hospital Medical Center
Kristin M. Zaterka-Baxter - RTI International
Abhik Das - RTI International
Conra Backstrom Lacy - University of New Mexico
Ann Marie Scorsone - University of Rochester
Andrea F. Duncan - The University of Texas Health Science Center at Houston
Sara B. DeMauro - University of Pennsylvania
Ricki F. Goldstein - Duke University
Tarah T. Colaizy - University of Iowa
Deanne E. Wilson-Costello - Case Western Reserve University
Isabell B. Purdy - University of California, Los Angeles
Susan R. Hintz - Stanford University
Roy J. Heyne - The University of Texas Southwestern Medical Center
Gary J. Myers - University of Rochester
Janell Fuller - University of New Mexico
Stephanie Merhar - University of Cincinnati
Heidi M. Harmon - Indiana University – Purdue University Indianapolis
Myriam Peralta-Carcelen - University of Alabama at Birmingham
Howard W. Kilbride - University of Missouri–Kansas City
Nathalie L. Maitre - Nationwide Children's Hospital
Betty R. Vohr - Brown University
Girija Natarajan - Wayne State University
Helen Mintz-Hittner - The University of Texas Health Science Center at Houston
Graham E. Quinn - University of Pennsylvania
David K. Wallace - Duke University
Richard J. Olson - University of Iowa
Faruk H. Orge - Case Western Reserve University
Irena Tsui - University of California, Los Angeles
Michael Gaynon - Stanford University
Amy K. Hutchinson - Children's Healthcare of Atlanta
Yu-Guang He - The University of Texas Southwestern Medical Center
Timothy W. Winter - University of New Mexico
Michael B. Yang - University of Cincinnati
Kathryn M. Haider - Indiana University – Purdue University Indianapolis
Martin S. Cogen - University of Alabama at Birmingham
Denise Hug - University of Missouri–Kansas City
Don L. Bremer - Nationwide Children's Hospital
John P. Donahue - Brown University
William R. Lucas - Wayne State University
Dale L. Phelps - University of Rochester
Rosemary D. Higgins - Eunice Kennedy Shriver National Institute of Child Health and Human Development
Eunice Kennedy Shriver Natl Inst C
Publication Details: Journal of perinatology, Vol.41(8), pp.2072-2087
Publisher: Springer Nature; LONDON
Number of pages: 16
Grant note: UL1 TR41; UL1 TR42; UL1 TR77; UL1 TR93; UL1 TR442; UL1 TR454; UL1 TR1117 / National Center for Advancing Translational Sciences; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Center for Advancing Translational Sciences (NCATS) National Institutes of Health; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA National Eye Institute; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Eye Institute (NEI) U10 HD36790; UG1 HD27904; UG1 HD21364; UG1 HD68284; UG1 HD27853; UG1 HD40492; UG1 HD27851; UG1 HD27856; UG1 HD87229; UG1 HD68278; UG1 HD27880; UG1 HD34216; UG1 HD68270; UG1 HD53109; UG1 HD53089; UG1 HD68244; UG1 HD68263; UG1 HD40689; UG1 HD21385 / Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Identifiers: 99385550123106570
Academic Unit: Office of Research & Sponsored Programs
Language: English
Resource Type: Journal article

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

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