Journal article
Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
Journal of perinatology, Vol.41(8), pp.2072-2087
03/23/2021
DOI: 10.1038/s41372-021-01018-5
PMCID: PMC8349854
PMID: 33758387
Abstract
This study evaluates the 24-month follow-up for the NICHD Neonatal Research Network (NRN) Inositol for Retinopathy Trial.
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.
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).
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.
Details
- Title: Subtitle
- Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
- Creators
- Ira Adams-Chapman - Department of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USATarah T Colaizy - Department of Pediatrics, University of Iowa, Iowa City, IA, USAKristi L Watterberg - University of New Mexico Health Sciences Center, Albuquerque, NM, USAHeidi M Harmon - Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USATracy L Nolen - Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USARichard J Olson - Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, IA, USAShawn Hirsch - Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USACarol A Cole - University of Rochester School of Medicine and Dentistry, Rochester, NY, USAC Michael Cotten - Department of Pediatrics, Duke University, Durham, NC, USAWilliam Oh - Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USABrenda B Poindexter - Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USAKristin M Zaterka-Baxter - Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, North Carolina, NC, USAAbhik Das - Social, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USAConra Backstrom Lacy - University of New Mexico Health Sciences Center, Albuquerque, NM, USAAnn Marie Scorsone - University of Rochester School of Medicine and Dentistry, Rochester, NY, USAAndrea F Duncan - Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USASara B DeMauro - Department of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USARicki F Goldstein - Department of Pediatrics, Duke University, Durham, NC, USADeanne E Wilson-Costello - Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USASusan 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, USAIsabell B Purdy - Department of Pediatrics, University of California, Los Angeles, CA, USARoy J Heyne - Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USAGary J Myers - University of Rochester School of Medicine and Dentistry, Rochester, NY, USAJanell Fuller - University of New Mexico Health Sciences Center, Albuquerque, NM, USAStephanie Merhar - Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USAMyriam Peralta-Carcelen - Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USAHoward W Kilbride - Department of Pediatrics, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USANathalie L Maitre - Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH, USABetty R Vohr - Department of Pediatrics, Women & Infants' Hospital, Brown University, Providence, RI, USAGirija Natarajan - Department of Pediatrics, Wayne State University, Detroit, MI, USAHelen Mintz-Hittner - Department of Ophthalmology and Visual Science, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USAGraham E Quinn - Department of Ophthalmology, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USADavid K Wallace - Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USAFaruk H Orge - Department of Ophthalmology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USAIrena Tsui - Department of Ophthalmology, University of California, Los Angeles, CA, USAMichael Gaynon - Department of Ophthalmology, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USAAmy K Hutchinson - Emory UniversityYu-Guang He - Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USATimothy W Winter - Division of Ophthalmology/Department of Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM, USAMichael B Yang - Department of Ophthalmology, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USAKathryn M Haider - Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, IN, USAMartin S Cogen - Department of Ophthalmology, University of Alabama at Birmingham, Birmingham, AL, USADenise Hug - Department of Ophthalmology, Children's Mercy Hospital and University of Missouri Kansas City School of Medicine, Kansas City, MO, USADon L Bremer - Department of Ophthalmology, Nationwide Children's Hospital, Columbus, OH, USAJohn P Donahue - Alpert Medical School of Brown University and Consulting Staff, Women & Infants Hospital of Rhode Island, Providence, RI, USAWilliam R Lucas - Department of Ophthalmology, Wayne State University, Detroit, MI, USADale L Phelps - University of Rochester School of Medicine and Dentistry, Rochester, NY, USARosemary D Higgins - College of Health and Human Services, George Mason University, Fairfax, VA, USA. rhiggin@gmu.eduEunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
- Resource Type
- Journal article
- Publication Details
- Journal of perinatology, Vol.41(8), pp.2072-2087
- DOI
- 10.1038/s41372-021-01018-5
- PMID
- 33758387
- PMCID
- PMC8349854
- NLM abbreviation
- J Perinatol
- ISSN
- 0743-8346
- eISSN
- 1476-5543
- Grant note
- UG1 HD27904 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD68244 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UL! TR1117 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UL1 TR77 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UG1 HD21385 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UL1 TR1117 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UG1 HD27853 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD68284 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD34216 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD68263 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD53089 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UL1 TR454 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UG1 HD40492 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UL1 TR93 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UL1 TR41 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UG1 HD40689 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UG1 HD27851 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) UL1 TR42 / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) UG1 HD27880 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) U10 HD36790 / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Language
- English
- Date published
- 03/23/2021
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology; Ophthalmology and Visual Sciences
- Record Identifier
- 9984101614002771
Metrics
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