CPQCC Publication
| Title | Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial. |
| Publication Type | Journal Article |
| Year of Publication | 2021 |
| Authors | Adams-Chapman I, Watterberg KL, Nolen TL, Hirsch S, Cole CA, C Cotten M, Oh W, Poindexter BB, Zaterka-Baxter KM, Das A, Lacy CBackstrom, Scorsone AMarie, 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 Y-G, Winter TW, Yang MB, Haider KM, Cogen MS, Hug D, Bremer DL, Donahue JP, Lucas WR, Phelps DL, Higgins RD |
| Corporate Authors | Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network |
| Journal | J Perinatol |
| Volume | 41 |
| Issue | 8 |
| Pagination | 2072-2087 |
| Date Published | 2021 08 |
| ISSN | 1476-5543 |
| Keywords | Cerebral Palsy, Child Development, Gestational Age, Humans, Infant, Extremely Premature, Infant, Newborn, Inositol |
| 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 <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. |
| DOI | 10.1038/s41372-021-01018-5 |
| Alternate Journal | J Perinatol |
| PubMed ID | 33758387 |
| PubMed Central ID | PMC8349854 |
| Grant List | UG1 HD68244 / / 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) / UG1 HD21385 / / 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) / UG1 HD068270 / HD / NICHD NIH HHS / United States UG1 HD53089 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UL1 TR41 / / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) / UG1 HD34216 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UG1 HD027856 / HD / NICHD NIH HHS / United States UG1 HD034216 / HD / NICHD NIH HHS / United States UG1 HD027904 / HD / NICHD NIH HHS / United States UG1 HD053109 / HD / NICHD NIH HHS / United States U10 HD036790 / HD / NICHD NIH HHS / United States UG1 HD068278 / HD / NICHD NIH HHS / United States UG1 HD27880 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UG1 HD068263 / HD / NICHD NIH HHS / United States UG1 HD068244 / HD / NICHD NIH HHS / United States UG1 HD027853 / HD / NICHD NIH HHS / United States UL1 TR77 / / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) / UL1 TR000042 / TR / NCATS NIH HHS / United States UG1 HD087229 / HD / NICHD NIH HHS / United States UG1 HD68284 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UG1 HD040689 / HD / NICHD NIH HHS / United States UG1 HD053089 / HD / NICHD NIH HHS / United States UL1 TR000093 / TR / NCATS NIH HHS / United States UL1 TR000442 / TR / NCATS NIH HHS / United States UG1 HD27904 / / 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) / UL1 TR000454 / TR / NCATS NIH HHS / United States UL1 TR000041 / TR / NCATS NIH HHS / United States UG1 HD068284 / HD / NICHD NIH HHS / United States UL1 TR454 / / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) / UG1 HD021385 / HD / NICHD NIH HHS / United States UG1 HD040492 / HD / NICHD NIH HHS / United States UG1 HD021364 / HD / NICHD NIH HHS / United States UG1 HD027880 / HD / NICHD NIH HHS / United States UL1 TR42 / / U.S. Department of Health & Human Services | NIH | National Center for Advancing Translational Sciences (NCATS) / UL1 TR001117 / TR / NCATS NIH HHS / United States UL1 TR000077 / TR / NCATS NIH HHS / United States UG1 HD027851 / HD / NICHD NIH HHS / United States UG1 HD40689 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UG1 HD27853 / / 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) / UG1 HD68263 / / U.S. Department of Health & Human Services | NIH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) / UG1 HD40492 / / 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) / |
