Browsing by Author "Cogen, Martin S."

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    Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
    (Springer Nature, 2021) Adams-Chapman, Ira; Watterberg, Kristi L.; Nolen, Tracy L.; Hirsch, Shawn; Cole, Carol A.; Cotten, C. Michael; Oh, William; Poindexter, Brenda B.; Zaterka-Baxter, Kristin M.; Das, Abhik; Backstrom Lacy, Conra; Scorsone, Ann Marie; Duncan, Andrea F.; DeMauro, Sara B.; Goldstein, Ricki F.; Colaizy, Tarah T.; Wilson-Costello, Deanne E.; Purdy, Isabell B.; Hintz, Susan R.; Heyne, Roy J.; Myers, Gary J.; Fuller, Janell; Merhar, Stephanie; Harmon, Heidi M.; Peralta-Carcelen, Myriam; Kilbride, Howard W.; Maitre, Nathalie L.; Vohr, Betty R.; Natarajan, Girija; Mintz-Hittner, Helen; Quinn, Graham E.; Wallace, David K.; Olson, Richard J.; Orge, Faruk H.; Tsui, Irena; Gaynon, Michael; Hutchinson, Amy K.; He, Yu-Guang; Winter, Timothy W.; Yang, Michael B.; Haider, Kathryn M.; Cogen, Martin S.; Hug, Denise; Bremer, Don L.; Donahue, John P.; Lucas, William R.; Phelps, Dale L.; Higgins, Rosemary D.; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network; Pediatrics, School of Medicine
    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.