Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial.
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.
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, Y-G; 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,
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