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Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial
Adams-Chapman, I., Watterberg, K. L., Nolen, T. L., Hirsch, S., Cole, C. A., Cotten, C. M., Oh, W., Poindexter, B. B., Zaterka-Baxter, K. M., Das, A., Lacy, C. B., Scorsone, A. M., Duncan, A. F., DeMauro, S. B., Goldstein, R. F., Colaizy, T. T., Wilson-Costello, D. E., Purdy, I. B., Hintz, S. R., ... Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network (2021). Neurodevelopmental outcome of preterm infants enrolled in myo-inositol randomized controlled trial. Journal of Perinatology, 41(8), 2072-2087. https://doi.org/10.1038/s41372-021-01018-5
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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