by
Sheena Carter;
Amy Hutchinson;
Salathiel Kendrick-Allwood;
Nathalie Maitre;
Ira Adams-Chapman;
Kristi L Watterberg;
Tracy L Nolen;
Shawn Hirsch;
Carol A Cole;
Michael C Cotten;
William Oh;
Brenda Poindexter;
KM Zaterka-Baxter;
A Das;
CB Lacy;
AM Scorsone;
AF Duncan;
SB DeMauro;
RF Goldstein;
TT Colaizy;
DE Wilson-Costello;
IB Purdy;
SR Hintz;
RJ Heyne;
GJ Myers;
J Fuller;
S Merhar;
HM Harmon;
M Peralta-Carcelen;
HW Kilbride;
BR Vohr;
G Natarajan;
H Mintz-Hittner;
GE Quinn;
DK Wallace;
RJ Olson;
FH Orge;
I Tsui;
M Gaynon;
Y-G He;
TW Winter;
MB Yang;
KM Haider;
MS Cogen;
D Hug;
DL Bremer;
JP Donahue;
WR Lucas;
DL Phelps;
RD Higgins
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.