Study Population
hemoglobinopathy
PREMATURE BIRTH, HEMOGLOBINOPATHY, SECONDARY, CYANOTIC CONGENITAL HEART DISEASE, CONGENITAL ANEMIA, ISOIMMUNE HEMOLYTIC DISEASE
The trial protocol is in Infants were eligible for the observational secondary study of NIRS monitoring between August 1, 2015, and April 12, 2017, if they were concurrently enrolled in the TOP trial. Parental informed consent was sought unless skin integrity was deemed inadequate for NIRS sensor placement for the duration of the infant’s enrollment in the trial or if any TOP exclusion criteria were present (cyanotic congenital heart disease, nonviability as deemed by attending neonatologist, in utero fetal transfusion, twin-to-twin transfusion syndrome, isoimmune hemolytic disease, congenital condition other than premature birth that adversely affects life expectancy or neurodevelopment, parents opposed to the transfusion of blood, parents with hemoglobinopathy or congenital anemia, prior blood transfusion beyond the first 6 hours of life, or high probability that the family would not be able to return for follow-up at 22-26 months). Institutional review board approval was obtained at each site, and multisite training was conducted prior to study enrollment. The study followed the Strengthening the Reporting of Observational Studies in Epidemiology (