Neonatal Safety Information Reported to the FDA During Drug Development Studies.

Background: Relatively few neonatal drug development studies have been conducted, but an increase is expected with the enactment of the Food and Drug Administration Safety and Innovation Act (FDASIA). Understanding the safety of drugs studied in neonates is complicated by the unique nature of the population and the level of illness. The objective of this study was to examine neonatal safety data submitted to the FDA in studies pursuant to the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) between 1998 and 2015.

Resting heart rate does not predict growth in preterm infants.

Background: Previous reports indicate that preterm infants with higher baseline heart rate (HR) have greater weight gain than preterm infants with lower baseline HR. To verify this correlation and the potential utility of resting HR as a bench mark for risk of extrauterine growth restriction (EUGR), we studied preterm infants born between 32 and 36weeks gestation. Earlier gestation infants (27 to 31weeks) were included.