Characterizing Infants in the Sentinel Distributed Database Mother-Infant Linkage Table

The U.S. Food and Drug Administration's Sentinel Distributed Database (SDD) includes a Mother-Infant Linkage (MIL) table, allowing assessment of prenatal, mother, and infant outcomes.

This poster characterizes demographics, enrollment, medication use, immunizations, health conditions, and major congenital malformations (MCMs) of infants in the SDD MIL table, comparing infants paired to a mother to those not in such a pair. It was presented at the 2024 ISPE Annual Meeting.