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

Background: 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.

Objectives: This study aims to characterize 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.

Methods: Data from January 1, 2000, to December 31, 2022, were analyzed for 22,820,930 infants, of which 23.8% were paired to a mother. Health characteristics were described for paired infants by searching both mother's and infant's records and infant's records alone. Characteristics were studied within the first 28 days and up to 365 days after birth, utilizing the SDD MIL with data from Medicaid and other health plans (56% from Medicaid).

Results: About 49% of 22,820,930 infants in the SDD MIL data were female, with 64% having over one year of continuous enrollment. About 38% of infants from Medicaid data had unknown race/ethnicity compared to 93% in non-Medicaid data.
Infants in a mother-infant pair had slightly different characteristics in the first 28 days but were generally similar to unpaired infants. Allergies and low birth weight (LBW) were the most common health conditions in Medicaid in both paired and unpaired infants; while in non-Medicaid data, gastroesophageal reflux disease and LBW were the most common. The prevalence of health characteristics, such as LBW, increased when the mother’s record was added in both Medicaid and non-Medicaid data.
After the first month, infants with a paired mother in both Medicaid and non-Medicaid data had more medication dispensings such as antibiotics and glucocorticoids. Common health conditions, including allergies, asthma, otitis, and sinusitis, also showed higher prevalence in paired infants. Immunization rates for 12 assessed childhood vaccines were generally lower in Medicaid data compared to non-Medicaid.
In both Medicaid and non-Medicaid data, the prevalence of MCMs recorded in the first year were relatively similar, regardless of the pairing status.

Conclusions: Using data from MIL tables for both Medicaid and non-Medicaid in the SDD, we characterized 5.4 million infants with matched mothers and 17.4 million without matches. These infants were relatively similar during the first 28 days of life but showed differences in several key health indicators after the neonatal period. We observed some variations in the health characteristics of infants in Medicaid data and those in non-Medicaid data. Where available, adding the mother's record to searches considerably increased the capture of some elements while having minimal effect on others.