Neonatal Encephalopathy following SSRI exposure in utero: The NESSRI study
Marie-Coralie Cornet, MD
BACKGROUND: Around 1 in 20 women in the United States are treated with selective serotonin reuptake inhibitor (SSRI) during pregnancy. Recent studies suggest that fetuses exposed to SSRI in utero may be at higher risks of neonatal encephalopathy. GAP: No population-based studies have described the frequency of encephalopathy in neonates exposed to SSRI. Furthermore, the neuroprotective impact of therapeutic hypothermia, a proven treatment for hypoxic-ischemic encephalopathy (HIE), among neonates with SSRI-induced encephalopathy is unknown. HYPOTHESIS: The risk of neonatal encephalopathy due to SSRI exposure is a) independent of maternal depression, b) dose-dependent, and c) higher in newborns exposed during the third trimester of gestation. Furthermore, among neonates with encephalopathy who receive therapeutic hypothermia, exposure to SSRI correlates with milder encephalopathy and less evidence of acute injury on brain MRI. METHODS: This is a large population-based cohort study comprising 293,022 infants born at 36 weeks gestational age within Kaiser Permanente Northern California hospitals between January 2012 and August 2019 and includes about 850 neonates with encephalopathy. Individual-level data on SSRI exposure including dose and duration, Apgar scores, acidosis, need for resuscitation, presence and degree of encephalopathy, and neonatal diagnosis will be available. RESULTS: Pending. IMPACT: This study will inform parents and providers of the risk of neonatal encephalopathy following SSRI exposure and the effects of dosage and timing. We will determine if clinical and biological signs can differentiate encephalopathy due to SSRI exposure from encephalopathy due to HIE. Quantification of the risks associated with SSRIs will inform physician and patient choices regarding SSRIs vs. non-pharmacological treatments of maternal depression.