Frontiers in pediatrics · 2026
Impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes (CHOLE-RESP): protocol for a prospective cohort study.
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Niculae Lucia Elena, Niculae Alexandru Stefan, Tocariu Raluca, Petca Aida
Аннотация
BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is the most common liver disorder unique to pregnancy, associated with elevated maternal bile acid concentrations and adverse perinatal outcomes.
METHODS: This is a prospective cohort study conducted in a level III neonatal unit in Bucharest, Romania. Neonates born to mothers with ICP (serum bile acids ≥10 μmol/L within seven days before delivery) will be enrolled alongside gestational age, sex and birthweight-matched controls. Serum samples will be collected at 24 h, 48-72 h and on day 7 of life. Quantitative ELISA kits will be used to assess serum biomarkers associated with surfactant dysfunction and lung injury. Perinatal and clinical outcomes will be recorded systematically.
RESULTS: The primary aims are to compare the incidence of respiratory distress syndrome (RDS), the need for surfactant administration and serum biomarker profiles between ICP-exposed and unexposed neonates. Secondary aims include evaluating respiratory support requirements, neonatal morbidity and mortality across groups.
CONCLUSIONS: We expect that neonates exposed to maternal cholestasis will have a higher incidence of RDS, increased surfactant need, and biomarker alterations consistent with pulmonary compromise. This study may improve understanding of bile acid-related lung injury and inform early risk stratification strategies in affected newborns. (NCT06679972).
METHODS: This is a prospective cohort study conducted in a level III neonatal unit in Bucharest, Romania. Neonates born to mothers with ICP (serum bile acids ≥10 μmol/L within seven days before delivery) will be enrolled alongside gestational age, sex and birthweight-matched controls. Serum samples will be collected at 24 h, 48-72 h and on day 7 of life. Quantitative ELISA kits will be used to assess serum biomarkers associated with surfactant dysfunction and lung injury. Perinatal and clinical outcomes will be recorded systematically.
RESULTS: The primary aims are to compare the incidence of respiratory distress syndrome (RDS), the need for surfactant administration and serum biomarker profiles between ICP-exposed and unexposed neonates. Secondary aims include evaluating respiratory support requirements, neonatal morbidity and mortality across groups.
CONCLUSIONS: We expect that neonates exposed to maternal cholestasis will have a higher incidence of RDS, increased surfactant need, and biomarker alterations consistent with pulmonary compromise. This study may improve understanding of bile acid-related lung injury and inform early risk stratification strategies in affected newborns. (NCT06679972).