# Impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes (CHOLE-RESP): protocol for a prospective cohort study

## TL;DR

This study investigates how intrahepatic cholestasis of pregnancy affects newborns' respiratory health through a detailed analysis of biomarkers and clinical outcomes.

## Contribution

The study introduces a novel prospective cohort design to explore the link between maternal cholestasis and neonatal respiratory distress.

## Key findings

- Neonates exposed to maternal cholestasis may show higher rates of respiratory distress syndrome.
- Biomarker profiles suggest pulmonary compromise in ICP-exposed neonates.
- The study could inform early risk stratification for affected newborns.

## Abstract

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.

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.

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.

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).