Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

NCT06679972 | Enrolling By Invitation

• 1 other identifier: 34/15.10.2024
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Intrahepatic cholestasis of pregnancy is a liver condition in late pregnancy, causing itching and high bile acid levels that return to normal after birth. Babies born to mothers with this condition may have a higher risk of breathing issues. Researchers suspect bile acids might lead to a specific type of lung problem in newborns, but more studies are needed to confirm this.

Conditions

Intrahepatic Cholestasis of Pregnancy; Respiratory Distress Syndrome, Newborn

Keywords

bile-acid pneumonia; cholestasis of pregnancy; intrahepatic cholestasis; RDS; respiratory distress syndrome

Outcome Measures

Primary Outcomes (3)

• Incidence of respiratory distress syndrome

  RDS is defined as a clinical diagnosis made within the first 72 hours of life, based on signs of respiratory compromise (tachypnea, grunting, nasal flaring, chest retractions), supportive radiographic findings and a need for supplemental oxygen or respiratory support.

  First 72 hours of life

• The need for exogenous surfactant administration

  Surfactant administration refers to any administration of exogenous surfactant therapy within the first 72 hours of life, regardless of dosing or mode of delivery.

  First 72 hours of life

• Biomarkers related to pulmonary injury and surfactant deficiency

  This trial seeks to determine whether neonates exposed to intrahepatic cholestasis of pregnancy exhibit distinct serum biomarker profiles consistent with lung injury and surfactant impairment, compared to those of similar gestational age/birthweight/sex born to mothers with no liver disease.

  In the first 24 hours, at 48-72 hours and at 7 days of life

Secondary Outcomes (4)

• Respiratory morbidity

  First 7 days of life

• NICU admission

  First 48-72 hours of life

• Length of hospitalization

  From day 1 of life until discharge

• Neonatal mortality

  From day 1 of life until 28 days of life

Study Arms (2)

ICP-Exposed Group

This group will include all neonates born to mothers with intrahepatic cholestasis of pregnancy.

Unexposed Group

This group will include neonates born to mothers without a known history of hepatic disease prior to or during the index pregnancy. Controls will be matched according to gestational age at birth, birthweight and sex.

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study will include selected neonates born at term or preterm age, in a third degree neonatal unit in Bucharest, Romania (Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu"). For the ICP-exposed group, the study population is represented by neonates born to mothers with intrahepatic cholestasis diagnosed during pregnancy. The unexposed group will include neonates of similar gestational age/weight/sex at birth born to mothers with no hepatic diseases.

You may qualify if:

• mother with recent diagnosis of intrahepatic cholestasis of pregnancy (serum bile acids over 10 micromol/l in the last 7 days before birth), with informed consent given a few hours before giving birth
• ursodeoxycholic acid, independent of dosage or initiation of treatment
• neonates born in Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu" or transferred to our unit in the first 24 hours of life

You may not qualify if:

• no informed consent
• serum bile acids under 10 micromol/l in the last 7 days before birth
• newborns transferred from other neonatal units after 24 hours of life
• UNEXPOSED GROUP
• mother with no history of hepatic disease during or before the current pregnancy, with informed consent given a few hours before giving birth
• neonates born in Clinical Hospital of Obstetrics and Gynecology "Prof.Dr. Panait Sirbu", of similar gestational age/weight/sex at birth to corresponding neonates in the ICP-exposed group
• \- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu"

Bucharest, Bucharest, 060251, Romania

Location

Related Publications (1)

• Niculae LE, Niculae AS, Tocariu R, Petca A. Impact of intrahepatic cholestasis of pregnancy on neonatal respiratory outcomes (CHOLE-RESP): protocol for a prospective cohort study. Front Pediatr. 2026 Feb 2;14:1640579. doi: 10.3389/fped.2026.1640579. eCollection 2026.

  PMID: 41704598 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum extracted after centrifugation, frozen at minus 50 degrees Celsius

MeSH Terms

Conditions

Intrahepatic Cholestasis of Pregnancy; Respiratory Distress Syndrome, Newborn; Cholestasis, Intrahepatic; Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Student, Medical Resident Neonatologist

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 8, 2024
• Study Start: October 28, 2024
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)