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Enrolling by Invitation

NCT Number: NCT06679972

Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes

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.

Enrolling by Invitation

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Key information

Conditions

Intrahepatic Cholestasis of Pregnancy Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Liver Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Respiratory Tract Diseases

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bucharest, 060251, Romania

About this study

Intrahepatic cholestasis of pregnancy is a hepatic complication that predominantly arises during the second or third trimester. It is characterized by serum bile acid levels above 10 micromol/L and persistent pruritus, which resolves after delivery. To date, it has been observed that respiratory distress syndrome occurs more frequently in neonates born to mothers with cholestasis of pregnancy, and a potential new entity, 'acute bile acid-induced pneumonia,' has been proposed, though statistical confirmation is lacking. Therefore, the investigators deem it imperative to conduct a study in the neonatal population to establish a definitive conclusion regarding neonatal pulmonary impairment secondary to maternal bile acid accumulation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

ICP-EXPOSED GROUP

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Inclusion criteria

  • 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

Exclusion criteria

  • ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)

Treatment and study plan

Primary outcomes

  1. Incidence of respiratory distress syndrome

    Time frame: First 72 hours of life

    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.

  2. The need for exogenous surfactant administration

    Time frame: First 72 hours of life

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

  3. Biomarkers related to pulmonary injury and surfactant deficiency

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

    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.

Secondary outcomes

  1. Respiratory morbidity

    Time frame: First 7 days of life

    This includes the need for mechanical ventilation and non-invasive respiratory support, as well as the occurrence of serious respiratory complications including pneumothorax, pulmonary hemorrhage and persistent pulmonary hypertension.

  2. NICU admission

    Time frame: First 48-72 hours of life

  3. Length of hospitalization

    Time frame: From day 1 of life until discharge

  4. Neonatal mortality

    Time frame: From day 1 of life until 28 days of life

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)

Acronym: CHOLE-RESP

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 8, 2024
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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