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Could bile acids cause baby lung issues? new study investigates

NCT ID NCT06679972

Knowledge-focused Sponsor: Carol Davila University of Medicine and Pharmacy Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at babies born to mothers with intrahepatic cholestasis of pregnancy (ICP), a liver condition that causes itching and high bile acid levels. Researchers want to see if these bile acids can lead to breathing problems in newborns. They will compare 120 babies—some exposed to ICP and some not—to find out. The goal is to better understand and potentially prevent lung issues in these infants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

1 hour to 28 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

adult acute respiratory distress syndrome intrahepatic cholestasis intrahepatic cholestasis of pregnancy newborn respiratory distress syndrome Respiratory Distress Syndrome, Newborn

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intrahepatic cholestasis of pregnancy Respiratory distress syndrome, newborn

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

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

    Bucharest, Bucharest, 060251, Romania

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Other studies related to the condition(s) this trial covers.