Intrahepatic Cholestasis of PregnancyCHOLE-RESPNCT06679972
Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
An observational study of Intrahepatic Cholestasis of Pregnancy and Respiratory Distress Syndrome, Newborn, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 hour to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- 28 Oct 2024to 1 Mar 2028
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 28 days
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site
Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu"
Bucharest, Bucharest, 060251
About this study
Official title: Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)
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.
Read the detailed description
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.
- Keywords
- bile-acid pneumonia, cholestasis of pregnancy, intrahepatic cholestasis, RDS, respiratory distress syndrome
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn, Cholestasis, Intrahepatic, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: In the first 24 hours, at 48-72 hours and at 7 days of life
Secondary outcomes (4)
Respiratory morbidity
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.
Measured: First 7 days of life
NICU admission
Measured: First 48-72 hours of life
Length of hospitalization
Measured: From day 1 of life until discharge
Neonatal mortality
Measured: From day 1 of life until 28 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start28 Oct 2024
- Primary completion10 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Carol Davila University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Niculae Lucia-Elena, Carol Davila University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679972
- Sponsor's protocol ID
- 34/15.10.2024
- Acronym
- CHOLE-RESP
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41704598
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)
- ClinicalTrials.gov ID
- NCT06679972
- Acronym / sponsor ID
- CHOLE-RESP / 34/15.10.2024
- Keywords
- bile-acid pneumonia, cholestasis of pregnancy, intrahepatic cholestasis, RDS, respiratory distress syndrome
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Carol Davila University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (5 listed)
- 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
- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
4 secondary outcomes
Respiratory morbidity
Time frame: First 7 days of life
NICU admission
Time frame: First 48-72 hours of life
Length of hospitalization
Time frame: From day 1 of life until discharge
Neonatal mortality
Time frame: From day 1 of life until 28 days of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 41704598Niculae 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrahepatic Cholestasis of Pregnancy and Respiratory Distress Syndrome, Newborn, run by Carol Davila University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory distress syndrome (time frame: First 72 hours of life). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679972, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.