Clinical trial NCT06679972: Impact of Intrahepatic Cholestasis of Pregnancy on Neonatal Respiratory Outcomes
Official title: Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Intrahepatic Cholestasis of Pregnancy
Respiratory Distress Syndrome, Newborn
Keywords: bile-acid pneumonia
cholestasis of pregnancy
intrahepatic cholestasis
RDS
respiratory distress syndrome
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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 cholestasis group, the study population is represented by neonates born to mothers with intrahepatic cholestasis diagnosed during pregnancy. The control group will include neonates of similar gestational age/weight/sex at birth born to mothers with no hepatic diseases.

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.

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.

Eligibility criteria: CASE

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"

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

CONTROL

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 cholestasis group

Exclusion Criteria:

* ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
* newborns transferred from other neonatal units, with different gestational age/weight/sex than cases

Primary outcomes:
measure: Biomarkers of epithelial injury
timeFrame: In the first 24 hours, at 2-3 days and at 7 days of life
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu"
Study officials:
References: