Intrahepatic Cholestasis of Pregnancy, Respiratory Distress Syndrome, Newborn
Conditions
Keywords
bile-acid pneumonia, cholestasis of pregnancy, intrahepatic cholestasis, RDS, respiratory distress syndrome
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.
Interventions
None listed
Sponsors
Carol Davila University of Medicine and Pharmacy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 28 Days
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respiratory distress syndrome | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Respiratory morbidity | 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. |
| 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 | — |
Countries
Romania
Outcome results
None listed