Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | In the first 24 hours, at 48-72 hours and at 7 days of life |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | First 7 days of life |
| NICU admission |
Not provided
ICP-EXPOSED GROUP
Inclusion Criteria:
Exclusion Criteria:
UNEXPOSED GROUP
Inclusion Criteria:
Exclusion Criteria:
- ursodeoxycholic acid, independent of dosage or initiation of treatment (suspected hepatic disease/elevated transaminases)
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Hospital of Obstetrics and Gynecology "Prof. Dr. Panait Sârbu" | Bucharest | Bucharest | 060251 | Romania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41704598 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C535932 | Intrahepatic Cholestasis of Pregnancy |
| D012127 | Respiratory Distress Syndrome, Newborn |
| D002780 | Cholestasis, Intrahepatic |
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Serum extracted after centrifugation, frozen at minus 50 degrees Celsius
| 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 |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |