Intrahepatic Cholestasis of Pregnancy and the Respiratory Challenges of Bile Acids Pneumonia in Neonates (The CHOLE-RESP Trial)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of respiratory distress syndrome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Hour 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
结局指标
主要结局
Incidence of respiratory distress syndrome
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Neonatal mortality(From day 1 of life until 28 days of life)
- Respiratory morbidity(First 7 days of life)
- NICU admission(First 48-72 hours of life)
- Length of hospitalization(From day 1 of life until discharge)
研究者
Niculae Lucia-Elena
Doctoral Student, Medical Resident Neonatologist
Carol Davila University of Medicine and Pharmacy