Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Number of neonates with hyaline membrane disease
研究概览
简要总结
Primary purpose: to study the relationship between betamethasone placental transfer and the occurrence and severity of the Hyaline Membrane Disease.
详细描述
β-Mhyalines is a prospective multicentric non interventional study. One hundred fifty pregnant women at risk of premature delivery, in the framework of Hyaline Membrane Disease of the neonate, will receive 2 intramuscular injections of Celesten (betamethasone) at 24 hours interval. Plasma samples will be collected: 2 in the mother before delivery, one maternal and one cord samples at delivery. Concentrations will be measured and analyzed using a population approach. A ratio between neonatal and maternal exposure will be calculated to represent placental transfer. The effect of covariates (genetic polymorphism for CYP3A4, CYP3A5, P-glycoprotein…, and others variables as gestational age, bodyweight at birth, apgar score, co-medication, maternal disease) will be tested to explain the variability of placental transfer. The relationship between placental transfer and the occurrence and severity of the Hyaline Membrane Disease will then be study, in order to target betamethasone maternal concentration and thus to optimize the antenatal dose to administer to the mother in the framework of Hyaline Membrane Disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women who received at least a first injection of Celesten in the prevention of MMH.
- •A one-term> 27 SA,
- •Major Patients > or = 18 years old
- •Informed Consent Form signed
排除标准
- •Patients undergoing treatment with corticosteroids in the long term
研究组 & 干预措施
Celesten in prevention of hyaline membrane disease.
Pregnant women that received at least a first injection of Celesten in the prevention of hyaline membrane disease.
结局指标
主要结局
Number of neonates with hyaline membrane disease
时间窗: 3 days
respiratory symptoms (respiratory rhythm disorders, signs of retraction, cyanosis, oxgen dependance \>30 %). Confirmation by radiology
次要结局
- Apgar score(Day 7)
- mode of delivery(Day 7)
- Genetic polymorphisms(Day 1)
- blood sample of betamethasone(Day 1 and day 2)
- gestational age(Day 7)
- birth weight(Day 7)
- Optimal dose of betamethasone(Day 28)
- time between birth and the last dose(Day 7)
- ethnicity(Day 7)
- sex(Day 7)
- twinning(Day 7)
- maternal disease and treatment(Day 7)
