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临床试验/NCT01854840
NCT01854840已完成不适用

Betamethasone and Severity of Hyaline Membrane Disease in the Newborn Premature

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2012年1月12日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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