Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
试验速览
- 阶段
- 3 期
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Duration of ventilation in the ICU and the duration of parenteral nutrition
研究概览
简要总结
Hypothesis: Gastroschisis is a localised disruption of the abdominal layer. It occurs early in gestation, and the bowel is therefore bathing in the amniotic fluid and can be constricted at the level of the abdominal hole. The bowel is therefore submitted to different injuries partly attributable to the contact with amniotic fluid contaminated by digestive compounds and inducing an inflammatory reaction. Experimental studies on animal models and preliminary data in humans indicate that changing regularly the amniotic fluid (i.e. AMNIOECHANGE) would improve the outcome of theses fetuses and then neonates.
详细描述
Primary Objective: To compare prospectively the effect of AMNIOECHANGE against classical care on the delay of full enteral feeding in gastroschisis affected foetuses
Study:
- Multicenter, Randomized.
- Inclusion at 20 GA (gestational age) weeks.
- AMNIOECHANGE every 2 weeks from 30 GA weeks
Subject: 140 inclusion during 3 years
Analysis: Triangular Sequential Evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Seen before 30 GA weeks
- •Normal karyotype
- •Single pregnancy
- •Isolated gastroschisis
- •No associated disease (maternal)
- •Accept randomization and understand the study
排除标准
- •Maternal diabetes
- •Maternal infection with HIV, hepatitis
- •Preexistent oligohydramnios before inclusion
研究组 & 干预措施
AMNIOECHANGE
The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.
干预措施: AMNIOECHANGE (Procedure)
placebo
This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.
干预措施: AMNIOECHANGE (Procedure)
结局指标
主要结局
Duration of ventilation in the ICU and the duration of parenteral nutrition
时间窗: 7 days and 45 days after the birth of the child
The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition
次要结局
- Evaluation of the contribution of iterative AMNIOECHANGE(7 days, 45 days, 12 months and 18 months)