Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Phase 3

• Conditions: Gastroschisis
• Interventions: Procedure: AMNIOECHANGE

• Registration Number: NCT00127946
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2005-08
• Study First Submitted: 2005-08-08
• Study First Submitted QC: 2005-08-08
• Study First Posted: 2005-08-09
• Study Start: 2005-11
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-09
• Primary Completion: 2012-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• Seen before 30 GA weeks
• Normal karyotype
• Single pregnancy
• Isolated gastroschisis
• No associated disease (maternal)
• Accept randomization and understand the study

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Exclusion Criteria

• Maternal diabetes
• Maternal infection with HIV, hepatitis
• Preexistent oligohydramnios before inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMNIOECHANGE	AMNIOECHANGE	The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.
placebo	AMNIOECHANGE	This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.

Primary Outcome Measures

Name	Time	Method
Duration of ventilation in the ICU and the duration of parenteral nutrition	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

Secondary Outcome Measures

Name	Time	Method
Evaluation of the contribution of iterative AMNIOECHANGE	7 days, 45 days, 12 months and 18 months	* Obstetric complications: chorioamnionitis, preterm labor, premature rupture of membranes,; * Aspect périviscérite, age out of intensive care and the initialization of enteral nutrition, infection; * Evaluation of complications of surgery, duration of hospitalization.; * And to determine prenatal prognostic factors: 1. Ultrasound 2. Biological and postnatal: Histology

Trial Locations

Locations (1)

Robert Debre hospital, AP-HP; 🇫🇷 Paris, France