Clinical Trial: Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

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 Summary:

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


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Duration of ventilation in the ICU and the duration of parenteral nutrition [ Time Frame: 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


Original Primary Outcome:

Current Secondary Outcome: Evaluation of the contribution of iterative AMNIOECHANGE [ Time Frame: 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


Original Secondary Outcome:

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 8, 2005
Date Started: November 2005
Date Completion: April 2012
Last Updated: August 8, 2011
Last Verified: August 2005