Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127946
Status:
UNKNOWN
Last Update Posted:
2011-08-09
First Post:
2005-08-08
Brief Title:
Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMNIOECHANGE
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 ie 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None