Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
This trial is active, not recruiting.
|Sponsor||Assistance Publique - Hôpitaux de Paris|
|Start date||November 2005|
|End date||April 2012|
|Trial size||140 participants|
|Trial identifier||NCT00127946, P040416|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
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
Evaluation of the contribution of iterative AMNIOECHANGE
time frame: 7 days, 45 days, 12 months and 18 months
Female participants at least 18 years old.
Inclusion Criteria: - Seen before 30 GA weeks - Normal karyotype - Single pregnancy - Isolated gastroschisis - No associated disease (maternal) - Accept randomization and understand the study Exclusion Criteria: - Maternal diabetes - Maternal infection with HIV, hepatitis - Preexistent oligohydramnios before inclusion
|Official title||Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses|
|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|
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