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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.
Primary Objective: To compare prospectively the effect of AMNIOECHANGE against classical care on the delay of full enteral feeding in gastroschisis affected foetuses
Study:
Subject: 140 inclusion during 3 years
Analysis: Triangular Sequential Evaluation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMNIOECHANGE | Active Comparator | The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea. |
|
| placebo | No Intervention | This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMNIOECHANGE | Procedure | The AMNIOECHANGE consists of a transabdominal infusion of saline (heated to 37 ° C) with a needle 18 or 20 gauge under ultrasound monitoring while avoiding the placenta. In the case of a normal amniotic fluid, it must be replaced volume per volume of saline (eg depending on the tank where the puncture is made, it can be 300 per 300 ml). The total amount of amniotic fluid exchange is 600-900 ml. In cases of oligohydramnios, the AMNIOECHANGE results in a normalized volume of amniotic fluid. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of ventilation in the ICU and the duration of parenteral nutrition | The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition | 7 days and 45 days after the birth of the child |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the contribution of iterative AMNIOECHANGE |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dominique Luton, MD, PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Debre hospital, AP-HP | Paris | Paris | 75019 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31033140 | Derived | Luton D, Mitanchez D, Winer N, Muller F, Gallot D, Perrotin F, Jouannic JM, Bretelle F, de Lagausie P, Ville Y, Guibourdenche J, Oury JF, Alberti C, Benachi A. A randomised controlled trial of amnioexchange for fetal gastroschisis. BJOG. 2019 Sep;126(10):1233-1241. doi: 10.1111/1471-0528.15804. Epub 2019 May 20. |
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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
| 7 days, 45 days, 12 months and 18 months |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |