Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00127946
First received: August 8, 2005
Last updated: August 8, 2011
Last verified: August 2005

August 8, 2005
August 8, 2011
November 2005
April 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
The primary outcome was a composite endpoint based on the duration of ventilation in the ICU and the duration of parenteral nutrition
Not Provided
Complete list of historical versions of study NCT00127946 on ClinicalTrials.gov Archive Site
Evaluation of the contribution of iterative AMNIOECHANGE [ Time Frame: 7 days, 45 days, 12 months and 18 months ] [ Designated as safety issue: No ]
  • 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
Not Provided
Not Provided
Not Provided
 
Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses
Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

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:

  • 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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Gastroschisis
Procedure: AMNIOECHANGE
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.
Other Name: AMNIOECHANGE
  • Active Comparator: AMNIOECHANGE
    The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.
    Intervention: Procedure: AMNIOECHANGE
  • No Intervention: placebo
    This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.
    Intervention: Procedure: AMNIOECHANGE
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00127946
P040416
No
Saliha DJANE, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Dominique Luton, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP