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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2005

Last Updated Date

August 8, 2011

Start Date ^ICMJE

November 2005

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00127946 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Official Title ^ICMJE

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 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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroschisis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

140

Estimated Completion Date

April 2012

Estimated Primary Completion Date

April 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00127946

Other Study ID Numbers ^ICMJE

P040416

Has Data Monitoring Committee

Responsible Party

Saliha DJANE, Department Clinical Research of Developpement

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Dominique Luton, MD, PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

August 2005

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

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