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
  Purpose

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.


Condition Intervention Phase
Gastroschisis
Procedure: AMNIOECHANGE
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Trial of AMNIOECHANGE in Gastroschisis Affected Foetuses

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 140
Study Start Date: November 2005
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMNIOECHANGE
The AMNIOECHANGE consists of a transabdominal infusion of saline.They will be repeated every 15 days from 30 week of amenorrhea.
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
No Intervention: placebo
This will be done at the same place and under the same aseptic conditions a AMNIOECHANGE true.
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00127946

Locations
France
Robert Debre hospital, AP-HP
Paris, France, 75019
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Dominique Luton, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Saliha DJANE, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier: NCT00127946     History of Changes
Other Study ID Numbers: P040416
Study First Received: August 8, 2005
Last Updated: August 8, 2011
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 16, 2014