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Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

NCT00373763 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2008-08-25

No results posted yet for this study

Summary

Diaphragmatic hernia detected in fetal life carries a high risk for postnatal demise due to lung underdevelopment. Clinical experience from prospective controlled non-randomized case series with fetoscopic tracheal balloon occlusion has seen improved survival rates in contrast to untreated controls. Therefore, the purpose of this randomized clinical trial is to provide further evidence about the efficacy and safety of the prenatal interventional approach. Primary outcome measure is postnatal survival to discharge from hospital treatment.

Conditions

  • Diaphragmatic Hernia

Interventions

PROCEDURE

Fetoscopic tracheal balloon occlusion

Sponsors & Collaborators

  • Universitätsmedizin Mannheim

    collaborator OTHER

  • University Hospital, Bonn

    lead OTHER

Principal Investigators

  • Thomas Kohl, MD · German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany

  • Thomas Schaible, MD · Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2008-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00373763 on ClinicalTrials.gov