Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diaphragmatic Hernia

Keywords

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Congenital diaphragmatic hernia tracheal occlusion fetus fetal surgery fetoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Fetoscopic tracheal balloon occlusion

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pregnant women from European countries carrying fetuses with congenital right or left diaphragmatic hernias
* Normal karyotype, no further severe anomalies on prenatal ultrasound study
* Fetal liver herniation into the chest, Lung-to-head ratio of ≥0,40 ≤0,84 between 30+0 - 33+5 weeks+days of gestation

Exclusion Criteria

* Any maternal disease or condition that would result in an increased risk to her personal health from the experimental procedure
* Abnormal fetal karyotype
* Further severe fetal anomalies on prenatal ultrasound

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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German Center for Fetal Surgery & Minimally-Invasive Therapy

Principal Investigators

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Thomas Kohl, MD

Role: PRINCIPAL_INVESTIGATOR

German Center for Fetal Surgery & Minimally-Invasive Therapy, University of Bonn, Germany

Thomas Schaible, MD

Role: PRINCIPAL_INVESTIGATOR

Neonatal Intensive Care Unit (ECMO center), University of Mannheim, Germany

Locations

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German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn

Bonn, , Germany

Site Status

Neonatal Intensive Care Unit (ECMO center), University of Mannheim

Mannheim, , Germany

Site Status

Countries

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Germany

References

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Kohl T, Gembruch U, Filsinger B, Hering R, Bruhn J, Tchatcheva K, Aryee S, Franz A, Heep A, Muller A, Bartmann P, Loff S, Hosie S, Neff W, Schaible T; German Center for Fetal Surgery Diaphragmatic Hernia Task Group. Encouraging early clinical experience with deliberately delayed temporary fetoscopic tracheal occlusion for the prenatal treatment of life-threatening right and left congenital diaphragmatic hernias. Fetal Diagn Ther. 2006;21(3):314-8. doi: 10.1159/000091363.

Reference Type BACKGROUND

PMID: 16601345 (View on PubMed)

Other Identifiers

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093/06

Identifier Type: -

Identifier Source: secondary_id

DH-EUROTRIAL I - 093/06