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Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

NCT00373438 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2009-01-06

No results posted yet for this study

Summary

Left diaphragmatic hernia detected during fetal life carries a high risk for postnatal lung failure due to lung underdevelopment and pulmonary hypertension. In severe cases, extracorporeal membrane oxygenation (ECMO) is used as a life-saving intensive care means to enable survival of severely affected infants.

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 in a less severely affected subgroup of patients is whether by fetoscopic tracheal occlusion, the intensity of postnatal intensive care therapy might be reduced. Primary outcome measure is the need for postnatal ECMO therapy.

Conditions

  • Diaphragmatic Hernia

Interventions

PROCEDURE

Fetoscopic tracheal balloon occlusion

Maternal local anesthesia, percutaneous ultrasound-guided fetal analgo-sedation and relaxation, percutaneous ultrasound-guided access into amniotic cavity with trocar, fetoscopic tracheal ballon occlusion, removal of fetoscope and trocar, maternal abdominal closure, skin-to-skin time 30 minutes

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
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2014-01-31
Completion
2014-07-31

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 NCT00373438 on ClinicalTrials.gov