Fetoscopic Tracheal Balloon Occlusion in Left Diaphragmatic Hernia

Diaphragmatic Hernia Clinical Trial

Official title:
Randomized Clinical Trial in Order to Assess the Effect of Fetoscopic Tracheal Balloon Occlusion on the Postnatal Disease Course in Neonates With Left Congenital Diaphragmatic Hernia - FDH-ECMO/BALLOON-TRIAL

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00373438
Study type	Interventional
Source	University Hospital, Bonn
Contact	Thomas Kohl, MD
Phone	-49-228-2871-5942
Email	thomas.kohl@ukb.uni-bonn.de
Status	Recruiting
Phase	Phase 2
Start date	January 2009
Completion date	July 2014

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See also
Status	Clinical Trial	Phase
Terminated	`NCT00966823` - Fetal Tracheal Balloon Study in Diaphragmatic Hernia	Phase 2
Completed	`NCT00371241` - Antibody Secreting Cell and Cyotokine Profiles in Neonates on ECMO
Completed	`NCT04716166` - Incentive Spirometry and Upper Abdominal Laparoscopic Surgery	N/A
Not yet recruiting	`NCT05354505` - Fetal Endoscopic Tracheal Occlusion (FETO) Trial for Congenital Diaphragmatic Hernia (CDH)	N/A
Completed	`NCT01240057` - Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia	Phase 2/Phase 3
Completed	`NCT02466451` - Study in Children With the Diagnosis of Congenital Diaphragmatic Hernia (CDH) and Oesophageal Atresia (EA)	N/A
Withdrawn	`NCT00373763` - Fetoscopic Tracheal Balloon Occlusion in Unborns With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I	N/A
Terminated	`NCT02364843` - A Physiological Study to Determine the Enteral Threonine Requirements in Infants Aged 1 to 6 Months	N/A