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

Diaphragmatic Hernia Clinical Trial

Official title:

Randomized Clinical Trial for the Assessment of the Life-Saving Potential of Fetoscopic Tracheal Balloon Occlusion in Fetuses With Severe Congenital Diaphragmatic Hernia - EUROTRIAL I

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00373763
• Other study ID #: DH-EUROTRIAL I - 093/06
• Secondary ID: 093/06
• Status: Withdrawn
• Phase: N/A
• First received: September 6, 2006
• Last updated: August 22, 2008
• Start date: January 2007

Study information

• Verified date: August 2008
• Source: University Hospital, Bonn
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 98
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diaphragmatic Hernia
• Hernia
• Hernia, Diaphragmatic

Intervention

Procedure:
• Fetoscopic tracheal balloon occlusion

Locations

Country	Name	City	State
Germany	German Center for Fetal Surgery & Minimally-Invasive Therapy-University of Bonn	Bonn
Germany	Neonatal Intensive Care Unit (ECMO center), University of Mannheim	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bonn	Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to discharge from hospital
Secondary	Maternal morbidity
Secondary	Fetal morbidity
Secondary	Premature preterm rupture of membranes
Secondary	Unintended preterm delivery
Secondary	Conventional ventilation strategies possible
Secondary	ECMO required
Secondary	Days in intensive care
Secondary	Days in hospital
Secondary	Oxygen dependency on discharge