NCT01240057

Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia

Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragma Hernia and Severe Pulmonary Hypoplasia.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University Hospital, Gasthuisberg · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This trial investigates whether prenatal intervention improves survival rate of fetuses with isolated congenital diaphragmatic hernia and severe pulmonary hypoplasia, as compared to expectant management during pregnancy, both followed by standardized postnatal care.

Conditions

• Congenital Diseases
• Diaphragmatic Hernia
• Pulmonary Hypoplasia

Interventions

Type	Name	Description
PROCEDURE	fetal endoluminal tracheal occlusion	percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
OTHER	watchful waiting during pregnancy	pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening

Timeline

• Start date: 2011-11-01
• Primary completion: 2020-03-01
• Completion: 2020-12-01
• First posted: 2010-11-15
• Last updated: 2021-05-04

Locations

12 sites across 11 countries: United States, Australia, Belgium, Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom