CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 93 enrolled
Drug / intervention
fetal endoluminal tracheal occlusion +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01240057
NCT01240057Phase 3Completed
CompareCT.gov

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.

University Hospital, Gasthuisberg·interventional·Posted Nov 15, 2010·Updated May 4, 2021

In Brief

A Phase 3 clinical trial evaluating fetal endoluminal tracheal occlusion and watchful waiting during pregnancy for Congenital Diseases and 2 related conditions. Completed, enrolled 93 participants across 12 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Diseases, Diaphragmatic Hernia, Pulmonary Hypoplasia
CountriesAustralia, Belgium, Canada, France, Germany, Italy, Japan, Poland, Spain, United Kingdom, United States
CollaboratorsKing's College Hospital NHS Trust, Hospital Clinic of Barcelona, Hopital Antoine Beclere, University Hospital, Bonn, Mater Mothers' Hospital, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Ospedale Pediatrico Bambino Gesù, Rome (IT), Mount Sinai Hospital, Canada, National Center for Child Health and Development, Japan, The University of Texas Health Science Center, Houston, Medical University of Warsaw

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 15, 2010
Enrollment StartNov 1, 2011
Primary CompletionMar 1, 2020
Study CompletionDec 1, 2020
TodayJul 2, 2026
Enrollment to primary: 8.3 yearsPosted 15.6 years ago

Interventions

fetal endoluminal tracheal occlusionprocedure

percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks

watchful waiting during pregnancyother

pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening