Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia
NCT01240057 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 93
Last updated 2021-05-04
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
- 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
Sponsors & Collaborators
-
King's College Hospital NHS Trust (UK)
collaborator UNKNOWN -
Hospital Clinic of Barcelona
collaborator OTHER -
Hopital Antoine Beclere
collaborator OTHER -
University Hospital, Bonn
collaborator OTHER -
Mater Mothers' Hospital
collaborator OTHER -
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
collaborator OTHER -
Ospedale Pediatrico Bambino Gesù, Rome (IT)
collaborator UNKNOWN -
Mount Sinai Hospital, Canada
collaborator OTHER -
National Center for Child Health and Development, Tokyo (JP)
collaborator UNKNOWN -
The University of Texas Health Science Center, Houston
collaborator OTHER -
Medical University of Warsaw
collaborator OTHER -
University Hospital, Gasthuisberg
lead OTHER
Principal Investigators
-
Jan Deprest, MD · Universitaire Ziekenhuizen KU Leuven
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-11-30
- Primary Completion
- 2020-03-31
- Completion
- 2020-12-31
Countries
- United States
- Australia
- Belgium
- Canada
- France
- Germany
- Italy
- Japan
- Poland
- Spain
- United Kingdom
Study Locations
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