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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

November 30, 2011

Primary Completion Date

March 31, 2020

Study Completion Date

December 31, 2020

Conditions
Congenital DiseasesDiaphragmatic HerniaPulmonary 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

Trial Locations (12)

3000

University Hospitals Leuven, Leuven

4101

Mater Mother's Hospital, Brisbane

20122

Ospedale Maggiore Policlinico, Milan

53105

University Hospital of Bonn, Bonn

77030

University of Texas Health Science Center, Houston

92141

Hôpital Antoine Béclère, Clamart

M5G 1X5

Mount Sinai Hospital, Toronto

00123

Ospedale Pediatrico Bambino Gesù, Rome

157-8535

National Center for Child Health and Development, Tokyo

Unknown

1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Warsaw

08028

Hospital Clinic Barcelona, Barcelona

SE5 9RS

King's College Hospital, London

All Listed Sponsors
collaborator

King's College Hospital NHS Trust (UK)

UNKNOWN

collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

Hopital Antoine Beclere

OTHER

collaborator

University Hospital, Bonn

OTHER

collaborator

Mater Mothers' Hospital

OTHER

collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

collaborator

Ospedale Pediatrico Bambino Gesù, Rome (IT)

UNKNOWN

collaborator

Mount Sinai Hospital, Canada

OTHER

collaborator

National Center for Child Health and Development, Tokyo (JP)

UNKNOWN

collaborator

The University of Texas Health Science Center, Houston

OTHER

collaborator

Medical University of Warsaw

OTHER

lead

University Hospital, Gasthuisberg

OTHER

NCT01240057 - Tracheal Occlusion To Accelerate Lung Growth (TOTAL) Trial for Severe Pulmonary Hypoplasia | Biotech Hunter | Biotech Hunter