Clinical Trials Logo
  1. Home
  2. Congenital Diaphragmatic Hernia
  3. NCT00763737
  4. Details
NCT00763737 Clinical Trial

Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.

Congenital Diaphragmatic Hernia Clinical Trial

— TOTAL moderate  

Official title:
Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00763737
Other study ID # B32220084540
Secondary ID 2008-4634ML4999-
Status Completed
Phase N/A
First received
Last updated
Start date August 2010
Est. completion date March 2020

Study information
Verified date November 2020
Source University Hospital, Gasthuisberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and remains associated with a 30 % chance of perinatal death and morbidity mainly because of pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases. The risk for these can be predicted prenatally by the ultrasonographic measurement of the observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of pulmonary hypoplasia. Also position of the liver is predictive of outcome. The proposing consortium has developed a prenatal therapeutic approach, which consists of percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the balloon. Both procedures are performed percutaneously, there is now experience with more than 150 cases and it has been shown to be safe for the mother. We have witnessed an improvement of survival in fetuses with a predicted chance of survival of less than 30% (referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation) to 55% on average. Also there is an apparent reduction in morbidity with the rate of bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than 40% in the same severity group. Further we have shown that results of FETO are predicted by LHR measurement prior to the procedure, so that better results can be expected in fetuses with larger lung size. Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%, irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation of the liver). When managed expectantly the estimated rate of postnatal survival is 55%. This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant management during pregnancy, both followed by standardized postnatal management increases survival or decrease oxygen dependency at 6 months of age. The balloon will be placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.

Read more »

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Fetoscopic Endoluminal Tracheal Occlusion
prenatal balloon placement at 30-31+6 weeks and removal at 34-34+6 wks
See more »

Sponsors (13)
Lead Sponsor Collaborator
University Hospital, Gasthuisberg 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Warsaw (PL), Baylor College of Medicine, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Hopital Antoine Beclere, Hôpital Necker-Enfants Malades, Hospital Clinic of Barcelona, King's College Hospital NHS Trust (UK), Mater Mothers' Hospital, Mount Sinai Hospital, Canada, Ospedale Pediatrico Bambino Gesù, Rome (IT), The University of Texas Health Science Center, Houston, University Hospital, Bonn

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  France,  Germany,  Italy,  Poland,  Spain,  United Kingdom, 

References & Publications (16)

See more »

Outcome
Type Measure Description Time frame Safety issue
Primary Survival at discharge at the time of discharge from NICU, approximately 2 months
Primary Supplemental oxygen at 6 months of age at 6 months of age
Secondary Grading of oxygen dependency between 28 and 56 days of life if born >32 weeks; at 36 weeks postmenstrual age if born <32 weeks
Secondary Pulmonary hypertension during NICU admission
Secondary Use of extracorporeal membrane oxygenation during NICU admission
Secondary Change in O/E LHR after FETO prior to unplug
Secondary NICU days during NICU admission
Secondary days of ventilatory support during NICU admission
Secondary Periventricular leucomalacia during NICU admission
Secondary Neonatal sepsis during NICU admission
Secondary Intraventricular hemorrhage during NICU admission
Secondary Retinopathy of prematurity during NICU admission
Secondary Days until full enteral feeding during NICU admission
Secondary Gastroesophageal reflux during NICU admission
Secondary Day of postnatal surgery during NICU admission
Secondary Use of patch at the time of postnatal surgery
Secondary Defect size at the time of postnatal surgery
Secondary Number of days alive in case of postnatal death during NICU admission
See also
  Status Clinical Trial Phase
Recruiting NCT05100693 - Smart Removal for Congenital Diaphragmatic Hernia N/A
Recruiting NCT05450653 - Trial of FETO for Severe Congenital Diaphragmatic Hernia N/A
Terminated NCT04140669 - Automated Myocardial Performance Index Using Samsung HERA W10
Recruiting NCT05201144 - A Trial of Phosphodiesterase-5 Inhibitor in Neonatal Congenital Diaphragmatic Hernia (TOP-CDH) Phase 2
Not yet recruiting NCT06281717 - Fetal Endotracheal Occlusion (FETO) in Fetuses With Severe Congenital Diaphragmatic Hernia N/A
Recruiting NCT04429750 - Intact Cord Resuscitation in CDH N/A
Recruiting NCT03750266 - 3D Animation and Models to Aid Management of Fetal CDH
Not yet recruiting NCT05421676 - Fetal Endoscopic Tracheal Occlusion for CDH (CDH) N/A
Completed NCT01243229 - Genetic Analysis of Congenital Diaphragmatic Disorders
Recruiting NCT04583644 - Pilot Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) in Severe Left Congenital Diaphragmatic Hernia (CDH) N/A
Completed NCT03314233 - Delayed Cord Clamping for Congenital Diaphragmatic Hernia N/A
Recruiting NCT04114578 - Exploratory Observational Prospective Study in Neonatal and Pediatric Congenital Diaphragmatic Hernia
Completed NCT03666767 - Management and Outcomes of Congenital Anomalies in Low-, Middle- and High-Income Countries
Recruiting NCT02986087 - Feto-Endoscopic Tracheal Occlusion (FETO) for Left Congenital Diaphragmatic Hernia N/A
Recruiting NCT03674372 - Fetoscopic Endoluminal Tracheal Occlusion N/A
Active, not recruiting NCT05839340 - Neurally Adjusted Ventilatory Assist for Neonates With Congenital Diaphragmatic Hernias N/A
Enrolling by invitation NCT05962346 - Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia N/A
Withdrawn NCT04186039 - Functional Evaluation of the Fetal Lung by Functional Magnetic Resonance Imaging - Blood Oxygenation Level Dependent (MRI-BOLD), in Congenital Diaphragmatic and Parietal Malformations N/A
Unknown status NCT01302977 - Fetal Tracheal Occlusion in Severe Diaphragmatic Hernia: a Randomized Trial Phase 2
Recruiting NCT03179371 - Proteomic Profiling for Congenital Diaphragmatic Hernia

External Links