Fetal Surgery for Moderate Left Sided Congenital Diaphragmatic Hernia.

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.

Conditions

• Congenital Diaphragmatic Hernia
• Fetal Surgery
• Pulmonary Hypoplasia

Interventions

PROCEDURE

Fetoscopic Endoluminal Tracheal Occlusion

prenatal balloon placement at 30-31+6 weeks and removal at 34-34+6 wks

Sponsors & Collaborators

• King's College Hospital NHS Trust (UK)

  collaborator UNKNOWN

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hopital Antoine Beclere

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  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

• Baylor College of Medicine

  collaborator OTHER

• The University of Texas Health Science Center, Houston

  collaborator OTHER

• Medical University of Warsaw

  collaborator OTHER

• University Hospital, Gasthuisberg

  lead OTHER

Principal Investigators

• Jan A Deprest, MD PhD · Universitaire Ziekenhuizen KU Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-08-31

Primary Completion

2020-03-31

Completion

2020-03-31

Countries

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

Study Locations