Clinical Trials Logo

Clinical Trial Summary

The purpose of this phase 2 limited study is to examine whether prenatal intervention correct the lung underdevelopment associated with severe diaphragmatic hernia.


Clinical Trial Description

Congenital diaphragmatic hernia (CDH) has traditionally been associated with very high mortality rates. Most infants died of pulmonary hypoplasia and severe pulmonary hypertension. This led to correction of CDH and pulmonary hypoplasia before birth. Unfortunately, maternal morbidity of open fetal surgery was significant and fetal mortality was very high (>60%). Moreover, the results of postnatal therapy for CDH improved dramatically, from less than 20% survival several decades ago to more than 70% today.

Fetal intervention has evolved as well, to a minimally invasive approach that involves a single endoscopic port and occlusion of the fetal trachea. While this has considerably decreased the morbidity and fetal mortality of the in utero procedure, its results do not exceed the overall (i.e., non-stratified) results of contemporary postnatal treatment. Most recently, a multicentric cooperative study under (Eurofoetus) has conducted a clinical trial comparing postnatal treatment with endoscopic fetal tracheal occlusion for the most severe forms of CDH. Results of the Eurofoetus trial and of a recent retrospective review involving European and North-American centers have shown the following: 1) It is possible to identify a specific subgroup of fetuses with CDH in whom survival can be predicted to be less than 10%, despite all current methods of postnatal treatment, 2) Survival of fetuses with predicted postnatal survival of 8% was >50% following endoscopic fetal tracheal occlusion, and 3) Fetal tracheal occlusion in that group resulted in an increase in lung size (LHR), from an average of 0.7 pre-intervention, to 1.7 post-intervention.

Based on the available research literature, the results of the Eurofoetus trial, and this institution's experience with endoscopic fetal surgery, we hypothesize that in the highest risk group of fetuses with congenital diaphragmatic hernia, where chances of survival is estimated at less than 10%, endoscopic fetal tracheal occlusion in late second trimester, with reversal of occlusion in mid-third trimester, allows catch-up lung growth and maturation and converts the condition into one with intermediate to good prognosis (predicted survival 50-60%). We propose to offer this form of treatment, under an FDA-approved Investigational Device Exemption (G080077), to eligible patients, on a case-by-case basis, after discussion before a multidisciplinary board. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00966823
Study type Interventional
Source Rhode Island Hospital
Contact
Status Terminated
Phase Phase 2
Start date September 2008
Completion date January 2015

See also
  Status Clinical Trial Phase
Completed NCT02217423 - Abdominal Circumference and Cardiorespiratory Repercussions in Patients Submitted to Physical Therapy N/A
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02345135 - Susceptibility to Infections in Ataxia Telangiectasia N/A
Completed NCT01679301 - Evaluation of Sleep Mode Within the Respironics SimplyGo Portable Oxygen Concentrator N/A
Completed NCT00139152 - Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair Phase 4
Completed NCT00052052 - An Open-Label Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b (IFN-Gamma 1b) in Patients With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Completed NCT00013949 - Cardiovascular Vulnerability to Particulate Exposure N/A
Recruiting NCT02963467 - Effect of Smoking on Ventilation-Perfusion Ratio N/A
Recruiting NCT02965300 - The Value of VOCs Analysis in Exhaled Breath for Pulmonary Benign and Malignant Lesion Diagnosis N/A
Enrolling by invitation NCT02946658 - Use of Autologous, Adult Adipose-Derived Stem/Stromal Cells In Chronic Lung Disorders Phase 1/Phase 2
Recruiting NCT02913365 - Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis N/A
Completed NCT01735526 - Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide After Hematopoietic Stem-cell Transplantation N/A
Completed NCT01952002 - Clinical Safety for the Inspiratory Muscle Training N/A
Recruiting NCT01450644 - Evaluation of the Hospital2Home Palliative Care Service for Patients With Advanced Progressive Lung Disease Phase 2
Completed NCT01153321 - Investigation of the Effect of Oral Treatment With 100 mg AZD2423 in Subjects With Mild Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Completed NCT01215279 - AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD) Phase 2
Completed NCT00837681 - Pulmonary Complications of Hematopoietic Stem Cell Transplantation N/A
Completed NCT02055222 - Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
Completed NCT01222442 - To Evaluate the Effect of AZD3199 on the Electrical Activity in the Heart Phase 1
Recruiting NCT02723474 - A Single-Centre Pilot Study Exploring the Utility of Magnetic Resonance Imaging in Patients With Chronic Lung Disease N/A