Status:
TERMINATED
Type of Material in Repair of Congenital Diaphragmatic Hernia
Lead Sponsor:
Children's Mercy Hospital Kansas City
Conditions:
Congenital Diaphragmatic Hernia
Eligibility:
All Genders
Up to 2 years
Phase:
PHASE3
Brief Summary
The objective of this study is to evaluate the use of 2 different types of biosynthetic material for the repair of congenital diaphragmatic hernia. The research question is: what is the best material ...
Detailed Description
At birth, the estimated gestational age and birth weight will be recorded, as well as the presence and type of other congenital anomalies. Prior to operation, the length of time from birth to repair ...
Eligibility Criteria
Inclusion
- Infants admitted to the neonatal intensive care unit with a diagnosis of congenital diaphragmatic hernia as proven by chest x-ray showing enteric contents in the thoracic cavity will be considered. Those who have birth weight equal to or over 2.2 kilograms and who are at or beyond 34 weeks gestation at the time of birth who survive until an operation can be performed will be considered. At operation, the patients with posterolateral diaphragmatic defects (Bockdalek Hernia) large enough to require placement of a patch to recreate the diaphragm will be included in the study.
Exclusion
- Children diagnosed outside of the neonatal period will not be considered. Patients with the less common anteromedial or substernal defect (Morgagni Hernia) will not be included in the study as their physiology and rate of recurrence are incomparable to common posterolateral, Bockdalek Hernia.
- Those patients under 2.2 kilograms and less than 34 weeks gestation have poor lung maturity to compound their inherent difficulty with pulmonary parenchymal hypoplasia and pulmonary vasculature hypertension making their chances of survival extremely low. Further compounding their dismal circumstance, they are not candidates for salvage extracorporeal membrane oxygenation (ECMO). Therefore, they will not be candidates for the study.
- The rare case requiring repair of the hernia while on ECMO support will not be included due to the fact that this population has a very poor survival secondary to irreversible pulmonary hypertension. Further, the operation is performed while the patient is anticoagulated with heparin which is fraught with operative and post-operative bleeding.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
August 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00257946
Start Date
December 1 2005
End Date
August 1 2007
Last Update
December 15 2011
Active Locations (1)
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1
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108