Type of Material in Repair of Congenital Diaphragmatic Hernia

NCT00257946 | Terminated Phase 3

• 1 other identifier: 0510128
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 for repairing large congenital diaphragmatic hernias? The primary outcome variable is recurrence.

Conditions

Congenital Diaphragmatic Hernia

Keywords

Diaphragm; Hernia; Congenital

Outcome Measures

Primary Outcomes (1)

• Recurrence of Diaphragmatic Hernia

Secondary Outcomes (3)

• Bowel Obstruction

• Ventilatory days

• Ventilatory status at follow-up

Interventions

Repair of CDH w/SIS Gold PROCEDURE

Repair of CDH w/Alloderm PROCEDURE

Eligibility Criteria

• Age: Up to 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Hernias, Diaphragmatic, Congenital; Hernia

Condition Hierarchy (Ancestors)

Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Shawn D St. Peter, MD

  Children's Mercy Hospital Kansas City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 22, 2005
• First Posted: November 24, 2005
• Study Start: December 1, 2005
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 15, 2011

Record last verified: 2011-12

Locations

US (1)