Status:
TERMINATED
Chronic Sildenafil for Severe Diaphragmatic Hernia
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Children's Hospital Los Angeles
Ann & Robert H Lurie Children's Hospital of Chicago
Conditions:
Hernia, Diaphragmatic
Hypertension, Pulmonary
Eligibility:
All Genders
10-42 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to test if sildenafil is effective in the treatment of infants with severe congenital diaphragmatic hernia (determined by the presence of prolonged pulmonary hypertension ...
Detailed Description
Congenital diaphragmatic hernia (CDH) is a condition characterized by pulmonary parenchymal and vascular hypoplasia. Severe CDH carries a high rate of mortality, and significant morbidity among surviv...
Eligibility Criteria
Inclusion
- Congenital diaphragmatic hernia
- 10-42 days (d) of age
- Significant illness severity as demonstrated by:
- Receiving assisted ventilation and
- FiO2 \>= 0.40 at 10-14d of age, or
- FiO2 \>= 0.40 for \>=48hours at 15-27d of age, or
- FiO2 \>= 0.35 at 28-42d of age
- Or, need for extracorporeal support at \>=10d of age
- Or, estimated pulmonary arterial or right ventricular systolic pressure of \>= 2/3 systemic pressure at 14-42d of age
Exclusion
- Structural congenital heart disease (other than patent ductus arteriosus or patent foramen ovale/atrial septal defect \[ASD\] or non-hemodynamically significant ventricular septal defect \[VSD\])
- Sildenafil contraindicated (until condition resolves):
- Unable to absorb oral medication, or
- Unstable systemic blood pressure, or
- Receiving a drug that may interfere with sildenafil metabolism, or
- Renal insufficiency
- Hepatic insufficiency Previous use of sildenafil
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00133679
Start Date
February 1 2006
End Date
October 1 2013
Last Update
January 13 2021
Active Locations (3)
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1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California San Francisco Children's Hospital
San Francisco, California, United States, 94143
3
Children's Memorial Hospital
Chicago, Illinois, United States, 60614