Chronic Sildenafil for Severe Diaphragmatic Hernia

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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 or prolonged oxygen supplementation on mechanical ventilation), as measured by the estimated pulmonary artery systolic pressure following treatment.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Ann & Robert H Lurie Children's Hospital of Chicago; Children's Hospital Los Angeles
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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