Chronic Sildenafil for Severe Diaphragmatic Hernia

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Hernia, Diaphragmatic, Hypertension, Pulmonary, Hypoplasia, Pulmonary

In brief

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.

Key facts

Study ID

NCT00133679

Run by

University of California, San Francisco

People needed

9

Starts

2006-02-01

Expected to finish

2013-10-01

Last updated by the study team

2021-01-13

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• University of California San Francisco Children's Hospital — San Francisco, California, United States
• Children's Memorial Hospital — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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