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Chronic Sildenafil for Severe Diaphragmatic Hernia

NCT00133679 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-01-13

Study results available
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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.

Conditions

  • Hernia, Diaphragmatic
  • Hypertension, Pulmonary
  • Hypoplasia, Pulmonary

Interventions

DRUG

sildenafil

Sildenafil 0.5 mg/kg every 6 hours orally x 45 d

DRUG

Placebo

Placebo suspension (equal volume to experimental drug) x 45 days

Sponsors & Collaborators

Principal Investigators

  • Roberta L Keller, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Days
Max Age
42 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Primary Completion
2013-07-31
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00133679 on ClinicalTrials.gov