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| Sponsors and Collaborators: |
University of California, San Francisco Children's Hospital Los Angeles Children's Memorial Hospital |
|---|---|
| Information provided by: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT00133679 |
Purpose
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 pulmonary vascular resistance following treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Hernia, Diaphragmatic Hypertension, Pulmonary Hypoplasia, Pulmonary |
Drug: sildenafil Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Chronic Sildenafil for Severe Diaphragmatic Hernia |
| Estimated Enrollment: | 32 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Sildenafil x 45 days
|
Drug: sildenafil
Sildenafil 0.5 mg/kg every 6 hours orally x 45 d
|
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2: Placebo Comparator
Placebo x 45 d
|
Drug: Placebo
Placebo suspension (equal volume to experimental drug) x 45 days
|
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 survivors. This proposal is a randomized, blinded, placebo-controlled study designed to evaluate the efficacy and potential mechanisms of activity of sildenafil, a phosphodiesterase-5 inhibitor, for treatment of severe CDH. Infants who meet criteria at ≥10d of age predicting a poor outcome [death or chronic lung disease (CLD) severe enough to require hospital discharge on supplemental oxygen (O2)] will be eligible for the study. Infants whose parents consent for the study will undergo an initial cardiac catheterization to assess the degree of pulmonary hypertension and the pulmonary vascular resistance. They will then begin either sildenafil or placebo therapy for a 45d course. A final cardiac catheterization will be performed after the experimental drug course is completed. The pulmonary vascular resistance and pulmonary arterial pressure during hyperoxic conditions will be compared between the sildenafil and placebo groups. Infants from either group who have severely elevated pulmonary arterial pressure or pulmonary vascular resistance at the final cardiac catheterization (despite supplemental O2) will be started on sildenafil, which will continue after hospital discharge.
Eligibility| Ages Eligible for Study: | up to 42 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Receiving assisted ventilation and
Exclusion Criteria:
Sildenafil contraindicated (until condition resolves):
Contacts and Locations| Contact: Roberta L Keller, MD | 415-514-3192 | kellerr@peds.ucsf.edu |
| Contact: Samuel Hawgood, MBBS | 415-476-9181 | hawgoods@peds.ucsf.edu |
| United States, California | |
| Children's Hospital of Los Angeles | Not yet recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Istvan Seri, MD 323-669-5932 iseri@chla.usc.edu | |
| Contact: Phillipe Friedlich, MD 323-669-5932 pfriedlich@chla.usc.edu | |
| Principal Investigator: Phillipe Friedlich, MD | |
| Sub-Investigator: Istvan Seri, MD | |
| University of California San Francisco Children's Hospital | Recruiting |
| San Francisco, California, United States, 94143 | |
| Contact: Roberta L Keller, MD 415-514-3192 kellerr@peds.ucsf.edu | |
| Contact: Samuel Hawgood, MD 415-476-9181 hawgoods@peds.ucsf.edu | |
| Principal Investigator: Roberta L Keller, MD | |
| Sub-Investigator: Samuel Hawgood, MBBS | |
| Sub-Investigator: Jeffrey R Fineman, MD | |
| Sub-Investigator: Phillip Moore, MD | |
| Sub-Investigator: Theresa A Tacy, MD | |
| United States, Illinois | |
| Children's Memorial Hospital | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| Contact: Nicolas Porta, MD n-porta@northwestern.edu | |
| Contact: Karin Hamann, RN (773) 975-8776 KHamann@childrensmemorial.org | |
| Principal Investigator: Nicolas Porta, MD | |
| Principal Investigator: | Roberta L Keller, MD | University of California, San Francisco |
More Information
| Responsible Party: | University of California San Francisco ( Roberta L. Keller, MD ) |
| Study ID Numbers: | K23HL79922-01 |
| Study First Received: | August 22, 2005 |
| Last Updated: | March 16, 2009 |
| ClinicalTrials.gov Identifier: | NCT00133679 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Chronic lung disease Nitric oxide cyclic guanosine monophosphate phosphodiesterase inhibitor |
|
Pathological Conditions, Anatomical Vasodilator Agents Vascular Diseases Sildenafil Cardiovascular Agents Nitric Oxide Phosphodiesterase Inhibitors |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases Hernia Hernia, Diaphragmatic Hypertension |
|
Pathological Conditions, Anatomical Vasodilator Agents Molecular Mechanisms of Pharmacological Action Vascular Diseases Sildenafil Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Phosphodiesterase Inhibitors |
Respiratory Tract Diseases Hypertension, Pulmonary Therapeutic Uses Hernia Lung Diseases Hernia, Diaphragmatic Cardiovascular Diseases Hypertension |
