Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133679
Status:
TERMINATED
Last Update Posted:
2021-01-13
First Post:
2005-08-22
Brief Title:
Chronic Sildenafil for Severe Diaphragmatic Hernia
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Chronic Sildenafil for Severe Diaphragmatic Hernia
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change in clinical practice allowing chronic therapy at 6 weeks of age incompatible with possibility of placebo beyond 6 weeks of age on study protocol
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 or prolonged oxygen supplementation on mechanical ventilation as measured by the estimated pulmonary artery systolic pressure following treatment
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 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 echocardiogram to assess the degree of pulmonary hypertension They will then begin either sildenafil or placebo therapy for a 45d course A final echocardiogram will be performed after the experimental drug course is completed The pulmonary arterial systolic pressure estimate during hyperoxic conditions will be compared between the sildenafil and placebo groups Infants from either group who have severely elevated pulmonary arterial pressure despite supplemental O2 will be considered for open-label sildenafil which will continue after hospital discharge depending on the results of a cardiac catheterization performed for clinical care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None