Hypertension, Pulmonary Clinical Trial
Official title:
Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)
NCT number | NCT01516398 |
Other study ID # | BPD22044 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | March 10, 2019 |
Verified date | September 2021 |
Source | Stanford University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
A lung condition called bronchopulmonary dysplasia (BPD) is a major cause of poor outcomes and death for premature infants. Infants with BPD are also at high risk for pulmonary hypertension (PH)-an important contributor to their condition. Previous research has suggested that a protein in the blood, endothelin-1 (ET-1), is associated with pulmonary disease. This study aims to investigate the incidence of PH and levels of ET-1 among premature babies with BPD. It will also potentially allow us to focus further research efforts and treatment towards these infants, some of our sickest patients at LPCH.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 10, 2019 |
Est. primary completion date | March 10, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 30 Weeks |
Eligibility | Inclusion Criteria: - Premature Infants (<30 weeks EGA) Exclusion Criteria: - Major congenital malformations (cardiac, respiratory, gastrointestinal) - congenital infection, and/or - known genetic syndromes (i.e. trisomy 21) |
Country | Name | City | State |
---|---|---|---|
United States | El Camino Hospital | Mountain View | California |
United States | Lucile Packard Children's Hospital at Stanford | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Infant develops BPD | 36 weeks of age | ||
Secondary | Infant develops PH | 36 weeks |
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