Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01516398|
Recruitment Status : Recruiting
First Posted : January 24, 2012
Last Update Posted : May 1, 2018
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.
|Condition or disease|
|Bronchopulmonary Dysplasia (BPD) Hypertension, Pulmonary|
This study aims to 1) investigate the incidence of PH among premature infants with BPD versus those without BPD and 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH. This study will allow us to help define a high-risk population at LPCH—namely, premature infants with BPD-associated PH. It will also potentially allow us to focus further research efforts and treatment targets towards these infants who encompass some of our sickest patients at LPCH.
In 2009 the Division of Lung Diseases of the National Heart, Lung and Blood Institute (NHLBI) published seven priority areas for research in pediatric pulmonary diseases, one of which was pulmonary vascular disease. An emphasis was made on finding 'clinical strategies that anticipate the development of PH [which] may allow earlier recognition and more aggressive therapy, thereby slowing the development of PH in many chronic lung parenchymal and vascular diseases'. This study attempts to address this goal. Specifically we aim to evaluate ET-1 levels in premature infants diagnosed with BPD and with BPD-associated PH. If ET-1 levels are found to correlate with disease state the possibility of prediction and possible early treatment for PH in these infants is raised and merits investigation.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)|
|Actual Study Start Date :||July 2011|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
- Infant develops BPD [ Time Frame: 36 weeks of age ]
- Infant develops PH [ Time Frame: 36 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516398
|Contact: Christine Johnson, MD||650 firstname.lastname@example.org|
|Contact: Ritue Chitkara, MD||650 email@example.com|
|United States, California|
|El Camino Hospital||Recruiting|
|Mountain View, California, United States, 94040|
|Principal Investigator: Christine L Johnson, MD|
|Lucile Packard Children's Hospital at Stanford||Active, not recruiting|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Christine Johnson, MD||Stanford University|