An observational study in Bronchopulmonary Dysplasia (BPD) and Hypertension, Pulmonary, sponsored by Stanford University. Completed at 2 sites in United States. Open to participants aged Up to 30 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Stanford University · 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.
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 40 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.
Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
LPCH premature neonates
Exclusion Criteria:
No interventions were performed. Group consisted of preterm infants enrolled in the study.
No interventions were performed. Group consisted of term infants enrolled in the study to serve as controls for the preterm infant group.
Infant develops BPD
Time frame: 36 weeks of age
Infant develops PH
Time frame: 36 weeks
Plan to share: Yes — Publication
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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Stanford University