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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date September 2021
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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)

Study Design


Locations

Country Name City State
United States El Camino Hospital Mountain View California
United States Lucile Packard Children's Hospital at Stanford Palo Alto California

Sponsors (1)

Lead Sponsor Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

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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