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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Christine Johnson, Stanford University Identifier:
First received: January 19, 2012
Last updated: October 12, 2016
Last verified: October 2016

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.

Bronchopulmonary Dysplasia (BPD)
Hypertension, Pulmonary

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Infant develops BPD [ Time Frame: 36 weeks of age ]

Secondary Outcome Measures:
  • Infant develops PH [ Time Frame: 36 weeks ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed 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.


Ages Eligible for Study:   up to 30 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
LPCH premature neonates

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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01516398

United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
Principal Investigator: Christine Johnson, MD Stanford University
  More Information

Responsible Party: Christine Johnson, Principle Investigator, Stanford University Identifier: NCT01516398     History of Changes
Other Study ID Numbers: BPD22044
Study First Received: January 19, 2012
Last Updated: October 12, 2016
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Publication

Additional relevant MeSH terms:
Hypertension, Pulmonary
Bronchopulmonary Dysplasia
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases processed this record on April 28, 2017