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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

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ClinicalTrials.gov Identifier: NCT01516398
Recruitment Status : Active, not recruiting
First Posted : January 24, 2012
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.


Condition or disease
Bronchopulmonary Dysplasia (BPD) Hypertension, Pulmonary

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.


Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
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)
Study Start Date : July 2011
Primary Completion Date : June 2013
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01516398


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

Responsible Party: Christine Johnson, Principle Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT01516398     History of Changes
Other Study ID Numbers: BPD22044
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publication

Additional relevant MeSH terms:
Hypertension
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