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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Christine Johnson, Stanford University
ClinicalTrials.gov Identifier:
NCT01516398
First received: January 19, 2012
Last updated: October 12, 2016
Last verified: October 2016

January 19, 2012
October 12, 2016
July 2011
June 2013   (final data collection date for primary outcome measure)
Infant develops BPD [ Time Frame: 36 weeks of age ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01516398 on ClinicalTrials.gov Archive Site
Infant develops PH [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Not Provided
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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
LPCH premature neonates
  • Bronchopulmonary Dysplasia (BPD)
  • Hypertension, Pulmonary
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
June 2017
June 2013   (final data collection date for primary outcome measure)

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)
Both
up to 30 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516398
BPD22044
No
Yes
Publication
Christine Johnson, Stanford University
Stanford University
Not Provided
Principal Investigator: Christine Johnson, MD Stanford University
Stanford University
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP