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):
Stanford University
ClinicalTrials.gov Identifier:
NCT01516398
First received: January 19, 2012
Last updated: January 7, 2014
Last verified: January 2014

January 19, 2012
January 7, 2014
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 ]
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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 ]
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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
Endothelin-1 (ET-1) and Brain Natriuretic Peptide (BNP) 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 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; 2) investigate ET-1 levels in infants with BPD-associated PH versus those without BPD-associated PH; and 3) investigate BNP (brain natriuretic peptide) values 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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

LPCH premature neonates

  • Bronchopulmonary Dysplasia (BPD)
  • Pulmonary Hypertension (PH)
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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
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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
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01516398
BPD22044
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Stanford University
Stanford University
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Stanford University
January 2014

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