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
  Purpose

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.


Condition
Bronchopulmonary Dysplasia (BPD)
Pulmonary Hypertension (PH)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Endothelin-1 (ET-1) and Brain Natriuretic Peptide (BNP) 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant develops PH [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 30 Weeks
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516398

Locations
United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01516398     History of Changes
Other Study ID Numbers: BPD22044
Study First Received: January 19, 2012
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014