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Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

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Stanford University

Status

Completed

Conditions

Bronchopulmonary Dysplasia (BPD)
Hypertension, Pulmonary

Study type

Observational

Funder types

Other

Identifiers

NCT01516398
BPD22044

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

All

Ages

Under 30 weeks old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

40 participants in 2 patient groups

Preterm infants
Description:
No interventions were performed. Group consisted of preterm infants enrolled in the study.
Term control infants
Description:
No interventions were performed. Group consisted of term infants enrolled in the study to serve as controls for the preterm infant group.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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