Clinical trial NCT01516398: Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia
Official title: Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia (BPD)
Hypertension, Pulmonary
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2012-01-24
Enrollment: 40
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: LPCH premature neonates

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.

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.

Eligibility 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)

Primary outcomes:
measure: Infant develops BPD
timeFrame: 36 weeks of age
Secondary outcomes:
measure: Infant develops PH
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: El Camino Hospital
state: California
city: Palo Alto
country: United States
facility: Lucile Packard Children's Hospital at Stanford
state: California
Study officials:
affiliation: Stanford University
name: Christine Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: