Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

Hypertension, Pulmonary Clinical Trial

Official title:

Endothelin-1 (ET-1) Levels as Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia (BPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01516398
• Other study ID #: BPD22044
• Status: Completed
• Start date: July 2011
• Est. completion date: March 10, 2019

Study information

• Verified date: September 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 10, 2019
• Est. primary completion date: March 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Weeks

Eligibility

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)

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Bronchopulmonary Dysplasia (BPD)
• Hypertension
• Hypertension, Pulmonary

Locations

Country	Name	City	State
United States	El Camino Hospital	Mountain View	California
United States	Lucile Packard Children's Hospital at Stanford	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant develops BPD		36 weeks of age
Secondary	Infant develops PH		36 weeks