Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

NCT ID: NCT01516398

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2019-03-10

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.

Conditions

Bronchopulmonary Dysplasia (BPD); Hypertension, Pulmonary

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm infants

No interventions were performed. Group consisted of preterm infants enrolled in the study.

No interventions assigned to this group

Term control infants

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

No interventions assigned to this group

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)

• Maximum Eligible Age: 30 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Christine Johnson

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Johnson, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

El Camino Hospital

Mountain View, California, United States

Lucile Packard Children's Hospital at Stanford

Palo Alto, California, United States

Countries

United States

Other Identifiers

BPD22044

Identifier Type: -

Identifier Source: org_study_id