Predictors of Pulmonary Hypertension Risk in Premature Infants With Bronchopulmonary Dysplasia

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Brief Title

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)

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.
    


Study Type

Observational


Primary Outcome

Infant develops BPD

Secondary Outcome

 Infant develops PH

Condition

Bronchopulmonary Dysplasia (BPD)



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

60

Start Date

July 2011

Completion Date

January 2022

Primary Completion Date

January 2022

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)
      

Gender

All

Ages

N/A - 30 Weeks

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Christine Johnson, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01516398

Organization ID

BPD22044


Responsible Party

Principal Investigator

Study Sponsor

Stanford University


Study Sponsor

Christine Johnson, MD, Principal Investigator, Stanford University


Verification Date

September 2019