Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

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Brief Title

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Official Title

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Brief Summary

      The purpose of this study is to identify biological markers that might predict premature
      infants who are at a higher risk for developing BPD, and to correlate the presence of these
      markers with infant symptoms and lung function in the first year after discharge from the
      hospital.
    

Detailed Description

      Bronchopulmonary dysplasia (BPD) is a common form of lung injury that can be triggered by
      premature birth and the unavoidable exposures to treatments regularly used for premature
      infants,including mechanical ventilation and oxygen as well as conditions that occur
      frequently among premature infants including infection. Almost all infants who are born
      prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop
      at least one infection; however, not all premature infants will develop BPD. There is
      currently no way to identify those infants who are at risk for developing BPD, nor are there
      prognostic or diagnostic tests to determine the severity of lung disease in the first year
      after discharge from the hospital.

      The application of UPLC-tandem mass spectrometry for quantification of urinary biomarkers of
      oxidative stress is an important technical innovation that will permit sensitive and
      reproducible analyses of urinary biomarkers with minimal sample preparation to better define
      disease phenotypes. Establishing a direct correlation between biomarkers of oxidative stress
      and GRP will accelerate investigation into the mechanisms leading to chronic pediatric lung
      disease and childhood origins of pulmonary disease.
    


Study Type

Observational


Primary Outcome

urine GRP levels


Condition

Bronchopulmonary Dysplasia


Study Arms / Comparison Groups

 premature infants
Description:  Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia

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

260

Start Date

May 2012

Completion Date

August 2016

Primary Completion Date

August 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age

        Exclusion Criteria:

          -  Are not considered to be viable (decision made not to provide life-saving therapies)

          -  Have congenital heart disease (not including PDA and hemodynamically insignificant VSD
             or ASD)

          -  Have structural abnormalities of the upper airway, lungs or chest wall

          -  Have other congenital malformations or syndromes that adversely affect life expectancy
             or cardio-pulmonary development

          -  Unlikely to return to the clinic for follow-up visits
      

Gender

All

Ages

N/A - 7 Days

Accepts Healthy Volunteers

No

Contacts

Charles M Cotten, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01748565

Organization ID

Pro00025462


Responsible Party

Sponsor

Study Sponsor

Duke University

Collaborators

 Indiana University

Study Sponsor

Charles M Cotten, MD, Principal Investigator, Duke University


Verification Date

August 2016