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