Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

NCT ID: NCT01748565

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 260 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2016-08-31

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.

Conditions

Bronchopulmonary Dysplasia; Prematurity

Study Design

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

Study Groups

premature infants

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

No interventions assigned to this group

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

• Maximum Eligible Age: 7 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles M Cotten, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Riley Children's Hospital

Indianapolis, Indiana, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00025462

Identifier Type: -

Identifier Source: org_study_id