Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia (GRP)

Duke University

Status: Completed

Conditions: Prematurity; Bronchopulmonary Dysplasia

Study type: Observational

Funder types: Other

Identifiers

NCT01748565

Pro00025462

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

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

Trial design

260 participants in 1 patient group

premature infants

Description:

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