Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Completed

• Conditions: Bronchopulmonary Dysplasia; Prematurity

• Registration Number: NCT01748565
• Lead Sponsor: Duke University

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-12
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
urine GRP levels	12-14 months corrected age	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
infant pulmonary function tests	12-14 months corrected age	The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD

Trial Locations

Locations (2)

Riley Children's Hospital; 🇺🇸 Indianapolis, Indiana, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States