Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia (GRP)

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.

Study Overview

• Status: Completed
• Conditions: Bronchopulmonary Dysplasia; Prematurity

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
• Enrollment (Actual): 260

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202-5225
      • Riley Children's Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	day-of-life 1-4
urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	36 weeks post-menstrual age
urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	4-6 months corrected age
urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	12-14 months corrected age
infant pulmonary function tests	The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD	4-6 months corrected age
infant pulmonary function tests	The association of urine GRP levels and the severity of lung disease as determined by pulmonary function tests in infants with and without BPD	12-14 months corrected age

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: University of North Carolina, Chapel Hill; Indiana University
• Investigators: Principal Investigator: Charles M Cotten, MD, Duke University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: December 11, 2012
• First Posted (Estimated): December 12, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: biomarkers; prematurity; oxidative stress; BPD
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Premature Birth; Bronchopulmonary Dysplasia
• Other Study ID Numbers: Pro00025462