Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Bronchopulmonary Dysplasia Clinical Trial

— GRP  

Official title:

Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748565
• Other study ID #: Pro00025462
• Status: Completed
• Start date: May 2012
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Premature Birth
• Prematurity

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina
United States	Riley Children's Hospital	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	Indiana University, University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	day-of-life 1-4
Primary	urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	36 weeks post-menstrual age
Primary	urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	4-6 months corrected age
Primary	urine GRP levels	Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD	12-14 months corrected age
Primary	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
Primary	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