Clinical trial NCT01748565: Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia
Official title: Gastrin-Releasing Peptide and Bronchopulmonary Dysplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchopulmonary Dysplasia
Prematurity
Keywords: biomarkers
oxidative stress
BPD
prematurity
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Indiana University
name: University of North Carolina, Chapel Hill
First posted: 2012-12-12
Enrollment: 260
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital

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.

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

Primary outcomes:
measure: urine GRP levels
timeFrame: day-of-life 1-4
measure: urine GRP levels
timeFrame: 36 weeks post-menstrual age
measure: urine GRP levels
timeFrame: 4-6 months corrected age
measure: urine GRP levels
timeFrame: 12-14 months corrected age
measure: infant pulmonary function tests
timeFrame: 4-6 months corrected age
measure: infant pulmonary function tests
timeFrame: 12-14 months corrected age
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Riley Children's Hospital
state: Indiana
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Charles M Cotten, MD
role: PRINCIPAL_INVESTIGATOR
References: