An observational study in Bronchopulmonary Dysplasia and Prematurity, sponsored by Duke University. Completed at 2 sites in United States. Open to participants aged Up to 7 Days. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Duke University · Observational
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.
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 260 is above the median of 137 across 92 observational studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital
Exclusion Criteria:
Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Time frame: day-of-life 1-4
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Time frame: 36 weeks post-menstrual age
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Time frame: 4-6 months corrected age
urine GRP levels
Comparing urine GRP levels to urine biomarkers of oxidative stress in infants with and without BPD
Time frame: 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
Time frame: 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
Time frame: 12-14 months corrected age
This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Duke University