Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Indiana University | OTHER |
| University of North Carolina, Chapel Hill | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| premature infants | Infants born prematurely between 23-0/7 and 27-6/7 weeks post-menstrual age with and without bronchopulmonary dysplasia |
Not provided
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients in the neonatal intensive care unit at Duke Medical Center or Riley Children's Hospital
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Charles M Cotten, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riley Children's Hospital | Indianapolis | Indiana | 46202-5225 | United States | ||
| Duke University Medical Center |
Not provided
| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
urine specimens and saliva with DNA
| Durham |
| North Carolina |
| 27710 |
| United States |
| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |