Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
|ClinicalTrials.gov Identifier: NCT00006058|
Recruitment Status : Completed
First Posted : July 6, 2000
Last Update Posted : June 24, 2005
I. Create a clinical sample bank of neonates with lung disease to test hypotheses regarding the pathogenesis of bronchopulmonary dysplasia (BPD).
II. Determine whether a developmental deficiency of surfactant protein B (SP-B) contributes to the occurrence of respiratory distress and BPD in these patients.
III. Study metabolic abnormalities associated with inherited deficiency of SP-B in these patients.
IV. Determine whether plasma nitrotyrosine levels, a marker of peroxynitrite mediated oxidant stress, are elevated in premature infants who develop BPD.
V. Measure the temporal changes in critical components of the inflammatory process (cell composition, inducible nitric oxide synthase, hyaluronan (HA), receptor for HA mediated mobility, and selected cytokines) in bronchoalveolar lavage, blood, and urine samples obtained from these patients, and to correlate these changes with their clinical course.
VI. Examine changes in the insulin-like growth factor axis that occur in the lungs of infants with respiratory distress syndrome (RDS) and BPD.
VII. Determine the relationship between degradation of elastin and the clinical course of BPD.
VIII. Determine whether the normal fall in plasma endothelin-1 concentrations after birth are delayed in infants with RDS and BPD.
|Condition or disease|
|Respiratory Distress Syndrome Bronchopulmonary Dysplasia|
Bronchoalveolar lavage and urine samples are obtained from patients on day of life 0, 1, 3, 7, 14, 21, and 28, and every 2 weeks thereafter until the infant is extubated. Serial blood samples are obtained from patients on day of life 0 (cord blood if possible), 1, 3, 7, 14, and 28, and prior to hospital discharge. Infants who require supplemental oxygen beyond 28 days of life will have 3 additional blood samples obtained at 6, 8, and 12 weeks of life. Those infants with established bronchopulmonary dysplasia who are admitted to the hospital at over 4 weeks of age have plasma samples obtained at the time of admission, and every 2 weeks thereafter for a maximum total of 5 samples.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns|
|Study Start Date :||September 1996|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006058
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Roberta A. Ballard||Children's Hospital of Philadelphia|