Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006058
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-07-05
Brief Title:
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES
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
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
Detailed Description:
PROTOCOL OUTLINE
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CHP-GCRC-1630 | None | None | None |
| CHP-IRB-97-1200 | None | None | None |