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Clinical Trials/NCT00006058
NCT00006058
Completed
Not Applicable

Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

National Center for Research Resources (NCRR)1 site in 1 country200 target enrollmentSeptember 1996

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome
Sponsor
National Center for Research Resources (NCRR)
Enrollment
200
Locations
1
Status
Completed
Last Updated
20 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1996
End Date
TBD
Last Updated
20 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
National Center for Research Resources (NCRR)

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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