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NCT00006058 Clinical Trial

Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

Bronchopulmonary Dysplasia Clinical Trial

Official title:
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006058
Other study ID # NCRR-M01RR00240-1630
Secondary ID CHP-IRB-97-1200C
Status Completed
Phase N/A
First received July 5, 2000
Last updated June 23, 2005
Start date September 1996

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Premature infants with gestational age of less than 33 weeks requiring mechanical ventilation

OR

Term or near term infants, at least 33 weeks gestation, with severe respiratory distress, requiring mechanical ventilation with an FiO2 greater than 0.5 and mean airway pressure greater than 10

OR

Infants over 4 weeks old with established bronchopulmonary dysplasia requiring mechanical ventilation

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

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