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Home > "S" Clinical Trials Conditions > Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns  Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
For Condition: Respiratory Distress Syndrome,Bronchopulmonary Dysplasia
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , Children's Hospital of Philadelphia
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 200
Location and Contact Information:
Overall Study Official:
RobertaBallard, Study Chair, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Additional Information:
Study ID Numbers: NCRR-M01RR00240-1630; CHP-IRB-97-1200,CHP-GCRC-1630
Study Start Date: September 1996
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006058
Other Respiratory Distress Syndrome Studies:
1. Phase III Randomized, Double-Blind, Placebo-Controlled Study of Antenatal Thyrotropin-Releasing Hormone in Pregnant Women with Threatened Premature Delivery
2. Inhaled Nitric Oxide Study for Respiratory Failure in Newborns.
3. Early Inhaled Nitric Oxide for Respiratory Failure in Newborns
4. High Frequency Ventilation in Premature Infants (HIFI)
5. Minimal Breathing Support and Early Steroids to Prevent Chronic Lung Disease in Extremely Premature Infants (SAVE)
Related Studies:
Other Respiratory Distress Syndrome Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
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