Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006058
Recruitment Status : Completed
First Posted : July 6, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
National Center for Research Resources (NCRR)

Tracking Information
First Submitted Date July 5, 2000
First Posted Date July 6, 2000
Last Update Posted Date June 24, 2005
Study Start Date September 1996
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
Official Title Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns
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.

Study Type Observational
Study Design Primary Purpose: Screening
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Respiratory Distress Syndrome
  • Bronchopulmonary Dysplasia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: June¬†23,¬†2005)
200
Original Enrollment Same as current
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00006058
Other Study ID Numbers NCRR-M01RR00240-1630
CHP-IRB-97-1200
CHP-GCRC-1630
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Center for Research Resources (NCRR)
Collaborators Children's Hospital of Philadelphia
Investigators
Study Chair: Roberta A. Ballard Children's Hospital of Philadelphia
PRS Account National Center for Research Resources (NCRR)
Verification Date December 2003