Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

This study has been completed.
Sponsor:
Collaborator:
Children's Hospital of Philadelphia
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006058
First received: July 5, 2000
Last updated: June 23, 2005
Last verified: December 2003
  Purpose

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.


Condition
Respiratory Distress Syndrome
Bronchopulmonary Dysplasia

Study Type: Observational
Study Design: Primary Purpose: Screening
Official Title: Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 200
Study Start Date: September 1996
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006058

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Study Chair: Roberta A. Ballard Children's Hospital of Philadelphia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006058     History of Changes
Other Study ID Numbers: NCRR-M01RR00240-1630, CHP-IRB-97-1200, CHP-GCRC-1630
Study First Received: July 5, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):
bronchopulmonary dysplasia
cardiovascular and respiratory diseases
neonatal disorders
rare disease
respiratory distress syndrome

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Bronchopulmonary Dysplasia
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Ventilator-Induced Lung Injury
Lung Injury

ClinicalTrials.gov processed this record on September 18, 2014