Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns - Full Text View

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

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening

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

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

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

National Center for Research Resources (NCRR)

Children's Hospital of Philadelphia

Investigators


Study Chair:	Roberta A. Ballard	Children's Hospital of Philadelphia

More Information

Study ID Numbers:	NCRR-M01RR00240-1630, CHP-IRB-97-1200, CHP-GCRC-1630
First Received:	July 5, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006058
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

Study placed in the following topic categories:

Bronchopulmonary dysplasia

Bronchopulmonary Dysplasia

Respiratory Tract Diseases

Lung Diseases

Respiration Disorders

Rare Diseases

Infant, Newborn, Diseases

Infant, Premature, Diseases

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on December 03, 2008

Sponsors and Collaborators:	National Center for Research Resources (NCRR) Children's Hospital of Philadelphia
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006058