Study of the Pathobiology of Bronchopulmonary Dysplasia in Newborns

NCT00006058 | Completed

• 3 other identifiers: NCRR-M01RR00240-1630CHP-IRB-97-1200CHP-GCRC-1630
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasia; cardiovascular and respiratory diseases; neonatal disorders; rare disease; respiratory distress syndrome

Eligibility Criteria

• Age: 0 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Bronchopulmonary Dysplasia; Respiratory Tract Diseases; Infant, Newborn, Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Lung Diseases; Respiration Disorders; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roberta A. Ballard

  Children's Hospital of Philadelphia

  STUDY CHAIR

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: July 5, 2000
• First Posted: July 6, 2000
• Study Start: September 1, 1996
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)