- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00005287
Late Sequelae of Bronchopulmonary Dysplasia
Study Overview
Status
Conditions
Detailed Description
BACKGROUND:
Eleven to 22 percent of prematurely born human infants with Respiratory Distress Syndrome (RDS) treated with artificial ventilation and supplemental oxygen therapy, develop a severe chronic lung disease called bronchopulmonary dysplasia. While many children who had BPD are asymptomatic by three years of age, some can have respiratory symptoms and abnormal pulmonary function tests at nine years of age. The hypothesis tested in this study is that abnormalities of pulmonary function seen in infants with BPD can persist into adolescence, even in asymptomatic children and young adults.
DESIGN NARRATIVE:
A detailed interval pulmonary history was taken. Pulmonary abnormalities were determined by pulmonary angiography and lateral chest x-ray and pulmonary function tests for small airway obstruction, reversible bronchial hyperreactivity, distribution of ventilation, air trapping and hyperinflation, residual interstitial disease or edema, vascular bed loss, and gas exchange. Right and left ventricular hypertrophy were evaluated by electrocardiogram. Elevated right ventricular pressure was estimated by echocardiography with doppler ultrasound. The atopic status of the children was determined. Other abnormalities, including growth retardation, developmental delay, hearing loss, retrolental fibroplasia, and neurologic disability seen in BPD were assessed by history and physical examination.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008 (Ministry of Health)
- R01HL036796 (U.S. NIH Grant/Contract)
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