Late Sequelae of Bronchopulmonary Dysplasia

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00005287
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Duration (Months): 35

Study Details

Study Description

Brief Summary

To measure the cardiopulmonary function in individuals who developed bronchopulmonary dysplasia (BPD) at Stanford University Medical Center from 1964-1973 and to determine the factors associated with the presence of cardiopulmonary function abnormalities in these adolescents and young adults.

Condition or Disease	Intervention/Treatment	Phase
Lung Diseases; Bronchopulmonary Dysplasia

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 Design

• Study Type: Observational
• Study Start Date: Jul 1, 1986
• Study Completion Date: Jun 1, 1989

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 100 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

No eligibility criteria

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Stanford University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Northway WH Jr, Moss RB, Carlisle KB, Parker BR, Popp RL, Pitlick PT, Eichler I, Lamm RL, Brown BW Jr. Late pulmonary sequelae of bronchopulmonary dysplasia. N Engl J Med. 1990 Dec 27;323(26):1793-9.

• ClinicalTrials.gov Identifier: NCT00005287
• Other Study ID Numbers: 2008; R01HL036796
• First Posted: May 26, 2000
• Last Update Posted: Jan 12, 2016
• Last Verified: Jan 1, 2016

• Additional relevant MeSH terms: Lung Diseases; Bronchopulmonary Dysplasia

Study Results

No Results Posted as of Jan 12, 2016