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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00005287
Other study ID # 2008
Secondary ID R01HL036796
Status Completed
Phase N/A
First received May 25, 2000
Last updated January 8, 2016
Start date July 1986
Est. completion date June 1989

Study information

Verified date January 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date June 1989
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A to 100 Years
Eligibility No eligibility criteria

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Stanford University National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

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. — View Citation

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