Lung DiseasesNCT00005287
Late Sequelae of Bronchopulmonary Dysplasia
An observational study of Lung Diseases and Bronchopulmonary Dysplasia, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Bronchopulmonary Dysplasia
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1986to Jun 1989
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
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.
Read the 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.
- Conditions
- Lung Diseases, Bronchopulmonary Dysplasia
- Medical subject headings
- Lung Diseases, Bronchopulmonary Dysplasia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1986
- Study completionJun 1989
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005287
- Sponsor's protocol ID
- 2008
- Other IDs
- R01HL036796
- Status last verified
- Jan 2016
- First submitted
- 25 May 2000
- Last updated
- 12 Jan 2016
- Results posted
- No
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. doi: 10.1056/NEJM199012273232603.
PubMed 2247118
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Late Sequelae of Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT00005287
- Acronym / sponsor ID
- 2008
- Conditions
- Lung Diseases, Bronchopulmonary Dysplasia
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1986
- Study completion
- Jun 1989
- First posted
- 26 May 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Background: PubMed 2247118Northway 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. doi: 10.1056/NEJM199012273232603.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Bronchopulmonary Dysplasia, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005287, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.