Bronchopulmonary DysplasiaPhase 3NCT00000576
Inhaled Beclomethasone to Prevent Chronic Lung Disease
A Phase 3 study testing beclomethasone in people with Bronchopulmonary Dysplasia and Hyaline Membrane Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Bronchopulmonary Dysplasia, Hyaline Membrane Disease, Lung Diseases
- What is being tested?
- beclomethasone
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1993to Apr 1999
- Phase
- Phase 3
- 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 1 year
- All sexes
- No healthy volunteers
- Child
Premature boy and girl infants with birth weight less than 1,251 grams, gestational age less than 33 weeks, and postnatal age three to fourteen days, who continue to require mechanical ventilation with an emphasis on enrollment at three days.
About this study
To test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia.
Read the detailed description
BACKGROUND:
Bronchopulmonary dysplasia (BPD), a fibrotic/emphysematous lung disorder is a common sequela among extremely premature infants. The severity of BPD, but not incidence, has been reduced by surfactant therapy. BPD remains one of the most significant contributors to excessively prolonged hospital stays and, therefore, potentially avoidable costs. Research leading to a reduction in BPD morbidity should prove cost effective in the estimated 10,400 affected infants annually (40 percent of a projected 26,000 survivors of birthweights less than 1,250 grams).
Inflammation is a significant component of both clinical and experimental model BPD and is the subject of numerous basic science investigations begun since the empiric observation that BPD responds favorably to systemic steroids. The known side effects of systemic steroids have led to their cautious sequential controlled clinical investigation, initially for late treatment (at more than 30 days of age), then early treatment (two weeks), then very early treatment (seven days), and even prophylaxis (day one). The prophylactic clinical trial of inhaled steroids, starting at day three for 21 days, is a logical next step in this sequence of determining the least dangerous, yet effective means to prevent or treat the inflammatory components of BPD.
DESIGN NARRATIVE:
Multicenter, randomized, double-blind, placebo-controlled. The premature infants were randomized to beclomethasone or placebo on day three of life. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 micrograms per kilogram of body weight per day, for four days. The primary outcome measure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death.
Clinical sites included the Boston Perinatal Center at the New England Medical Center Hospitals, the Baystate Medical Center in Springfield, Massachusetts, and the Pennsylvania Hospital in Philadelphia. The Data Coordinating Center was at Boston University School of Medicine. Support for the trial ended in April, 1999.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Being tested
- beclomethasone
- Medical subject headings
- Bronchopulmonary Dysplasia, Hyaline Membrane Disease, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 1999 (estimated)
- Study startJun 1993
- Study completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000576
- Sponsor's protocol ID
- 214
- Other IDs
- U01HL049803
- Status last verified
- May 2001
- First submitted
- 27 Oct 1999
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Cole CH, Colton T, Shah BL, Abbasi S, MacKinnon BL, Demissie S, Frantz ID 3rd. Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia. N Engl J Med. 1999 Apr 1;340(13):1005-10. doi: 10.1056/NEJM199904013401304.
PubMed 10099142Gupta GK, Cole CH, Abbasi S, Demissie S, Njinimbam C, Nielsen HC, Colton T, Frantz ID 3rd. Effects of early inhaled beclomethasone therapy on tracheal aspirate inflammatory mediators IL-8 and IL-1ra in ventilated preterm infants at risk for bronchopulmonary dysplasia. Pediatr Pulmonol. 2000 Oct;30(4):275-81. doi: 10.1002/1099-0496(200010)30:43.0.co;2-g.
PubMed 11015126Arias-Camison JM, Lau J, Cole CH, Frantz ID 3rd. Meta-analysis of dexamethasone therapy started in the first 15 days of life for prevention of chronic lung disease in premature infants. Pediatr Pulmonol. 1999 Sep;28(3):167-74. doi: 10.1002/(sici)1099-0496(199909)28:33.0.co;2-y.
PubMed 10495332Cole CH, Shah B, Abbasi S, Demissie S, MacKinnon B, Colton T, Frantz ID 3rd. Adrenal function in premature infants during inhaled beclomethasone therapy. J Pediatr. 1999 Jul;135(1):65-70. doi: 10.1016/s0022-3476(99)70329-x.
PubMed 10393606
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Beclomethasone to Prevent Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT00000576
- Acronym / sponsor ID
- 214
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1993
- Study completion
- Apr 1999 (actual)
- First posted
- 28 Oct 1999 (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 test if inhaled glucocorticoids, early in the course of respiratory failure in premature infants, permit normal lung growth and differentiation, thus preventing development of bronchopulmonary dysplasia.
Detailed description
BACKGROUND:
Bronchopulmonary dysplasia (BPD), a fibrotic/emphysematous lung disorder is a common sequela among extremely premature infants. The severity of BPD, but not incidence, has been reduced by surfactant therapy. BPD remains one of the most significant contributors to excessively prolonged hospital stays and, therefore, potentially avoidable costs. Research leading to a reduction in BPD morbidity should prove cost effective in the estimated 10,400 affected infants annually (40 percent of a projected 26,000 survivors of birthweights less than 1,250 grams).
Inflammation is a significant component of both clinical and experimental model BPD and is the subject of numerous basic science investigations begun since the empiric observation that BPD responds favorably to systemic steroids. The known side effects of systemic steroids have led to their cautious sequential controlled clinical investigation, initially for late treatment (at more than 30 days of age), then early treatment (two weeks), then very early treatment (seven days), and even prophylaxis (day one). The prophylactic clinical trial of inhaled steroids, starting at day three for 21 days, is a logical next step in this sequence of determining the least dangerous, yet effective means to prevent or treat the inflammatory components of BPD.
DESIGN NARRATIVE:
Multicenter, randomized, double-blind, placebo-controlled. The premature infants were randomized to beclomethasone or placebo on day three of life. Beclomethasone was delivered in a decreasing dosage, from 40 to 5 micrograms per kilogram of body weight per day, for four days. The primary outcome measure was bronchopulmonary dysplasia at 28 days of age. Secondary outcomes included bronchopulmonary dysplasia at 36 weeks of postmenstrual age, the need for systemic glucocorticoid therapy, the need for bronchodilator therapy, the duration of respiratory support, and death.
Clinical sites included the Boston Perinatal Center at the New England Medical Center Hospitals, the Baystate Medical Center in Springfield, Massachusetts, and the Pennsylvania Hospital in Philadelphia. The Data Coordinating Center was at Boston University School of Medicine. Support for the trial ended in April, 1999.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
- Allocation
- Randomised
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| beclomethasone | Drug | – |
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 18 Feb 2016.
- Background: PubMed 10099142Cole CH, Colton T, Shah BL, Abbasi S, MacKinnon BL, Demissie S, Frantz ID 3rd. Early inhaled glucocorticoid therapy to prevent bronchopulmonary dysplasia. N Engl J Med. 1999 Apr 1;340(13):1005-10. doi: 10.1056/NEJM199904013401304.
- Background: PubMed 11015126Gupta GK, Cole CH, Abbasi S, Demissie S, Njinimbam C, Nielsen HC, Colton T, Frantz ID 3rd. Effects of early inhaled beclomethasone therapy on tracheal aspirate inflammatory mediators IL-8 and IL-1ra in ventilated preterm infants at risk for bronchopulmonary dysplasia. Pediatr Pulmonol. 2000 Oct;30(4):275-81. doi: 10.1002/1099-0496(200010)30:43.0.co;2-g.
- Background: PubMed 10495332Arias-Camison JM, Lau J, Cole CH, Frantz ID 3rd. Meta-analysis of dexamethasone therapy started in the first 15 days of life for prevention of chronic lung disease in premature infants. Pediatr Pulmonol. 1999 Sep;28(3):167-74. doi: 10.1002/(sici)1099-0496(199909)28:33.0.co;2-y.
- Background: PubMed 10393606Cole CH, Shah B, Abbasi S, Demissie S, MacKinnon B, Colton T, Frantz ID 3rd. Adrenal function in premature infants during inhaled beclomethasone therapy. J Pediatr. 1999 Jul;135(1):65-70. doi: 10.1016/s0022-3476(99)70329-x.
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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?
A Phase 3 study testing beclomethasone in people with Bronchopulmonary Dysplasia and Hyaline Membrane Disease, run by National Heart, Lung, and Blood Institute (NHLBI).
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 18 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 NCT00000576, which also lists 4 linked publications.
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 18 Feb 2016.