Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000576
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
1999-10-27
Brief Title:
Inhaled Beclomethasone to Prevent Chronic Lung Disease
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
BACKGROUND
Bronchopulmonary dysplasia BPD a fibroticemphysematous 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 10400 affected infants annually 40 percent of a projected 26000 survivors of birthweights less than 1250 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
Bronchopulmonary dysplasia BPD a fibroticemphysematous 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 10400 affected infants annually 40 percent of a projected 26000 survivors of birthweights less than 1250 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL049803 | NIH | None | httpsreporternihgovquickSearchU01HL049803 |