Inhaled Beclomethasone to Prevent Chronic Lung Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1993-06-30

Study Completion Date

1999-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Inhaled Corticosteroids for Treatment of Bronchopulmonary Dysplasia

NCT03503994

Bronchopulmonary Dysplasia

COMPLETED NA

Inhaled Ciclesonide Study in Preterm Infants

NCT06589245

Bronchopulmonary Dysplasia

RECRUITING PHASE1

Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies

NCT00551642

Lung Disease

COMPLETED PHASE3

Cytokine Change in Bronchoalveolar Lavage Fluid After Early Budesonide-Surfactant Treatment in Premature Infants

NCT00146497

Premature Infants Respiratory Distress Syndrome Chronic Lung Disease +2 more

TERMINATED PHASE4

Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia

NCT01035190

Bronchopulmonary Dysplasia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchopulmonary Dysplasia Hyaline Membrane Disease Lung Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

beclomethasone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No