Inhaled Beclomethasone to Prevent Chronic Lung Disease

Brief Title

Inhaled Beclomethasone to Prevent Chronic Lung Disease

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 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 Phase

Phase 3

Study Type

Interventional

Condition

Bronchopulmonary Dysplasia

Intervention

beclomethasone

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Start Date

June 1993

Completion Date

April 1999

Eligibility 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.

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

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Administrative Informations

NCT ID

NCT00000576

Organization ID

Secondary IDs

U01HL049803

Study Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

, ,

Verification Date

May 2001