NCT00000576

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jun 1993

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1993

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

February 18, 2016

Status Verified

May 1, 2001

First QC Date

October 27, 1999

Last Update Submit

February 17, 2016

Conditions

Bronchopulmonary DysplasiaHyaline Membrane DiseaseLung Diseases

Interventions

beclomethasoneDRUG

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 10099142BACKGROUND

  • Gupta 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.

    PMID: 11015126BACKGROUND

  • Arias-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.

    PMID: 10495332BACKGROUND

  • Cole 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.

    PMID: 10393606BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary DysplasiaHyaline Membrane DiseaseLung Diseases

Interventions

Beclomethasone

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiratory Distress Syndrome, NewbornRespiratory Distress SyndromeRespiration Disorders

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

June 1, 1993

Study Completion

April 1, 1999

Last Updated

February 18, 2016

Record last verified: 2001-05