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Corticosteroid

A (two study drugs group) for Bronchopulmonary Dysplasia

Phase 2
Waitlist Available
Led By Waleed M Maamoun, MD
Research Sponsored by East Carolina University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up supplemental oxygen requirement at 36 weeks' postmenstrual age (pma)
Awards & highlights

Study Summary

A Pilot study to evaluate the safety and the efficacy of endotracheal instillation of pulmonary surfactant, with or without topical steroid (Budesonide), as a prophylactic treatment for Bronchopulmonary Dysplasia (a form of chronic lung disease) in extremely low birth weight infants. Cytokines (a group of inflammatory mediators) are measured in the tracheal aspirate before and after instillation of the study drugs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and the measurement of cytokines in tracheal aspirate samples will be done at the end of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
Secondary outcome measures
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: A (two study drugs group)Experimental Treatment2 Interventions
The standard management + two study drugs (endotracheal instillation of a mixture containing budesonide and Infasurf)
Group II: B (one study drug group)Active Control1 Intervention
The standard management + one study drug (endotracheal instillation of Infasurf only).
Group III: C (no study drug group)Placebo Group1 Intervention
The standard management only.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Budesonide
FDA approved

Find a Location

Who is running the clinical trial?

East Carolina UniversityLead Sponsor
107 Previous Clinical Trials
38,764 Total Patients Enrolled
Waleed M Maamoun, MDPrincipal InvestigatorPitt County Memorial Hospital/Brody School of Medicine at East Carolina University
James Cummings, MDStudy DirectorPitt County Memorial Hospital/Brody School of Medicine at East Carolina University
1 Previous Clinical Trials
477 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
2010. "Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01268215.
All > Lung
~3 spots leftby Apr 2025
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