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Corticosteroid
Pilot Study of Topical Steroid for Prevention of Chronic Lung Disease in Extremely Premature Infants.
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
All Individual Drugs Already Approved
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.
Eligible Conditions
- Bronchopulmonary Dysplasia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the measurement of cytokines in tracheal aspirate samples will be done at the end of the study.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
To measure the effect of surfactant with and without Budesonide on the development of BPD in ELBW infants.
Secondary study objectives
To measure the effect of surfactant with and without Budesonide on the inflammatory cytokines in tracheal aspirates.
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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
109 Previous Clinical Trials
39,138 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
7 Previous Clinical Trials
10,886 Total Patients Enrolled
Scott MacGilvray, MDStudy ChairPitt County Memorial Hospital/Brody School of Medicine at East Carolina University
Karl Kaminski, RRT-NPSStudy ChairPitt County Memorial Hospital/Brody School of Medicine at East Carolina University