Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) for Acute Lung Injury

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
University of Arizona, Tucson, AZ
Acute Lung Injury+6 More
Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) - Drug
Eligibility
< 18
All Sexes
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Study Summary

Preterm infants are randomized to received either Intra-tracheal instillation of budesonide using surfactant as vehicle or a placebo. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation and mitigate acute lung injury.

Eligible Conditions

  • Acute Lung Injury
  • Budesonide
  • Infants, Extremely Premature
  • Chronic Lung Disease of Prematurity

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 18 - 26 months corrected postnatal age

Month 26
Neuro-developmental outcome
Week 36
chronic lung disease
4 weeks
Change of combined inflammatory cytokines
Week 40
Ventilator days
Week 40
Mortality

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

S/B group- infants
1 of 2
S/P group- control / placebo comparator
1 of 2
Experimental Treatment
Non-Treatment Group

25 Total Participants · 2 Treatment Groups

Primary Treatment: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) · Has Placebo Group · Phase 4

S/B group- infants
Drug
Experimental Group · 1 Intervention: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) · Intervention Types: Drug
S/P group- control / placebo comparator
Drug
PlaceboComparator Group · 1 Intervention: Infants in the control group (S/P group) receive placebo (Normal saline 1mL) · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 18 - 26 months corrected postnatal age
Closest Location: University of Arizona · Tucson, AZ
Photo of az university of arizona 1Photo of az university of arizona 2Photo of tucson 3
2002First Recorded Clinical Trial
4 TrialsResearching Acute Lung Injury
240 CompletedClinical Trials

Who is running the clinical trial?

University of ArizonaLead Sponsor
447 Previous Clinical Trials
154,002 Total Patients Enrolled
2 Trials studying Acute Lung Injury
151 Patients Enrolled for Acute Lung Injury

Eligibility Criteria

Age < 18 · All Participants · 1 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.