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Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease

NCT05364385 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2022-11-01

No results posted yet for this 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.

Conditions

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

Interventions

DRUG

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

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

DRUG

Infants in the control group (S/P group) receive placebo (Normal saline 1mL)

Infants in the control group (S/P group) will receive surfactant 2.5 mls/kg and placebo (Normal saline 1mL)

Sponsors & Collaborators

  • University of Arizona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
18 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2023-02-28
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364385 on ClinicalTrials.gov