Recruiting

Budesonide

Sponsor:

University of Arizona

Code:

NCT05364385

Conditions

Infant, Extremely Premature

Acute Lung Injury

Chronic Lung Disease of Prematurity

Budesonide

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief 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

Study ID

NCT05364385

Start date

Dec 2, 2019

Status verified date

Oct, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Feb, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Infants born at < 30+0/7 weeks (23+0 - 29+6/7) gestational age (GA) OR with preterm infants with a birth weight (BW) which is < 1500 gm AND if they have severe respiratory distress syndrome (RDS) (Clinical diagnosis based on the need for mechanical ventilation in preterm infant or if they have radiologic features of RDS along with need for positive distending airway pressure and fractional inspired oxygen (FiO2) > 0.3)

Exclusion Criteria:

1. major congenital defects
2. chromosomal abnormality
3. pneumothorax
4. Known surgical disease
5. Known or suspected congenital heart disease
6. Infant not considered viable by physician
7. Severe sepsis / infections
8. Likely to be extubated within the next 24 hours

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: S/B group- infants

Infants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL

placebo comparator: S/P group- control / placebo comparator

Infants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL)

Interventions

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)

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)

Primary outcome measure

  • Change of combined inflammatory cytokines [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

R Kylat, MD

5206266627rkylat@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85719

Contacts

Joanna Schrader

520-626-6282jschrader@arizona.edu

More Information

Sponsor

University of Arizona

Last update posted

Nov 1, 2022

Last verified

Oct, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2022-11-01.