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Corticosteroid

Intra-tracheal Budesonide for Bronchopulmonary Dysplasia (STOPCLD Trial)

Phase 4
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 - 26 months corrected postnatal age
Awards & highlights

STOPCLD Trial Summary

This trial is testing whether using budesonide to treat preterm infants' lungs will help reduce inflammation and lung injury.

Who is the study for?
This trial is for preterm infants born before 30 weeks of gestation or weighing less than 1500 grams, who are experiencing severe respiratory distress syndrome. Infants must require mechanical ventilation and have specific clinical and radiologic signs. Those with major birth defects, chromosomal abnormalities, heart disease, conditions requiring imminent extubation, pneumothorax, surgical diseases or severe infections cannot participate.Check my eligibility
What is being tested?
The study is testing whether intra-tracheal budesonide can prevent chronic lung disease in premature infants with acute lung injury. Infants will be randomly assigned to receive either a combination of surfactant and budesonide directly into the trachea or a placebo saline solution.See study design
What are the potential side effects?
Potential side effects from budesonide may include irritation at the administration site within the trachea, possible hormonal imbalances due to steroid exposure (though rare), and an increased risk of infection due to immune system suppression.

STOPCLD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My baby was born very early or very small and has severe breathing problems.

STOPCLD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 - 26 months corrected postnatal age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 - 26 months corrected postnatal age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of combined inflammatory cytokines
Secondary outcome measures
Mortality
Neuro-developmental outcome
Ventilator days
+1 more

STOPCLD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: S/B group- infantsExperimental Treatment1 Intervention
Infants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL
Group II: S/P group- control / placebo comparatorPlacebo Group1 Intervention
Infants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL)

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
514 Previous Clinical Trials
148,569 Total Patients Enrolled

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05364385 — Phase 4
Bronchopulmonary Dysplasia Research Study Groups: S/B group- infants, S/P group- control / placebo comparator
Bronchopulmonary Dysplasia Clinical Trial 2023: Budesonide Highlights & Side Effects. Trial Name: NCT05364385 — Phase 4
Budesonide (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05364385 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently opportunities for patient participation in this clinical trial?

"Based on the information available via clinicaltrials.gov, this trial is actively recruiting participants. It was first advertised in December 2nd 2019 and has been recently updated as of October 31st 2022."

Answered by AI

What potential hazards have been identified for those participating in the study group who will be administered surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)?

"Analysts at Power have assigned a rating of 3 out of 3 to Infants in the S/B group, as they will be prescribed surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL), which is an approved treatment according to Phase 4 clinical trials."

Answered by AI

What is the cohort size of this clinical exploration?

"Affirmative. The clinicaltrials.gov website shows that this trial is actively searching for participants, with the initial posting on December 2nd 2019 and most recent edit being October 31st 2022. 25 individuals are needed from a single site as part of the recruitment process."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
2019. "Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05364385.
All > Lung Disease
~5 spots leftby Apr 2025
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