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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
Must not have
Pneumothorax
Known or suspected congenital heart disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 - 26 months corrected postnatal age
Awards & highlights
Drug Has Already Been Approved
All Individual Drugs Already Approved
Pivotal 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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a collapsed lung.
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I have a heart condition I was born with.
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I do not have severe infections.
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I have a condition that requires surgery.
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I am expected to be taken off the ventilator within 24 hours.

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

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

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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
536 Previous Clinical Trials
159,765 Total Patients Enrolled
2 Trials studying Acute Lung Injury
151 Patients Enrolled for Acute Lung Injury

Media Library

Budesonide (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05364385 — Phase 4
Acute Lung Injury Research Study Groups: S/B group- infants, S/P group- control / placebo comparator
Acute Lung Injury 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
~4 spots leftby Nov 2025
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