Infant, Extremely PrematurePhase 4STOPCLDNCT05364385
Intra-tracheal Instillation of Budesonide to Prevent Chronic Lung Disease
A Phase 4 study testing Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) in people with Infant, Extremely Premature and Acute Lung Injury, run by University of Arizona at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 hours
- Conditions the study is for
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity
- What is being tested?
- Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2019to Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- major congenital defects
- chromosomal abnormality
- pneumothorax
- Known surgical disease
- Known or suspected congenital heart disease
- Infant not considered viable by physician
- Severe sepsis / infections
- Likely to be extubated within the next 24 hours
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona
Tucson, Arizona, 85719
Joanna Schrader, 520-626-6282, jschrader@arizona.edu
About this study
Official title: Intra-tracheal Instillation of Budesonide Along With Surfactant in Preterm Infants to Prevent Chronic Lung Disease
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.
Read the detailed description
In extremely premature infants who are ventilated there is ongoing lung injury \& lung inflammation. This can perpetuate the need for ongoing ventilation and these infants spend much longer in the hospital. The likelihood of chronic lung disease in this susceptible group is very high and they would need oxygen at home. Surfactant instillation has reduced the need for prolonged mechanical ventilation and to an extent the incidence of chronic lung disease (CLD). But many infants develop CLD and need prolonged oxygen treatment, diuretics and inhaled steroids to suppress the inflammation and obstruction of the airways. Some of the severely affected infants need orally administered steroids. The Inestigators propose to provide a dose of steroids instilled along with the surfactant in the very first day of life so as to prevent the vicious and ongoing cascade of lung injury and inflammation. As it is a poorly absorbed steroid and as only one or two doses is proposed to be used there is no effects within the body and it works locally within the lung. This is hoped to reduce CLD and improve long term outcomes. The population most susceptible to CLD is the extreme preterm infant with RDS who needs mechanical ventilation soon after birth. One of the groups will receive the surfactant with saline and the other group will receive the surfactant along with topical steroid. The groups will be followed during the hospital stay. survival along with duration of ventilation, duration of hospital stay and oxygen needs are noted. To study the hoped for long term benefits the investigators would note the long term neuro-development - if they were followed as per hospital policy between 18 months and 26 months. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation.
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Being tested
- 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)
- Medical subject headings
- Acute Lung Injury, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)Drug
Also called Pulmicort
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)Drug
Infants in the control group (S/P group) will receive surfactant 2.5 mls/kg and placebo (Normal saline 1mL)
| Study group | Role | What they receive |
|---|---|---|
| S/B group- infants | Experimental | Infants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL Receives: Drug: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) |
| S/P group- control / placebo comparator | Placebo comparator | Infants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL) Receives: Drug: Infants in the control group (S/P group) receive placebo (Normal saline 1mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of combined inflammatory cytokines
Change in inflammatory cytokines /chemokines (interleukin-6, 8, 10 and Tumor Necrosis Factor α (TNF-α) levels
Measured: 4 weeks
Secondary outcomes (4)
chronic lung disease
Supplemental oxygen requirement at 36 weeks corrected gestational age
Measured: 36 weeks corrected gestational age (CGA)
Mortality
All cause mortality
Measured: upto 40 weeks corrected gestational age (CGA)
Ventilator days
duration of ventilation
Measured: Upto 40 weeks corrected gestational age (CGA)
Neuro-developmental outcome
Composite Bailey III neuro-developmental score. Scores range overall from 40 to 160 and for Cognitive: 55-145; Language: 47-153; Motor: 46-154; Social-Emotional: 55-145 with lower score for poor outcome and higher score for better outcome
Measured: 18 - 26 months corrected postnatal age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start2 Dec 2019
- Primary completionFeb 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Extremely PrematureStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364385
- Sponsor's protocol ID
- 1811108822
- Acronym
- STOPCLD
- Status last verified
- Oct 2022
- First submitted
- 2 May 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-tracheal Instillation of Budesonide Along With Surfactant in Preterm Infants to Prevent Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT05364385
- Acronym / sponsor ID
- STOPCLD / 1811108822
- Conditions
- Infant, Extremely Premature, Acute Lung Injury, Chronic Lung Disease of Prematurity, Budesonide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In extremely premature infants who are ventilated there is ongoing lung injury \& lung inflammation. This can perpetuate the need for ongoing ventilation and these infants spend much longer in the hospital. The likelihood of chronic lung disease in this susceptible group is very high and they would need oxygen at home. Surfactant instillation has reduced the need for prolonged mechanical ventilation and to an extent the incidence of chronic lung disease (CLD). But many infants develop CLD and need prolonged oxygen treatment, diuretics and inhaled steroids to suppress the inflammation and obstruction of the airways. Some of the severely affected infants need orally administered steroids. The Inestigators propose to provide a dose of steroids instilled along with the surfactant in the very first day of life so as to prevent the vicious and ongoing cascade of lung injury and inflammation. As it is a poorly absorbed steroid and as only one or two doses is proposed to be used there is no effects within the body and it works locally within the lung. This is hoped to reduce CLD and improve long term outcomes. The population most susceptible to CLD is the extreme preterm infant with RDS who needs mechanical ventilation soon after birth. One of the groups will receive the surfactant with saline and the other group will receive the surfactant along with topical steroid. The groups will be followed during the hospital stay. survival along with duration of ventilation, duration of hospital stay and oxygen needs are noted. To study the hoped for long term benefits the investigators would note the long term neuro-development - if they were followed as per hospital policy between 18 months and 26 months. Intra-tracheal instillation of budesonide using surfactant as vehicle would facilitate its delivery to the periphery of the lung and would inhibit lung inflammation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S/B group- infants | Experimental | Drug: Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)Infants randomized to the study group (S/B group) will receive surfactant and Budesonide - 0.5 mg -1mL |
| S/P group- control / placebo comparator | Placebo comparator | Drug: Infants in the control group (S/P group) receive placebo (Normal saline 1mL)Infants randomized to the control group (S/P group) will receive surfactant and placebo (Normal Saline -1mL) |
Who may qualify
- Ages
- Up to 18 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- major congenital defects
- chromosomal abnormality
- pneumothorax
- Known surgical disease
- Known or suspected congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL)Also: PulmicortInfants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) | Drug | S/B group- infants |
| 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) | Drug | S/P group- control / placebo comparator |
Primary outcome
Change of combined inflammatory cytokines
Time frame: 4 weeks
Change in inflammatory cytokines /chemokines (interleukin-6, 8, 10 and Tumor Necrosis Factor α (TNF-α) levels
4 secondary outcomes
chronic lung disease
Time frame: 36 weeks corrected gestational age (CGA)
Mortality
Time frame: upto 40 weeks corrected gestational age (CGA)
Ventilator days
Time frame: Upto 40 weeks corrected gestational age (CGA)
Neuro-developmental outcome
Time frame: 18 - 26 months corrected postnatal age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infants in the study group (S/B group) will receive surfactant 2.5 mls/kg and Budesonide 0.5 mg (1mL) in people with Infant, Extremely Premature and Acute Lung Injury, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R Kylat, MD (5206266627, rkylat@arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of combined inflammatory cytokines (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.