Bronchopulmonary DysplasiaPhase 2NCT01895075
Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
A Phase 2 study testing Inhaled budesonide and Normal saline in people with Bronchopulmonary Dysplasia, run by Dr. Michael Dunn at 1 site in Canada.
Trial summary
Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants with a high incidence and significant impact on resource utilization and long-term outcome. Read more about this study
- Who is it for?
- Ages 14 to 42 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Inhaled budesonide and Normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2019to 1 Sep 2020
- Phase
- Phase 2
- 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 14 to 42 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spontaneous breathing preterm Infants on day 14 to day 42 of age
- Born at < 30 0/7 weeks gestational age
- Requiring FiO2 ≥ 25% on CPAP including biphasic CPAP or high flow nasal canula
Who cannot join
- Presence of chromosomal defects or major congenital anomalies
- Presence of severe infections including sepsis, meningitis, pneumonia, systemic fungal infections
- History of administration of systemic corticosteroids for pulmonary problems, not including that for hypotension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants with a high incidence and significant impact on resource utilization and long-term outcome. Systemic corticosteroids have been shown to be effective in the prevention of BPD through their potent anti-inflammatory effects but there are serious concerns on their potential detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids administered to ventilated infants are thought to be safer due to their topical effect but have not been shown to improve outcomes including BPD. To date, there have been few studies evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot trial to examine the impact of inhaled budesonide on non-ventilated infants.
The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a small cohort of preterm infants.
Read more
This will be a single-center randomized double-blind controlled pilot trial. We will recruit a total of 50 infants born at less than 30 weeks gestation who are on continuous positive airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later. Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7 weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD, re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse outcomes.
The prevention of BPD would have a significant positive impact on patient quality of life and medical resource utilization and costs. The study hypothesis is that inhaled budesonide on non-ventilated infants with early signs of BPD will reduce the 'days on supplemental oxygen' indicating a positive effect for the prevention of BPD. The result of this pilot study might also justify and support to proceed to a large confirmatory study to evaluate an effect of the intervention on BPD, in which the estimate of the impact on BPD gained in this pilot trial may be used to calculate a sample size.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Inhaled budesonide, Normal saline
- Keywords
- Budesonide, Inhalation, Premature infants
- Medical subject headings
- Bronchopulmonary Dysplasia, Respiratory Aspiration, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled budesonideDrug
Also called PULMICORT® NEBUAMP®
Inhaled budesonide 1 mg tid until 36 weeks' corrected gestational age or fully weaned from supplemental oxygen and respiratory support (CPAP or high flow nasal canula)
Normal salineDrug
Also called Placebo
2 ml normal saline by inhalation
| Study group | Role | What they receive |
|---|---|---|
| Inhaled budesonide | Experimental | Inhaled budesonide 1mg/dose (2ml) three tid Receives: Drug: Inhaled budesonide |
| Normal saline | Placebo comparator | Normal saline inhalation 2ml tid Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total days on supplemental oxygen from birth to discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary outcomes (13)
Bronchopulmonary dysplasia
Bronchopulmonary dysplasia is defined as supplemental oxygen use at 36+0/7 weeks corrected gestational age
Measured: At 36+0/7 weeks corrected gestational age
Mortality (all causes)
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Death or bronchopulmonary dysplasia
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days on supplement oxygen after the study enrollment
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days on continuous positive airway pressure (CPAP)
Support with continuous positive airway pressure, including use of biphasic CPAP and high flow nasal canula (>= 1L/minutes).
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days with significant apneas
Significant apneas with more than 12 episodes requiring stimulation or more than one episode requiring mask-bagging in a six hour period
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Culture proven sepsis
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Gastrointestinal bleeding
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Persistent hyperglycemia
blood glucose > 10mmol/L more than twice in one day
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hypertension
blood pressure ≥ 95th percentile for infant's gestational and postnatal ages
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Salivary cortisol level
Measured: 2 weeks after the study entry and at the first follow up visit at 6 week's corrected age
Postnatal growth
Weight, Head Circumference and Length
Measured: at 36 weeks corrected gestational age and at first follow-up visit at 6 weeks' corrected age
Patent ductus arteriosus
PDA diagnosed clinically or by echocardiography
Measured: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2013 (estimated)
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Dunn
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Michael Dunn, Sunnybrook Health Sciences Centre
- Investigators
- Michael Dunn, M.D., Principal investigator, Staff NeonatologistTetsuya Isayama, M.D., Principal investigator, Clinical Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895075
- Sponsor's protocol ID
- 001-2013
- Other IDs
- CTRL # 165648
- Status last verified
- Aug 2018
- First submitted
- 25 Jun 2013
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
- ClinicalTrials.gov ID
- NCT01895075
- Acronym / sponsor ID
- 001-2013
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Budesonide, Inhalation, Premature infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Insufficient funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Michael DunnUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 10 Jul 2013 (estimated)
- 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.
Bronchopulmonary dysplasia (BPD) is one of the most important morbidities of preterm infants with a high incidence and significant impact on resource utilization and long-term outcome. Systemic corticosteroids have been shown to be effective in the prevention of BPD through their potent anti-inflammatory effects but there are serious concerns on their potential detrimental effects on neurodevelopment of infants. In contrast, inhaled corticosteroids administered to ventilated infants are thought to be safer due to their topical effect but have not been shown to improve outcomes including BPD. To date, there have been few studies evaluating the effect of inhaled corticosteroids administered to non-ventilated infants for the prevention of BPD. Hence, we are conducting a double-blind randomized controlled pilot trial to examine the impact of inhaled budesonide on non-ventilated infants.
The study objectives, in a cohort of very preterm infants with signs of early BPD are: 1) to evaluate the effect of aerosolized budesonide on 'days on supplemental oxygen', and 2) to gain an estimate of the impact on BPD and 3) to assess the safety of the intervention in a small cohort of preterm infants.
This will be a single-center randomized double-blind controlled pilot trial. We will recruit a total of 50 infants born at less than 30 weeks gestation who are on continuous positive airway pressure (CPAP) with fraction of inspired oxygen ≥25% on day 14 of life or later. Inhaled budesonide 1mg (intervention group) or normal saline (placebo) will be administered three times a day until the infants do not need CPAP or supplemental oxygen or reach 36+0/7 weeks corrected gestational age. We will evaluate 'days on supplemental oxygen', BPD, re-intubation rates, days on mechanical ventilation and days on CPAP as well as adverse outcomes.
The prevention of BPD would have a significant positive impact on patient quality of life and medical resource utilization and costs. The study hypothesis is that inhaled budesonide on non-ventilated infants with early signs of BPD will reduce the 'days on supplemental oxygen' indicating a positive effect for the prevention of BPD. The result of this pilot study might also justify and support to proceed to a large confirmatory study to evaluate an effect of the intervention on BPD, in which the estimate of the impact on BPD gained in this pilot trial may be used to calculate a sample size.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled budesonide | Experimental | Drug: Inhaled budesonideInhaled budesonide 1mg/dose (2ml) three tid |
| Normal saline | Placebo comparator | Drug: Normal salineNormal saline inhalation 2ml tid |
Who may qualify
- Ages
- 14 to 42 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Spontaneous breathing preterm Infants on day 14 to day 42 of age
- Born at < 30 0/7 weeks gestational age
- Requiring FiO2 ≥ 25% on CPAP including biphasic CPAP or high flow nasal canula
Key exclusion criteria (3 listed)
- Presence of chromosomal defects or major congenital anomalies
- Presence of severe infections including sepsis, meningitis, pneumonia, systemic fungal infections
- History of administration of systemic corticosteroids for pulmonary problems, not including that for hypotension
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 |
|---|---|---|
| Inhaled budesonideAlso: PULMICORT® NEBUAMP®Inhaled budesonide 1 mg tid until 36 weeks' corrected gestational age or fully weaned from supplemental oxygen and respiratory support (CPAP or high flow nasal canula) | Drug | Inhaled budesonide |
| Normal salineAlso: Placebo2 ml normal saline by inhalation | Drug | Normal saline |
Primary outcome
Total days on supplemental oxygen from birth to discharge
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
13 secondary outcomes
Bronchopulmonary dysplasia
Time frame: At 36+0/7 weeks corrected gestational age
Mortality (all causes)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Death or bronchopulmonary dysplasia
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days on supplement oxygen after the study enrollment
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days on continuous positive airway pressure (CPAP)
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Days with significant apneas
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Culture proven sepsis
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Gastrointestinal bleeding
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Persistent hyperglycemia
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Hypertension
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Salivary cortisol level
Time frame: 2 weeks after the study entry and at the first follow up visit at 6 week's corrected age
Postnatal growth
Time frame: at 36 weeks corrected gestational age and at first follow-up visit at 6 weeks' corrected age
Patent ductus arteriosus
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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.
Michael Dunn, M.D. principal investigator
Staff Neonatologist
Tetsuya Isayama, M.D. principal investigator
Clinical Fellow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled budesonide and Normal saline in people with Bronchopulmonary Dysplasia, run by Dr. Michael Dunn at 1 site in Canada.
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 3 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Aug 2018. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total days on supplemental oxygen from birth to discharge (time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 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 13 Aug 2018.