Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study
- Conditions
- Bronchopulmonary Dysplasia
- Interventions
- Drug: Normal saline
- Registration Number
- NCT01895075
- Lead Sponsor
- Dr. Michael Dunn
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal saline Normal saline Normal saline inhalation 2ml tid Inhaled budesonide Inhaled budesonide Inhaled budesonide 1mg/dose (2ml) three tid
- Primary Outcome Measures
Name Time Method Total days on supplemental oxygen from birth to discharge Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
- Secondary Outcome Measures
Name Time Method Patent ductus arteriosus Participants will be followed for the duration of hospital stay, an expected average of 8 weeks PDA diagnosed clinically or by echocardiography
Culture proven sepsis Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Salivary cortisol level 2 weeks after the study entry and at the first follow up visit at 6 week's corrected age Death or bronchopulmonary dysplasia Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Days on supplement oxygen after the study enrollment Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Days on continuous positive airway pressure (CPAP) Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Support with continuous positive airway pressure, including use of biphasic CPAP and high flow nasal canula (\>= 1L/minutes).
Bronchopulmonary dysplasia At 36+0/7 weeks corrected gestational age Bronchopulmonary dysplasia is defined as supplemental oxygen use at 36+0/7 weeks corrected gestational age
Mortality (all causes) Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Days with significant apneas Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Significant apneas with more than 12 episodes requiring stimulation or more than one episode requiring mask-bagging in a six hour period
Gastrointestinal bleeding Participants will be followed for the duration of hospital stay, an expected average of 8 weeks Postnatal growth at 36 weeks corrected gestational age and at first follow-up visit at 6 weeks' corrected age Weight, Head Circumference and Length
Persistent hyperglycemia Participants will be followed for the duration of hospital stay, an expected average of 8 weeks blood glucose \> 10mmol/L more than twice in one day
Hypertension Participants will be followed for the duration of hospital stay, an expected average of 8 weeks blood pressure ≥ 95th percentile for infant's gestational and postnatal ages
Trial Locations
- Locations (1)
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada