Bronchopulmonary Dysplasia Clinical Trial
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.
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.
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