NCT01895075

Inhaled Budesonide for Non-ventilated Infants at High Risk of Bronchopulmonary Dysplasia: the i-BUD Pilot Study

Withdrawn Phase 2 Last updated 13 August 2018

What this trial tests

Phase 2 trial testing Inhaled budesonide in Bronchopulmonary Dysplasia. Withdrawn.

Timeline

1 January 2019

Primary endpoint
1 July 2020

1 September 2020

Quick facts

Lead sponsor	Dr. Michael Dunn
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 January 2019
Primary completion	1 July 2020
Estimated completion	1 September 2020
Sites	1 location across Canada

Drugs / interventions tested

• Inhaled budesonide — full drug profile →
• Normal saline

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Dr. Michael Dunn

Who can join

Adults 14 Days to 42 Days, any sex, with Bronchopulmonary Dysplasia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Late (≥ 7 days) inhaled corticosteroids to reduce bronchopulmonary dysplasia in preterm infants.
   Onland W, Offringa M, van Kaam A. · · 2022 · cited 7× · PMID 36521169 · DOI 10.1002/14651858.cd002311.pub5
2. Drug versus placebo randomized controlled trials in neonates: A review of ClinicalTrials.gov registry.
   Desselas E, Pansieri C, Leroux S, Bonati M, et al · · 2017 · cited 4× · PMID 28192509 · DOI 10.1371/journal.pone.0171760