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

NCT ID: NCT01895075

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-09-01

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.

Conditions

Bronchopulmonary Dysplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Inhaled budesonide

Inhaled budesonide 1mg/dose (2ml) three tid

Group Type: EXPERIMENTAL

Inhaled budesonide

Intervention Type: DRUG

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 saline

Normal saline inhalation 2ml tid

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

2 ml normal saline by inhalation

Interventions

Inhaled budesonide

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)

Intervention Type: DRUG

Normal saline

2 ml normal saline by inhalation

Intervention Type: DRUG

Other Intervention Names

PULMICORT® NEBUAMP®; Placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 42 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Michael Dunn

OTHER

Sponsor Role: lead

Responsible Party

Dr. Michael Dunn

Staff neonatologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Michael Dunn, M.D.

Role: PRINCIPAL_INVESTIGATOR

Staff Neonatologist

Tetsuya Isayama, M.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Fellow

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

CTRL # 165648

Identifier Type: OTHER

Identifier Source: secondary_id

001-2013

Identifier Type: -

Identifier Source: org_study_id