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

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01895075
• Other study ID #: 001-2013
• Secondary ID: CTRL # 165648
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2018
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 42 Days

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Drug:
• 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)
• Normal saline
2 ml normal saline by inhalation

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Michael Dunn

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intraventricular hemorrhage	Any grade of intraventricular hemorrhage as assessed on cranial ultrasound	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Other	Periventricular leukomalacia	Cystic periventricular leukomalacia as assessed by cranial ultrasound	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Other	Retinopathy of prematurity	Stage 3 or 4 or surgery as determined from ophthalmological examination	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Other	Necrotizing enterocolitis	Bell's stage 2 or higher	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Primary	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	Bronchopulmonary dysplasia	Bronchopulmonary dysplasia is defined as supplemental oxygen use at 36+0/7 weeks corrected gestational age	At 36+0/7 weeks corrected gestational age
Secondary	Mortality (all causes)		Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Death or bronchopulmonary dysplasia		Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Days on supplement oxygen after the study enrollment		Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	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).	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	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	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Culture proven sepsis		Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Gastrointestinal bleeding		Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Persistent hyperglycemia	blood glucose > 10mmol/L more than twice in one day	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Hypertension	blood pressure = 95th percentile for infant's gestational and postnatal ages	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks
Secondary	Salivary cortisol level		2 weeks after the study entry and at the first follow up visit at 6 week's corrected age
Secondary	Postnatal growth	Weight, Head Circumference and Length	at 36 weeks corrected gestational age and at first follow-up visit at 6 weeks' corrected age
Secondary	Patent ductus arteriosus	PDA diagnosed clinically or by echocardiography	Participants will be followed for the duration of hospital stay, an expected average of 8 weeks