Comparing epinephrine and dexamethasone to placebo for treating bronchiolitis in infants

A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis

This study is testing if giving infants with bronchiolitis a mix of inhaled epinephrine and oral dexamethasone can help keep them out of the hospital compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 864 (estimated)
• Ages: 60 Days to 12 Months
• Sex: All
• Sponsor: Children's Hospital of Eastern Ontario (Academic / other)
• Locations: 12 sites (Adelaide and 11 other locations)
• Trial ID: NCT03567473 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of inhaled epinephrine combined with a short course of oral dexamethasone in reducing hospitalizations for infants diagnosed with bronchiolitis. Conducted in multiple emergency departments, infants will be randomly assigned to receive either the active treatment or a placebo. The primary outcome will be the rate of hospital admissions for bronchiolitis within seven days of enrollment. The study aims to provide evidence on whether this combination therapy can improve outcomes for infants during peak respiratory virus seasons.

Who should consider this trial

Good fit: Ideal candidates are infants aged 60 days to less than 12 months presenting with bronchiolitis symptoms during peak RSV seasons.

Not a fit: Patients with bronchiolitis who are older than 12 months or younger than 60 days will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce hospitalizations for infants suffering from bronchiolitis.

How similar studies have performed: Previous studies have shown promising results with similar treatments for bronchiolitis, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Presenting to the ED with an episode of bronchiolitis. Bronchiolitis will be defined as an episode of wheezing or crackles in a child \< 12 month of age associated with signs of an upper respiratory tract infection (e.g. cough, coryza, nasal congestion) during the period deemed to be peak season for RSV bronchiolitis (approximately December to April in Northern Hemisphere and June to October in Southern Hemisphere). We have chosen not to define bronchiolitis as the first episode of wheezing or crackles to better reflect the clinical guidelines and clinical practice internationally.

   \*Adjustment for COVID-19: The COVID-19 pandemic has resulted in unseasonal RSV and bronchiolitis seasons. As such, adjustments will be made to study recruitment to ensure recruitment occurs during peak RSV times. In order to achieve this aim, the study may in some sites recruit for 12 months of the year.
2. Age 60 days to less than 12 months. Children younger than 60 days will not be enrolled due to the risk of concomitant infection and other issues pertaining to glucocorticoid use in the very young. Children older than 12 months will not be enrolled to minimize the risk of enrolling children with asthma.

Exclusion Criteria:

1. Respiratory distress assessment instrument (RDAI) score of less than or equal to 3. This RDAI will ensure children with very mild respiratory diseases are not enrolled. This is the lower limit of the RDAI range used in CanBEST.
2. Previously known chronic disease that may affect cardiopulmonary status of the patient, such as bronchopulmonary dysplasia currently receiving oxygen, cystic fibrosis, congenital heart disease and immune deficiency. These children may be at higher risk for developing severe illness.
3. Severe respiratory distress evidenced by a sustained pulse rate \> 200 beats/min, a sustained respiratory rate \> 80 breaths/min, profound lethargy (as deemed by the treating physician), or requiring resuscitation room care. We will exclude these children as they are likely to be admitted due to severity of illness.
4. Presenting with symptoms of apnea prior to enrollment.
5. Treatment with oral, inhaled, or IV corticosteroids within the last 1 week.
6. History of adverse reaction to glucocorticoids.
7. Treatment with any beta-agonists (salbutamol/albuterol or epinephrine/adrenaline) in the ED prior to study enrolment.
8. Presence of varicella or recent (less than 3 weeks) close contact (defined as any household or daycare contact, or greater than 15 minutes of face to face contact, or greater than 1 hour of being in the same dwelling with an individual) without a history of prior infection. These patients are not enrolled to reduce any risk of developing severe varicella with corticosteroid use.
9. Insurmountable language barrier (patient's parent/guardian is unable to understand English or French to give informed consent and participate in follow-up).
10. Any child born at less than 37weeks gestation who is younger than 60 days corrected age. We will not enroll these children to lower any risk of exposing young infants to corticosteroids.
11. Previous enrolment in the trial.
12. Unavailability for follow-up period.
13. Certain admission to hospital.

Where this trial is running

Adelaide and 11 other locations

• Women and Children's Hospital — Adelaide, Australia (Recruiting)
• Monash Medical Centre — Melbourne, Australia (Recruiting)
• Perth Children's Hospital — Perth, Australia (Recruiting)
• Children's Hospital of Alberta — Calgary, Alberta, Canada (Recruiting)
• Stollery Children's Hospital — Edmonton, Alberta, Canada (Recruiting)
• Childrens Hospital at London Health Sciences — London, Ontario, Canada (Recruiting)
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada (Recruiting)
• CHU Sainte-Justines Hospital — Montréal, Quebec, Canada (Recruiting)
• Children's Hospital of Winnipeg — Sherbrook, Winnipeg, Canada (Recruiting)
• Starship Children's Hospital — Auckland, New Zealand (Recruiting)
• Kidz First Hospital — Auckland, New Zealand (Recruiting)
• Waikato Hospital — Hamilton, New Zealand (Recruiting)

Study contacts

• Principal investigator: Amy Plint, MSc, MD — Childrens Hospital of Eastern Ontario (CHEO)
• Study coordinator: Natasha Wills-Ibarra

Conditions Bronchiolitis