Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

Last updated: February 28, 2025
Sponsor: Children's Hospital of Eastern Ontario
Overall Status: Active - Recruiting

Phase

3

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

Oral placebo

Oral dexamethasone

Nebulized Epinephrine

Clinical Study ID

NCT03567473
CTO 1423
  • Ages 60-12
  • All Genders

Study Summary

We hypothesize that infants with bronchiolitis treated with inhaled epinephrine in the Emergency Department (ED) and a 2-day course of oral dexamethasone will have fewer hospitalizations over 7 days compared to infants treated with placebo. To examine this hypothesis, we will conduct a phase III, multicentre, randomized, double-blind trial. Infants presenting to one of twelve study EDs will be enrolled to one of two study groups: (1) inhaled epinephrine and oral dexamethasone or (2) inhaled placebo and oral placebo. Our primary outcome will be admission for bronchiolitis by day 7 following the enrolment. As a planned secondary analysis, a between-group comparison of the primary outcome will be performed in those patients presenting with a first episode of bronchiolitis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

*Adjustment for COVID-19: The COVID-19 pandemic has resulted in unseasonal RSV andbronchiolitis seasons. As such, adjustments will be made to study recruitment toensure recruitment occurs during peak RSV times. In order to achieve this aim, thestudy may in some sites recruit for 12 months of the year.

  1. Age 60 days to less than 12 months. Children younger than 60 days will not beenrolled due to the risk of concomitant infection and other issues pertaining toglucocorticoid use in the very young. Children older than 12 months will not beenrolled to minimize the risk of enrolling children with asthma.

Exclusion

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 thepatient, such as bronchopulmonary dysplasia currently receiving oxygen, cysticfibrosis, congenital heart disease and immune deficiency. These children may be athigher risk for developing severe illness.

  3. Severe respiratory distress evidenced by a sustained pulse rate > 200 beats/min, asustained respiratory rate > 80 breaths/min, profound lethargy (as deemed by thetreating physician), or requiring resuscitation room care. We will exclude thesechildren 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) inthe ED prior to study enrolment.

  8. Presence of varicella or recent (less than 3 weeks) close contact (defined as anyhousehold or daycare contact, or greater than 15 minutes of face to face contact, orgreater than 1 hour of being in the same dwelling with an individual) without ahistory of prior infection. These patients are not enrolled to reduce any risk ofdeveloping severe varicella with corticosteroid use.

  9. Insurmountable language barrier (patient's parent/guardian is unable to understandEnglish 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 correctedage. We will not enroll these children to lower any risk of exposing young infantsto corticosteroids.

  11. Previous enrolment in the trial.

  12. Unavailability for follow-up period.

  13. Certain admission to hospital.

Study Design

Total Participants: 864
Treatment Group(s): 6
Primary Treatment: Oral placebo
Phase: 3
Study Start date:
December 13, 2018
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Women and Children's Hospital

    Adelaide, 5006
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Melbourne, 3168
    Australia

    Active - Recruiting

  • Perth Children's Hospital

    Perth, 6008
    Australia

    Active - Recruiting

  • Children's Hospital of Alberta

    Calgary, Alberta T3B 6A9
    Canada

    Active - Recruiting

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2C8
    Canada

    Active - Recruiting

  • Childrens Hospital at London Health Sciences

    London, Ontario N6A 5W9
    Canada

    Active - Recruiting

  • CHEO

    Ottawa, Ontario K1H 8L1
    Canada

    Active - Recruiting

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Active - Recruiting

  • CHU Sainte-Justines Hospital

    Montréal, Quebec HT3 1C5
    Canada

    Active - Recruiting

  • Children's Hospital of Winnipeg

    Sherbrook, Winnipeg R3A 1S1
    Canada

    Active - Recruiting

  • Kidz First Hospital

    Auckland, 2025
    New Zealand

    Active - Recruiting

  • Starship Children's Hospital

    Auckland, 1142
    New Zealand

    Active - Recruiting

  • Waikato Hospital

    Hamilton, 3240
    New Zealand

    Active - Recruiting

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