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Completed

NCT Number: NCT03567473

Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

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.

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Key information

Conditions

Bronchiolitis Bronchial Diseases Bronchitis Infections Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

60 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Women and Children's Hospital, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

  • 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

  • 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.
  • 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.
  • 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.
  • Presenting with symptoms of apnea prior to enrollment.
  • Treatment with oral, inhaled, or IV corticosteroids within the last 1 week.
  • History of adverse reaction to glucocorticoids.
  • Treatment with any beta-agonists (salbutamol/albuterol or epinephrine/adrenaline) in the ED prior to study enrolment.
  • 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.
  • Insurmountable language barrier (patient's parent/guardian is unable to understand English or French to give informed consent and participate in follow-up).
  • 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.
  • Previous enrolment in the trial.
  • Unavailability for follow-up period.
  • Certain admission to hospital.

Treatment and study plan

Oral dexamethasone

Drug

Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later

Other names: Dexamethasone

Nebulized Epinephrine

Drug

Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

Other names: Nebulized Adrenaline

oral placebo

Drug

Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.

Other names: Placebo

Nebulized normal saline

Drug

Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment

Other names: Saline

MDI Epinephrine

Drug

Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.

Other names: MDI Adrenaline

MDI placebo

Drug

Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.

Other names: Placebo

Primary outcomes

  1. Admission to hospital for bronchiolitis within 7 days post enrollment

    Time frame: 7 days post enrollment

    • patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.

Secondary outcomes

  1. Admission to hospital for bronchiolitis at the time of the enrollment ED visit

    Time frame: Enrollment visit

    • patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.

  2. All cause admission to Hospital within 21 days following enrollment ED visit

    Time frame: up to 21 days post enrollment

    • patient being admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.

  3. All cause Health care provider visits (including ED visits) by day 21 following enrollment ED

    Time frame: up to 21 days post enrollment

    Visits to ED, other clinic, primary care provider, or any visit to see a nurse or physician following enrollment

  4. Health Care related costs within the 21 days following enrollment ED visits.

    Time frame: up to 21 days post enrollment

    Health care related costs

Other outcomes

  1. Safety outcome 1: Gastrointestinal bleeding

    Time frame: up to 21 days post enrollment

    involving melena or frank blood per rectum (and not attributable to other causes, as determined by the treating physician)

  2. Safety outcome 2: Serious Bacterial Infection

    Time frame: up to 21 days post enrollment

    meningitis, osteomyelitis or septicaemia

  3. Safety outcome 3: Severe Varicella

    Time frame: up to 21 days post enrollment

    All of the following including: arthritis, osteomyelitis, symptomatic hepatitis, pancreatitis, cerebritis, pneumonitis, glomerulonephritis, disseminated intravascular coagulation, thrombo-cytopenia, prolonged vesicular rash (<3 weeks), fasciitis, septicaemia, ocular complications, orchitis, myocarditis, intensive care admission and death

  4. Safety outcome 4: Death

    Time frame: up to 21 days post enrollment

    Death

  5. Exploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visit

    Time frame: up to 21 days post enrollment

    • Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.

  6. Exploratory Outcome 2: Admission to ICU within 21 days following enrollment ED visit for bronchiolitis and requiring intubation or continuous positive airway pressure (CPAP)

    Time frame: up to 21 days post enrollment

    Physician admitting patient to ICU for bronchiolitis and requiring oxygen or ventilatory support

  7. Exploratory Outcome 3: All cause admission to hospital with 7 days following enrollment ED visit

    Time frame: up to 7 days post enrollment ED visit

    • Patient admitted to inpatient ward, or 2) an ED length of stay 12 hours or greater or 3) a combined ED and observation unit stay of 12 hours or greater.

  8. Exploratory Outcome 4: All cause ED visits within 21 days following enrollment ED visit

    Time frame: up to 21 days post enrollment ED

    Visits to the ED after initial enrollment ED visit

  9. Exploratory Outcome 5: Length of stay for the enrollment ED visit (in hours)

    Time frame: Enrollment ED visit

    defined as discharge time minus oral study medication time, for participants discharged at the enrollment ED

  10. Exploratory Outcome 6: Length of hospital admission for those patients admitted at their enrollment visit

    Time frame: Admissions at enrollment ED visit

    time of hospital discharge minus the time of oral study medication

  11. Exploratory Outcome 7: Resolution of symptoms as documented on a standardized questionnaire during the telephone or email at day 7 and 21 days.

    Time frame: up to 21 days post enrollment

    cough, noisy breathing, respiratory distress, sleep and ability to feed

  12. Exploratory Outcome 8: Out of pocket expenses

    Time frame: up to 21 days post enrollment

    transportation, days of missed work, missed leisure activities

  13. Exploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illness

    Time frame: Up to 18 years of age

    future health care utilization

  14. Exploratory Outcome 11: Development of respiratory illnesses

    Time frame: Up to 18 years of age

    asthma, wheezing and other respiratory illnesses

Sponsors and collaborators

Lead sponsor

Children's Hospital of Eastern Ontario

Other

Collaborators

  • Alberta Children's Hospital Research Institute
  • Canadian Institutes of Health Research (CIHR)
  • Children's Hospital Research Institute of Manitoba
  • Department of Pediatrics, Western University
  • Research Manitoba
  • St. Justine's Hospital
  • The Hospital for Sick Children
  • Women and Children's Health Research Institute, Canada

Registry information

Official study title

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

Acronym: BIPED

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2018
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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