Bronchiolitis in Infants Placebo Versus Epinephrine and Dexamethasone Study

Launched by CHILDREN'S HOSPITAL OF EASTERN ONTARIO · Jun 13, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of treating infants with bronchiolitis using two medications: inhaled epinephrine and oral dexamethasone. The goal is to see if this combination treatment can reduce the number of infants who need to be hospitalized for bronchiolitis compared to a placebo, which is a treatment without any active medication. The trial will include infants between 60 days and 12 months old who show signs of bronchiolitis, such as wheezing or coughing, and are visiting one of the participating emergency departments during peak times for respiratory infections.

If your child qualifies for the trial, they will be randomly assigned to receive either the medication or a placebo, and their health will be monitored for a week to see if they need to be hospitalized. It’s important to note that not all infants will be eligible. For example, those with serious breathing problems or certain pre-existing health conditions won't be included. The study aims to better understand how these treatments work, which could help improve care for infants with bronchiolitis in the future.

Gender

ALL

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.