Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Bronchitis (Pediatric)
Treatment
Oral placebo
Oral dexamethasone
Nebulized Epinephrine
Clinical Study ID
Ages 60-12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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.
- 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:
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 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.
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.
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) inthe ED prior to study enrolment.
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.
Insurmountable language barrier (patient's parent/guardian is unable to understandEnglish 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 correctedage. We will not enroll these children to lower any risk of exposing young infantsto corticosteroids.
Previous enrolment in the trial.
Unavailability for follow-up period.
Certain admission to hospital.
Study Design
Connect with a study center
Women and Children's Hospital
Adelaide, 5006
AustraliaActive - Recruiting
Monash Medical Centre
Melbourne, 3168
AustraliaActive - Recruiting
Perth Children's Hospital
Perth, 6008
AustraliaActive - Recruiting
Children's Hospital of Alberta
Calgary, Alberta T3B 6A9
CanadaActive - Recruiting
Stollery Children's Hospital
Edmonton, Alberta T6G 2C8
CanadaActive - Recruiting
Childrens Hospital at London Health Sciences
London, Ontario N6A 5W9
CanadaActive - Recruiting
CHEO
Ottawa, Ontario K1H 8L1
CanadaActive - Recruiting
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8L1
CanadaActive - Recruiting
CHU Sainte-Justines Hospital
Montréal, Quebec HT3 1C5
CanadaActive - Recruiting
Children's Hospital of Winnipeg
Sherbrook, Winnipeg R3A 1S1
CanadaActive - Recruiting
Kidz First Hospital
Auckland, 2025
New ZealandActive - Recruiting
Starship Children's Hospital
Auckland, 1142
New ZealandActive - Recruiting
Waikato Hospital
Hamilton, 3240
New ZealandActive - Recruiting
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