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Trial · NCT03567473

Registered outcomes19

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAdmission to hospital for bronchiolitis within 7 days post enrollment7 days post enrollment1\) 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.
SecondaryAdmission to hospital for bronchiolitis at the time of the enrollment ED visitEnrollment visit1\) 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.
SecondaryAll cause admission to Hospital within 21 days following enrollment ED visitup to 21 days post enrollment1\) 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.
SecondaryAll cause Health care provider visits (including ED visits) by day 21 following enrollment EDup to 21 days post enrollmentVisits to ED, other clinic, primary care provider, or any visit to see a nurse or physician following enrollment
SecondaryHealth Care related costs within the 21 days following enrollment ED visits.up to 21 days post enrollmentHealth care related costs
OtherSafety outcome 1: Gastrointestinal bleedingup to 21 days post enrollmentinvolving melena or frank blood per rectum (and not attributable to other causes, as determined by the treating physician)
OtherSafety outcome 2: Serious Bacterial Infectionup to 21 days post enrollmentmeningitis, osteomyelitis or septicaemia
OtherSafety outcome 3: Severe Varicellaup 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
OtherSafety outcome 4: Deathup to 21 days post enrollmentDeath
OtherExploratory Outcome 1: Admission to hospital for bronchiolitis within 21 days following enrollment ED visitup to 21 days post enrollment1\) 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.
OtherExploratory Outcome 2: Admission to ICU within 21 days following enrollment ED visit for bronchiolitis and requiring intubation or continuous positive airway pressure (CPAP)up to 21 days post enrollmentPhysician admitting patient to ICU for bronchiolitis and requiring oxygen or ventilatory support
OtherExploratory Outcome 3: All cause admission to hospital with 7 days following enrollment ED visitup to 7 days post enrollment ED visit1\) 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.
OtherExploratory Outcome 4: All cause ED visits within 21 days following enrollment ED visitup to 21 days post enrollment EDVisits to the ED after initial enrollment ED visit
OtherExploratory Outcome 5: Length of stay for the enrollment ED visit (in hours)Enrollment ED visitdefined as discharge time minus oral study medication time, for participants discharged at the enrollment ED
OtherExploratory Outcome 6: Length of hospital admission for those patients admitted at their enrollment visitAdmissions at enrollment ED visittime of hospital discharge minus the time of oral study medication
OtherExploratory Outcome 7: Resolution of symptoms as documented on a standardized questionnaire during the telephone or email at day 7 and 21 days.up to 21 days post enrollmentcough, noisy breathing, respiratory distress, sleep and ability to feed
OtherExploratory Outcome 8: Out of pocket expensesup to 21 days post enrollmenttransportation, days of missed work, missed leisure activities
OtherExploratory Outcome 10: Health care utilization (including ambulatory visits, ED visits, hospitalization) for respiratory illnessUp to 18 years of agefuture health care utilization
OtherExploratory Outcome 11: Development of respiratory illnessesUp to 18 years of ageasthma, wheezing and other respiratory illnesses

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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