Trial · NCT07901400
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean total number of hospitalization days through day 14 | Up to day 14 | For each infant, the cumulative number of days spent in conventional hospitalization will include hospitalization immediately following the index pediatric emergency department visit and any subsequent hospitalization or rehospitalization through Day 14 for worsening bronchiolitis or a complication related to management of the index episode. Hospital records and discharge reports will be checked against information obtained during the Day 14 parent telephone call. The mean number of days will be estimated for each study group and compared using a mixed-effects regression model accounting for clustering by center. |
| Secondary | Percentage of infants conventionally hospitalized immediately after the emergency department visit | Day 0 | Percentage of enrolled infants admitted to conventional inpatient care immediately after the pediatric emergency department visit that led to inclusion. The percentage will be compared between study groups using a mixed-effects logistic regression model. |
| Secondary | Percentage of infants transferred to another hospital for immediate hospitalization | Day 0 | Percentage of enrolled infants transferred to another hospital for immediate hospitalization following the index pediatric emergency department visit. The percentage will be compared between study groups using a mixed-effects logistic regression model. |
| Secondary | Parent Satisfaction Index Score Day0 | Day 0 | Parent satisfaction with the infant's care will be assessed using the study-specific standardized questionnaire. It covers information about bronchiolitis and its management, involvement in care, comfort and perceived safety during care, and perceived quality of care. Scores will be summarized by study group. |
| Secondary | Parent Satisfaction Index Score Day14 | Day 14 | Parent satisfaction with the infant's care will be assessed using the study-specific standardized questionnaire. It covers information about bronchiolitis and its management, involvement in care, comfort and perceived safety during care, and perceived quality of care. |
| Secondary | Parent Experience PPE-15 | Day14 | Parent experience assessed by telephone with the 15-item Picker Patient Experience Questionnaire (PPE-15) adapted for pedriatric care. |
| Secondary | Percentage of parents able to recall advice at Day 14 | Day 14 | Percentage of parents who recall the advice provided, assessed by telephone using the study-specific questionnaire. The percentage will be compared between study groups using a mixed-effects logistic regression model. |
| Secondary | Healthcare professional satisfaction score | 2 years, 3 years and 4 years (at the end of each center's first bronchiolitis epidemic season following implementation of the intervention) | Medical and paramedical staff ratings of perceived quality of service to families, department crowding, and team cohesion. Each item is rated on a four-point Likert scale; individual items and their mean will be reported. |
| Secondary | Percentage of infants with at least one adverse event | Up to Day 14 | Percentage of infants experiencing at least one adverse event during the 14 days following inclusion. Events will also be described by nature, severity, and cause category, including disease progression and care organization, after event validation committee review. |
| Secondary | Percentage of infants with at least one adverse serious adverse event | Up to Day 14 | Percentage of infants experiencing at least one serious adverse event during the 14 days following inclusion. Events will also be described by nature, severity, and cause category, including disease progression and care organization, after event validation committee review. |
| Secondary | Mean cost of infant care | Up to Day 14 | Mean healthcare cost per participant from the healthcare-system perspective, including emergency care, hospitalization, rehospitalization, personnel, and consumables. The intervention pathway will be evaluated using mixed bottom-up and top-down micro-costing methods. |
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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