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Trial registered on ANZCTR
Registration number
ACTRN12626000791336
Ethics application status
Approved
Date submitted
6/06/2026
Date registered
1/07/2026
Date last updated
1/07/2026
Date data sharing statement initially provided
1/07/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
Virtual Emergency Department Short-Stay Unit for infants with mild bronchiolitis: a non-inferiority randomised controlled trial of hospital-level care at home using remote patient monitoring to assess oxygen therapy, acceptability and cost outcomes
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Scientific title
Virtual Emergency Department Short-Stay Unit for infants with mild bronchiolitis: a non-inferiority randomised controlled trial of hospital-level care at home using remote patient monitoring to assess oxygen therapy, acceptability and cost outcomes
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Additional trial identifiers [1]
317510
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Related trial records
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Health condition
Health condition(s) studied:
Bronchiolitis
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Condition category
Condition code
Respiratory
338363
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0
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Other respiratory disorders / diseases
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Public Health
338629
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
The intervention is a virtual Emergency Department Short-Stay Unit (EDSSU) admission, delivered as an alternative to physical EDSSU admission for infants with mild bronchiolitis who have been assessed in the Emergency Department as requiring short-stay observation. The intervention provides hospital-level observation and clinical support at home through wearable remote patient monitoring, scheduled audiovisual nursing reviews, daily paediatrician-led virtual ward rounds, 24/7 access to clinical support, and clear escalation pathways back to hospital if required.
Care is delivered by the virtualKIDS nursing and medical team, with oversight from paediatricians experienced in paediatric acute care and virtual models of care. The intervention is delivered individually to each participant in their home using audiovisual telehealth, telephone support when required, and continuous wearable remote monitoring.
Each infant allocated to the virtual EDSSU arm will be fitted with the Masimo SafetyNet™/Radius PPG™ remote patient monitoring system. The Masimo Radius PPG™ sensor/probe is applied to an appropriate peripheral site according to manufacturer instructions and local clinical training. The device connects to the Masimo SafetyNet™ application and supports remote monitoring of oxygen saturation, heart rate and respiratory rate by the virtualKIDS team. Families are provided with education on device use, probe positioning, troubleshooting, expected observations, and when to contact the virtualKIDS team. A backup Masimo Radius PPG™ probe is provided in case the primary probe fails, dislodges or cannot provide reliable readings.
The monitoring system is used continuously for the duration of the virtual EDSSU admission, with alerts and prompts available to parents/carers and clinicians in the virtualKIDS Command Hub. Continuous monitoring is complemented by scheduled 4-hourly reviews, including a full audiovisual assessment by a trained virtualKIDS nurse. These reviews include assessment of heart rate, respiratory rate, oxygen saturation, work of breathing and hydration, aligned with usual paediatric observation and escalation processes. Infants also receive a daily paediatrician-led virtual ward round.
The intervention begins after consent, randomisation and allocation to the virtual EDSSU arm, once the infant has been assessed in the Emergency Department as requiring EDSSU-level observation. Monitoring commences when the infant is discharged home under the virtual EDSSU model and continues until the infant is clinically ready for discharge or requires escalation to hospital-based care. A final face-to-face Acute Review Clinic appointment is used for discharge assessment and device removal, unless the infant is escalated earlier for hospital assessment.
Parents/carers have 24/7 access to the virtualKIDS clinical support line and may self-escalate at any time if they are concerned. Adherence and safety are supported through parent/carer education, continuous remote monitoring, scheduled 4-hourly clinical reviews, device alerts, backup equipment, a 24/7 support line and predefined escalation criteria. If the device, application, probe, internet connection or audiovisual connection cannot be restored, or if the infant cannot be safely monitored for more than four hours, this is treated as a technology failure and the infant is directed to return for hospital assessment.
Remote patient monitoring is used as an enabling technology; the study is evaluating the virtual EDSSU model of care, rather than the device alone. The study will assess whether the virtual EDSSU model is non-inferior to physical EDSSU admission. The primary outcome is the proportion of participants requiring oxygen therapy within 7 days of randomisation. Secondary outcomes include length of stay, ED re-presentation, admission or transfer to physical care, adverse events, technology failure, parent/carer confidence and preparedness, acceptability to families and clinicians, and health-system and family costs.
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Intervention code [1]
334302
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Treatment: Other
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Description of the comparator or control
The comparator is standard care through physical admission to the Emergency Department Short-Stay Unit (EDSSU).
Infants randomised to the control arm will remain in hospital and receive usual EDSSU care for mild bronchiolitis. Care is delivered face to face by the EDSSU nursing and medical team, including bedside nursing observations and medical review as clinically required. Observations include heart rate, respiratory rate, work of breathing, oxygen saturation and hydration status.
Participants in the physical EDSSU arm will receive 4-hourly clinical observations and daily paediatrician review, consistent with usual EDSSU care. Parents and carers can escalate concerns directly to the bedside nursing or medical team while the infant remains in hospital.
The comparator is delivered in the hospital EDSSU setting at the participating study sites. Participants remain in the physical EDSSU until they are clinically ready for discharge, according to standard hospital discharge criteria. Discharge occurs after in-person clinical review. Clinical outcomes, safety events, length of stay, re-presentation, parent/carer experience and cost-related data will be collected for comparison with the virtual EDSSU intervention arm.
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Control group
Active
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Outcomes
Primary outcome [1]
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Need for oxygen therapy
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Assessment method [1]
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This will be assessed by review of the participant’s medical record to determine whether supplemental oxygen was applied at any time during the 7-day follow-up period after randomisation.
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Timepoint [1]
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Within 7 days of randomisation
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Secondary outcome [1]
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Length of stay
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Assessment method [1]
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Length of stay will be determined by review of the participant’s medical record, including emergency department, short-stay unit, virtual care and inpatient admission records where applicable.
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Timepoint [1]
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From randomisation to discharge from the allocated model of care
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Secondary outcome [2]
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Emergency department re-presentation
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Assessment method [2]
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Emergency department re-presentation related to bronchiolitis will be determined by review of the participant’s medical record.
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Timepoint [2]
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Within 7 days of randomisation
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Secondary outcome [3]
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This will be assessed as a composite outcome. The composite outcome includes transfer from virtual EDSSU care to physical emergency department or short-stay hospital care, admission to a physical Emergency Department Short-Stay Unit, or inpatient ward admission. This will be determined by review of the participant’s medical record, virtualKIDS clinical records and hospital admission records.
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Assessment method [3]
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Hospital admission, transfer from virtual care to physical short-stay care, or inpatient ward admission will be determined by review of the participant’s medical record.
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Timepoint [3]
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Within 7 days of randomisation
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Secondary outcome [4]
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Unplanned virtual clinical reviews
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Assessment method [4]
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The number of unplanned virtual reviews will be determined from virtualKIDS clinical records and participant monitoring records.
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Timepoint [4]
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During the virtual emergency department short-stay unit admission
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Secondary outcome [5]
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Adverse events
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Assessment method [5]
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Adverse events, including escalation to high-acuity care, will be determined by review of the participant’s medical record, study safety records and adverse event reporting records.
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Timepoint [5]
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Within 7 days of randomisation
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Secondary outcome [6]
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Technology failure
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Assessment method [6]
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Technology failure will be assessed from study records, virtualKIDS records and participant monitoring records. Technology failure is defined as failure of the monitoring device, application, probe, internet connection or connectivity for more than four hours such that the participant cannot be safely monitored.
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Timepoint [6]
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During the virtual emergency department short-stay unit admission
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Secondary outcome [7]
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Parent or carer confidence and preparedness
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Assessment method [7]
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Parent or carer confidence and preparedness to manage their child’s care will be assessed using study-specific parent or carer survey questions.
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Timepoint [7]
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At baseline/allocation and 48 hours to 7 days after discharge or transfer
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Secondary outcome [8]
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Parent or carer anxiety
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Assessment method [8]
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Parent or carer anxiety will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale.
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Timepoint [8]
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At baseline/allocation and 48 hours to 7 days after discharge or transfer
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Secondary outcome [9]
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Parent or carer experience and acceptability
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Assessment method [9]
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Parent or carer experience and acceptability will be assessed using a study-specific qualitative survey or interview exploring perceived safety, confidence, use of technology, access to clinical support, impact on family routines and satisfaction with care.
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Timepoint [9]
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48 hours to 7 days after discharge or transfer
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Secondary outcome [10]
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Clinician experience and acceptability
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Assessment method [10]
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Clinician experience and acceptability will be assessed using a study-specific qualitative survey or interview exploring perceived safety, feasibility, workflow impact, escalation processes, technology usability, barriers and enablers to implementation, and sustainability.
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Timepoint [10]
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Any time from commencement of the trial
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Secondary outcome [11]
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Health-system cost of care
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Assessment method [11]
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Health-system costs will be assessed using electronic medical records, hospital administrative datasets, emergency department and admitted patient datasets, and virtualKIDS cost-centre data.
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Timepoint [11]
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From randomisation to 7 days after randomisation
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Secondary outcome [12]
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Family and societal cost of care
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Assessment method [12]
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The parent/carer survey questions assessing confidence, preparedness, experience, acceptability, and family and societal costs have been designed specifically for this study and are not from a previously validated survey. These study-specific questions will assess the parent/carer’s experience of the infant’s bronchiolitis admission and the allocated model of care, including travel, parking, meals, accommodation where relevant, childcare or care of other dependants, time away from paid or unpaid work, time away from usual activities, and time to return to work or usual activities. Parent/carer anxiety will be assessed before and after the admission/enrolment period to explore anxiety related to the infant’s bronchiolitis illness, the need for short-stay observation, and the allocated model of care. This will be assessed using the anxiety subscale of the Hospital Anxiety and Depression Scale. This is not intended to assess general anxiety as a diagnosis, but rather to provide a contextual measure of parent/carer anxiety during the acute illness and care episode.
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Timepoint [12]
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48 hours to 7 days after discharge or transfer
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Eligibility
Key inclusion criteria
1. Infant aged 3 months to less than 12 months, corrected age.
2. Presenting to the Emergency Department with mild bronchiolitis, as defined by the PREDICT bronchiolitis guideline.
3. Assessed by the treating Emergency Department doctor as requiring Emergency 4. Department Short-Stay Unit admission for observation.
5. Parent or legal guardian is able to provide written informed consent.
6. Parent or legal guardian is willing for the infant to be randomised to either physical
7. Emergency Department Short-Stay Unit care or virtual Emergency Department Short-Stay Unit care at home.
8. For infants allocated to the virtual care arm, the family must have reliable internet connectivity through wireless or cellular network, and be able to return to hospital for in-person review or escalation if required.
9. For infants allocated to the virtual care arm, the family must be able to attend a final in-person Acute Review Clinic appointment for discharge assessment and device removal.
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Minimum age
3
Months
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Maximum age
12
Months
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
1. Unclear diagnosis at presentation.
2. Chronic medical condition or other clinical safety concern, including but not limited to congenital heart disease or chronic lung disease.
3. Gestational age less than 37 weeks.
4. Any concern regarding child safety or welfare.
5. Requirement for oxygen supplementation after Emergency Department observation.
6. Requirement for intravenous antibiotics or ongoing nasogastric or intravenous rehydration.
7. Does not live within one hour’s drive of the hospital.
8. Poor or unreliable internet connectivity that cannot be resolved by the study team or the parent/legal guardian, for participants allocated to the virtual care arm.
9. Previously recruited to the study.
10. Practical barriers that cannot be reasonably addressed and would prevent safe home monitoring or timely return to hospital if escalation is required.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using REDCap. The randomisation sequence will be generated by an independent statistician not involved in recruitment or study delivery. Recruiters will only receive the group allocation in REDCap after eligibility has been confirmed, informed consent has been obtained, and the participant has been enrolled. Upcoming allocations will be concealed from study personnel.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence will be prepared by an independent statistician. Participants will be randomised in a 1:1 ratio to either the virtual EDSSU intervention arm or the physical EDSSU control arm. Randomisation will use permuted blocks of varying size, including block sizes of two, four and six.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The sample size is based on a two-arm non-inferiority randomised controlled trial comparing virtual EDSSU care at home with standard physical EDSSU admission. Participants will be randomised in a 1:1 allocation ratio. The primary outcome is the proportion of participants requiring oxygen therapy within 7 days of randomisation. Assuming no true difference between groups, an estimated primary outcome event rate of 30% in both arms, an absolute non-inferiority margin of 13 percentage points, 80% power, and a one-sided 95% confidence interval equivalent to a two-sided 90% confidence interval, 308 participants are required, with 154 participants per arm. Allowing for 5% attrition or withdrawal gives a total sample size of 326 participants, with 163 participants per arm. Non-inferiority will be declared if the upper limit of the confidence interval for the difference in proportions requiring oxygen therapy between the virtual EDSSU and physical EDSSU arms does not exceed 13 percentage points. Analyses will include intention-to-treat and per-protocol analyses.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2026
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Actual
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Date of last participant enrolment
Anticipated
31/07/2028
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Actual
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Date of last data collection
Anticipated
8/08/2028
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Actual
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Sample size
Target
326
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Translational Research Grants Scheme, administered by Ministry of Health NSW
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Government body
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Name
Sydney Children's Hospital Network
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
324963
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Sydney Children's Hospitals Network Human Research Ethics Committee
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Ethics committee address [1]
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http://www.schn.health.nsw.gov.au/health-professionals/our-research/ethics-research-governance
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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28/03/2026
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Approval date [1]
320608
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16/06/2026
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Ethics approval number [1]
320608
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026/ETH00656
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Summary
Brief summary
Brief summary Bronchiolitis is a common chest infection in infants and some babies need short-term hospital observation in an Emergency Department Short-Stay Unit. This study will test whether selected infants with mild bronchiolitis who need short-stay observation can be safely cared for at home through a virtual Emergency Department Short-Stay Unit model. Infants in the virtual care group will receive hospital-level care at home using wearable monitoring devices that continuously measure oxygen levels, heart rate and breathing rate. They will also receive regular virtual nursing observations, daily paediatrician-led virtual ward rounds and 24-hour access to the virtualKIDS clinical support line. This will be compared with usual care in a physical hospital Emergency Department Short-Stay Unit. The main purpose of the study is to determine whether virtual short-stay care at home is not worse than hospital short-stay care in terms of the need for oxygen treatment within 7 days. The study will also look at safety, hospital re-presentations, length of stay, family and clinician experience, and costs. Study hypothesis We hypothesise that, for carefully selected infants with mild bronchiolitis, virtual Emergency Department Short-Stay Unit care at home with wearable monitoring and regular clinical review will be non-inferior to physical Emergency Department Short-Stay Unit admission, as measured by the need for oxygen therapy within 7 days of randomisation.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Jagdev Singh
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Address
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virtualKIDS, Level 2, The Children's Hospital at Westmead, Cnr Hawkesbury and Hainsworth Street, Westmead, NSW 2145
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Country
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Australia
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Phone
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+61437325842
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Jagdev Singh
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Address
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virtualKIDS, Level 2, The Children's Hospital at Westmead, Cnr Hawkesbury and Hainsworth Street, Westmead, NSW 2145
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Country
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Australia
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Phone
151039
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+61437325842
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Jagdev Singh
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Address
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virtualKIDS, Level 2, The Children's Hospital at Westmead, Cnr Hawkesbury and Hainsworth Street, Westmead, NSW 2145
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Country
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Australia
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Phone
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+61437325842
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Fax
151040
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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