SWISH Trial (Strategies for Weaning Infants on Supportive High Flow)

NCT04287959 | Completed DMC

• 1 other identifier: 19/OCT/7769
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. In older children and adults, the same viruses that cause bronchiolitis lead to the 'common cold'. The symptoms of bronchiolitis are like a common cold and include a blocked or runny nose, a cough and a mildly raised temperature. Bronchiolitis affects the bronchioles which are the smaller breathing tubes in the lungs. They produce more mucus than usual and become swollen, leading to a cough and a runny nose. In more severe cases, the tubes become clogged up with mucus which causes breathing problems. In some babies, the breathing problems may present as breathing fast, with in-drawing of the muscles around the rib cage, and in rare cases, very young babies with bronchiolitis may stop breathing for brief periods ('apnoea'). The illness usually starts with a mild runny nose or cough, gets worse over three to five days or so, and then slowly gets better, usually lasting about 10 to 14 days in total. Around 2 in 100 infants with bronchiolitis will need to spend some time in hospital during the course of their illness. This is usually for one of two reasons: they need oxygen treatment to keep their oxygen saturations within acceptable levels or they cannot manage to feed from the breast or a bottle because of a blocked nose or difficulty breathing. Here at the Children's Hospital for Wales we are using 'High flow' to deliver oxygen. This is a relatively new concept on the general paediatric wards, and more established in a setting such as High Dependency Unit (HDU). However, we have been using it successfully on the wards for the last 3 years. High flow device delivering a mixture of oxygen and air at high flow to help open the child's airways so that their lungs can add oxygen to their blood. It is given through a set of prongs (short plastic tubes) inserted just inside the nostrils. Research has shown that the early use of high flow can reduce the chances of the child needing escalation of care to a high dependency unit or paediatric intensive care unit. The investigators are interested in studying the process of weaning high flow support once the child is over the worst of their illness. This will enable the investigators to use the most effective method of weaning babies from their high flow, and ready for discharge. This has the potential to reduce the number of hours spent in hospital for babies and their parents or guardians.

Conditions

Respiratory Disease; Bronchiolitis, Viral; Infant Morbidity

Outcome Measures

Primary Outcomes (4)

• Examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC.

  we will assess the following objective in this feasibility trial: • identify the proportion of eligible patients approached who consent to the study; We will use a traffic light system to determine progress to a multi-centre RCT.

  This will be during the recruitment time of the study (2 years)

• Identify the proportion of recruited patients who supply secondary outcome data.

  We will assess the following objective: identify the proportion (percentage) of recruited patients who supply primary outcome data(time spent in hospital).

  This will be during the recruitment time of the study (2 years)

• Assess the adherence of the teams on the ward to the weaning protocol assigned during randomisation.

  We will assess the following objective: to review the adherence to the weaning protocol assigned during randomisation, in particular if this can be complied with in a ward setting with a large number of healthcare staff. This will be measured as a yes or no response and calculated as a percentage/proportion.

  This will be during the recruitment time of the study (2 years)

• Assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff.

  We will assess the following objectives: to assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff via questionnaires only.

  This will be during the recruitment time of the study (2 years)

Secondary Outcomes (2)

• Time taken to wean off the highflow machine as measured in minutes and hours.

  This will be during the recruitment time of the study (2 years)

• To assess the safety of the different weaning strategies used.

  This will be over the 2 years of recruitment time of the study.

Study Arms (2)

A: wean to 30%

ACTIVE COMPARATOR

wean to 30% oxygen on high flow and then turn off high flow support and place onto standard low flow oxygen.

Device: High flow nasal cannula support

B: wean to 21%

ACTIVE COMPARATOR

wean to 21% oxygen on high flow and then turn off high flow support and place directly into air.

Device: High flow nasal cannula support

Interventions

High flow nasal cannula support DEVICE

airvo2 highflow devices will be used.

A: wean to 30%; B: wean to 21%

Eligibility Criteria

• Age: 4 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Clinical diagnosis of bronchiolitis
• Age \>4 weeks and \<12 months
• Needs HFNC respiratory support in a ward setting for more than 12 hours

You may not qualify if:

• Requirement for imminent intubation and ventilation or having received mechanical ventilation during the current hospital admission
• Requirement for imminent CPAP support
• Pre-existing or concomitant, non-viral respiratory infection
• Pre-existing respiratory disease
• Ready to wean high-flow after \<12 hours of its initiation
• Weight \>10kg
• Low level of consciousness
• Apnoeas\*
• Cyanotic heart disease
• Basilar skull fracture
• Upper airway obstruction
• Craniofacial malformations
• Infants on home oxygen
• Ex-premature infants (born at \<32 weeks gestation)

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Children's Hospital for Wales

Cardiff, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Towriss C, Dafydd C, Edwards M. High-flow weaning strategies for infants with bronchiolitis: protocol for a pilot randomised controlled trial in the UK. BMJ Open. 2024 Nov 9;14(11):e087672. doi: 10.1136/bmjopen-2024-087672.

  PMID: 39521467 DERIVED

MeSH Terms

Conditions

Respiration Disorders; Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchiolitis; Bronchitis; Respiratory Tract Infections; Infections; Virus Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Martin O Edwards, PhD, BM

  CAVUHB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Given this is a pilot study, a recruitment target has not been set. Instead the study will aim to assess recruitment success which will inform a larger multicentre trial if deemed feasible

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 27, 2020
• Study Start: October 6, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)