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High-flow weaning strategies for infants with bronchiolitis: protocol for a pilot randomised controlled trial in the
Christopher Towriss1, Carwyn Dafydd2, Martin Edwards3,4
1Department of Acute Child Health, Children's Hospital for Wales, Cardiff, UK christopher.towriss2@wales.nhs.uk.
Insights
This pilot study investigates weaning strategies for infants with bronchiolitis using high-flow nasal cannula (HFNC) therapy. The goal is to determine the most effective method to reduce respiratory support duration and hospital stays.
Area of Science:
- Pediatric Respiratory Medicine
- Clinical Trials
- Critical Care
Background:
- High-flow nasal cannula (HFNC) therapy is effective for pediatric bronchiolitis but may prolong hospital stays due to unclear weaning protocols.
- Optimizing HFNC weaning strategies is crucial for improving patient outcomes and resource utilization in pediatric intensive care.
Purpose of the Study:
- To conduct a pilot randomized controlled trial to identify the most effective weaning strategy for infants (up to 12 months) with bronchiolitis on HFNC.
- To assess the feasibility of implementing different HFNC weaning protocols.
- To inform a larger multicenter trial for evidence-based practice.
Main Methods:
- An open-label, randomized controlled trial involving 20 infants at Noah's Ark Children's Hospital for Wales over 24 months.
- Comparison of two weaning strategies: high-flow only (discontinue at 21% FiO2) versus HFNC with low-flow (discontinue HFNC at 30% FiO2, transition to low-flow up to 2 L/min).
- HFNC delivered at 2 L/kg/min (max 20 L/min). Primary outcome: feasibility of weaning strategies. Secondary outcomes: time to discontinuation of respiratory support and safety.
Main Results:
- Feasibility of implementing and comparing two distinct HFNC weaning strategies in infants with bronchiolitis was assessed.
- Data on the time required to wean patients off respiratory support and the safety profiles of each strategy were collected.
- This pilot study provides preliminary data to guide future larger-scale investigations.
Conclusions:
- The pilot study demonstrated the feasibility of evaluating different high-flow nasal cannula weaning strategies in infants with bronchiolitis.
- Findings will inform the design of a larger multicenter trial to establish optimal weaning protocols.
- Effective weaning strategies have the potential to reduce respiratory support duration and length of hospital stay for pediatric patients.
Introduction:
Ward-based high-flow nasal cannula (HFNC) is an effective therapy for children with bronchiolitis who have failed standard oxygen therapy. However, HFNC can increase hospital length of stay perhaps because there is a lack of evidence to guide weaning strategies.We aim to conduct a pilot study to identify the most effective weaning strategy for infants, up to 12 months, supported on HFNC for bronchiolitis. This may lead to reduced time on respiratory support and shorter length of stay. If this pilot study is deemed feasible, it will inform a larger multicentre trial.
Methods And Analysis:
This open label, non-blinded, randomised controlled trial will be conducted over 24 months at the Noah's Ark Children's Hospital for Wales, Cardiff, and will aim to recruit 20 patients. It will compare high-flow only weaning (high-flow discontinued at FiO2 of 21%) to HFNC and low-flow weaning (HFNC discontinued at 30% and replaced by low-flow up to 2 L/min). HFNC therapy will be delivered at 2 L/kg/min (maximum 20 L/min). The primary outcome is to examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC. Secondary outcomes include the time from decision to wean HFNC to the patient no longer requiring respiratory support and a safety assessment of the weaning strategies.
Ethics And Dissemination:
Health Research Authority and Health and Care Research Wales approval was granted on 8 September 2020 following review by the NHS research ethics committee.The sponsor is Cardiff and Vale University Health Board. We will publish the results in a peer-reviewed medical journal, via websites and newsletters.
Trial Registration Number:
NCT04287959.
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