FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study
Condition: Hypoxia; Respiratory Acidosis; Moderate/Severe Respiratory Distress
MeSH terms: Acidosis, Respiratory; Acidosis; Hypoxia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A feasibility study to inform the design and conduct of a randomised controlled trial of high
      flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive
      respiratory support in critically ill children
    

Detailed description: 
      Breathing support is the most common intervention provided to critically ill children in a
      paediatric intensive care unit (PICU). Although invasive breathing support (delivered through
      a tracheal tube) is lifesaving, concerns regarding its risks (infection and lung damage) have
      prompted greater use of non-invasive respiratory support (NRS). However, there is little
      scientific evidence to guide PICU clinicians on the comparative effectiveness of the commonly
      used modes of NRS.

      In this feasibility study, the investigators are testing whether it is possible to conduct a
      randomised clinical trial comparing two modes of NRS: continuous positive airway pressure
      (CPAP), which has been used for over two decades, and high flow nasal cannula (HFNC), a newer
      method of respiratory support. It is not known for sure how useful HFNC is in critically ill
      children because there is no published research comparing it with CPAP. However, since HFNC
      is easier to use and better tolerated by children, many hospitals are now using HFNC instead
      of CPAP. Before HFNC is widely adopted, a clinical trial to establish its role in the
      management of critically ill children is urgently needed.

      As part of this study, the investigators will randomly allocate children deemed to require
      NRS by their treating clinician to either HFNC or CPAP. The investigators will mainly assess
      whether sufficient number of children can be recruited to the trial, whether clinicians are
      willing to randomise children, and test the proposed treatment pathways for CPAP and HFNC.
      The trial will run over six months, and recruit 120 sick children from three National Health
      Service (NHS) hospitals. Consent will be sought from parents/guardians for their children to
      be included in the study, usually before CPAP or HFNC is started, unless emergency
      life-saving treatment is required, in which case consent will be deferred until there is more
      time to discuss the study with parents/guardians.
    

Intervention name(s): Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula; Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
Intervention type(s): Device; Device
Intervention description(s): A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support; CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment