Clinical trial · Interventional
FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study
FIRST-ABC Feasibility Study: Feasibility Study for a Randomised Trial of High Flow Nasal Cannula (HFNC) Versus Continuous Positive Airway Pressure (CPAP) for Non-invasive Respiratory Support in Critically Ill Children
NCT02612415CI-TRIAL-00025205FIRST-ABCcompletedPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hypoxia | — | UNRESOLVED | — |
| Moderate/Severe Respiratory Distress | — | UNRESOLVED | — |
| Respiratory Acidosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure | Device | — | UNRESOLVED |
| Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High flow nasal cannula (HFNC)
- description
- Heated humidified high flow nasal cannula therapy delivered at 2 L/kg/min gas flow rate (for children older than 10 kg in weight, an additional 0.5 L/kg/min per kilogram over 10 kg). Any approved device can be used to deliver HFNC
- interventionNames
- Device: Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula
- type
- ACTIVE_COMPARATOR
- label
- Continuous positive airway pressure (CPAP)
- description
- Continuous positive airway pressure delivered using any interface (hood, mask or prongs)
- interventionNames
- Device: Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure
Primary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 36 Weeks
- Maximum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria:
Eligible patients will fall into one of two groups:
Group A (Step-up)
1. Age \>36 weeks corrected gestational age and \<16 years, AND
2. Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
3. Satisfies one or more of the following criteria:
* Hypoxia (oxygen saturation \<92% in fraction of inspired oxygen (FiO2) \>0.40, or equivalent). FiO2 of 0.40 roughly equates to standard unhumidified nasal cannula oxygen delivered at 6 L/min or oxygen delivered via facemask without a rebreather bag at 6-10 L/min.
* Acute respiratory acidosis (pH \<7.3 with a concomitant pCO2 \>6.5 kPa)
* Moderate respiratory distress (use of accessory muscles, subcostal and intercostal recession, tachypnoea for age, grunting)
Group B (Step-down)
1. Age \>36 weeks corrected for gestation and \<16 years, AND
2. Deemed to require non-invasive respiratory support by the treating clinician after extubation, following a spell of invasive ventilation
* Either immediately after extubation as a 'planned' procedure, irrespective of clinical condition ('planned') OR
* Prompted by deterioration in clinical condition within 72 hours after extubation ('rescue'). Clinical parameters to assess the need for NRS in this situation will be similar to point 3 in Group A.
Exclusion Criteria:
1. Deemed by the treating clinician to require immediate intubation/invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction or recurrent apnoeas
2. Tracheostomy in place
3. Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
4. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
5. Agreed limitation of intensive care treatment plan in place ('not for intubation')
6. On domiciliary non-invasive ventilation prior to PICU admission
7. Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours
8. Previously recruited to this study during the same PICU admission
9. Cannot be treated with HFNC
* Unavailability of appropriate sized nasal prongs
* Unavailability of HFNC device
10. Cannot be treated with CPAP
* Unavailability of right size of face mask, prong or other patient interface
* Unavailability of CPAP deviceReferences
Publications (2)
- DERIVEDRamnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter RR, Wulff J, Harrison DA, Mouncey PM, Peters MJ; United Kingdom Paediatric Intensive Care Society Study Group (PICS-SG). FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a multicentre pilot randomised controlled trial of high-flow nasal cannula therapy versus continuous positive airway pressure in paediatric critical care. Crit Care. 2018 Jun 4;22(1):144. doi: 10.1186/s13054-018-2080-3. PMID 29866165
- DERIVEDRamnarayan P, Lister P, Dominguez T, Habibi P, Edmonds N, Canter R, Mouncey P, Peters MJ. FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): protocol for a multicentre randomised feasibility trial of non-invasive respiratory support in critically ill children. BMJ Open. 2017 Jun 12;7(6):e016181. doi: 10.1136/bmjopen-2017-016181. PMID 28606907