FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study
FIRST-ABC
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
1 other identifier
interventional
121
1 country
3
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2015
Shorter than P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedFirst Posted
Study publicly available on registry
November 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedDecember 16, 2016
December 1, 2016
11 months
October 23, 2015
December 15, 2016
Conditions
Outcome Measures
Primary Outcomes (6)
Number of eligible patients in Group A (step-up) and Group B (step-down)
Baseline
Number of parents/guardians who refuse prospective or deferred consent
Through study completion, an average of 24 hours
Randomising at least 50% of eligible patients
Baseline
Proportion of patients adherent to the study treatment
Through study completion, an average of 72 hours
Mean COMFORT score
72 hours
Number of parents completing the Parental Stressor Scale: PICU (PSS:PPICU)
24 hours
Secondary Outcomes (6)
Proportion of children randomised to the intervention or control who need intubation (Group A) or re-intubation (Group B)
72 hours
Proportion of children randomised to the intervention or control who fail the assigned treatment and require either crossover or escalation to other forms of ventilation
72 hours
Number of children who experience pre-specified adverse events (pneumothorax, pneumomediastinum, nasal or facial trauma, abdominal distension, nosocomial infection) during the period they are receiving non-invasive respiratory support
28 days
Improvement in oxygenation, partial pressure of carbon dioxide (pCO2) levels, heart rate, respiratory rate, and work of breathing
24 hours
Length of PICU and hospital stay, length of invasive ventilation, length of non-invasive support, ventilator-free days at day 28
through study completion, an average of 28 days
- +1 more secondary outcomes
Study Arms (2)
High flow nasal cannula (HFNC)
EXPERIMENTALHeated 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
Continuous positive airway pressure (CPAP)
ACTIVE COMPARATORContinuous positive airway pressure delivered using any interface (hood, mask or prongs)
Interventions
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
Eligibility Criteria
You may qualify if:
- Eligible patients will fall into one of two groups:
- Group A (Step-up)
- Age \>36 weeks corrected gestational age and \<16 years, AND
- Deemed to require non-invasive respiratory support by the treating clinician for an acute illness, AND
- 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)
- Age \>36 weeks corrected for gestation and \<16 years, AND
- 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.
You may not qualify if:
- 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
- Tracheostomy in place
- Pre-existing air-leak syndrome (pneumothorax/pneumomediastinum)
- Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or had recent craniofacial surgery
- Agreed limitation of intensive care treatment plan in place ('not for intubation')
- On domiciliary non-invasive ventilation prior to PICU admission
- Managed on either HFNC and/or CPAP (or other form of non-invasive ventilation such as BiPAP) in the preceding 24 hours
- Previously recruited to this study during the same PICU admission
- Cannot be treated with HFNC
- Unavailability of appropriate sized nasal prongs
- Unavailability of HFNC device
- Cannot be treated with CPAP
- Unavailability of right size of face mask, prong or other patient interface
- Unavailability of CPAP device
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Great Ormond Street Hospital for Children NHS Foundation Trustlead
- Imperial College Londoncollaborator
- Barts & The London NHS Trustcollaborator
- Intensive Care National Audit & Research Centrecollaborator
Study Sites (3)
Barts Health NHS Trust
London, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Related Publications (2)
Ramnarayan 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: 29866165DERIVEDRamnarayan 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: 28606907DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Padmanabhan Ramnarayan
Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2015
First Posted
November 23, 2015
Study Start
November 1, 2015
Primary Completion
October 1, 2016
Study Completion
December 1, 2016
Last Updated
December 16, 2016
Record last verified: 2016-12