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Clinical Trials/ISRCTN60048867
ISRCTN60048867
Completed
未知

FIRST-line support for Assistance in Breathing in Children (FIRST-ABC): a master protocol of two randomised trials to evaluate the non-inferiority of high flow nasal cannula (HFNC) versus continuous positive airway pressure (CPAP) for non-invasive respiratory support in paediatric critical care

Great Ormond Street Hospital for Children NHS Foundation Trust0 sites1,200 target enrollmentJune 19, 2019
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Conditionson-invasive respiratory support in paediatric critical careRespiratory

Overview

Phase
未知
Intervention
Not specified
Conditions
on-invasive respiratory support in paediatric critical care
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
Enrollment
1200
Status
Completed
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32753452/ protocol (added 05/08/2020) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35390113/ Step-down RCT results (added 08/04/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35707984/ Step-up RCT results (added 17/06/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38848138/ Cost-Effectiveness (added 11/06/2024)

Registry
who.int
Start Date
June 19, 2019
End Date
November 7, 2022
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. Admitted/accepted for admission to PICU/HDU
  • •2\. Age \> 36 weeks corrected gestational age and \< 16 years
  • •3\. Assessed by the treating clinician to require non\-invasive respiratory support, EITHER
  • •3\.1\. For an acute illness (step\-up RCT) OR
  • •3\.2\. Within 72 hours of extubation following a period of invasive ventilation (step\-down RCT)

Exclusion Criteria

  • •Current participant exclusion criteria as of 02/03/2020:
  • •1\. Assessed by the treating clinician to require immediate intubation and invasive ventilation due to severe hypoxia, acidosis and/or respiratory distress, upper airway obstruction, difficulty managing airway secretions or recurrent apnoeas
  • •2\. Tracheostomy in place
  • •3\. Received HFNC/CPAP for \> 2 hours in the prior 24 hours
  • •4\. On home non\-invasive ventilation prior to PICU/HDU admission
  • •5\. Presence of untreated air\-leak (pneumothorax and/or pneumomediastinum)
  • •6\. Midfacial/craniofacial anomalies (unrepaired cleft palate, choanal atresia) or recent craniofacial surgery
  • •7\. Agreed ‘not for intubation’ or other limitation of critical care treatment plan in place.
  • •8\. Previously recruited to the FIRST\-ABC trial
  • •9\. Clinician decision to start other form of non\-invasive respiratory support (i.e. not HFNC or CPAP)

Outcomes

Primary Outcomes

Not specified

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