First-line support for assistance in breathing in childre

Not Applicable

Completed

• Conditions: on-invasive respiratory support in paediatric critical care; Respiratory

• Registration Number: ISRCTN60048867
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Study Completion: 2022-11-07
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1200

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)

Previous participant exclusion criteria:
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to liberation from respiratory support, defined as the start of a 48-hour period during which the child was free of all forms of respiratory support