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FIRST-line Support for Assistance in Breathing in Children (FIRST-ABC) Feasibility Study

NCT02612415 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2016-12-16

No results posted yet for this study

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

Conditions

  • Hypoxia
  • Respiratory Acidosis
  • Moderate/Severe Respiratory Distress

Interventions

DEVICE

Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula

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

DEVICE

Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure

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

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • Intensive Care National Audit & Research Centre

    collaborator OTHER

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Padmanabhan Ramnarayan · Consultant in Paediatric Intensive Care & Retrieval Children's Acute Transport Service (CATS)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
36 Weeks
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-10-31
Completion
2016-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02612415 on ClinicalTrials.gov