With this research protocol, the investigators aim to demonstrate the non-inferiority of high
flows of HFNC compared with CPAP on work of breathing (based on the intensity of contraction
of diaphragmatic fibres and clinical aspects) in paediatric and neonatal patients. The
investigators will also study the clinical tolerance and safety of these practices.
Objectives :
Main objective: To demonstrate the non-inferiority of high-flow nasal cannula flow rates
compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of
diaphragm)) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20
kg in respiratory failure.
Secondary objectives:
To compare different flows of HFNC (2 L/kg/min, 3 L/kg/min, 4 L/kg/min, 5 L/kg/min) with
each other by analysing diaphragmatic contraction.
Compare the clinical effectiveness of different flow rates of HFNC with CPAP in young
children in respiratory distress.
To compare the tolerability of different flow rates of HFNC with CPAP in the population
of young children suffering from respiratory distress.
To compare the incidence of minor (digestive discomfort, digestive bloating,
non-damaging skin lesions) and major (thoracic barotrauma, damaging skin lesions) side
effects of different flow rates of HFNC with CPAP in young children in respiratory
distress.
To describe the choice of support and settings (flow rates or PEEP levels) made by the
practitioners in charge of the child after the study period.
To describe the epidemiological data from the paediatric intensive care and monitoring
units and the neonatal intensive care unit.
Type of study: Randomised controlled, cross-over, single-centre, non-inferiority trial of a
medical device.
Number of centres: 1
Study design:
Upon admission to the department, if the eligibility criteria are met and the parents agree
to the research , a wash-out period will be performed under low-flow oxygen therapy at 1
L/min to achieve SpO2 ≥ 94% for 15 minutes.
The included patients will then be randomized into two separate groups: a CPAP group with
PEEP at 7 cmH2O for 30 minutes and an HFNC group with increasing flow rates for up to 2
hours.
The patients included will be their own controls and at the end of the first analysis,
according to the cross-over procedure, the patients will change groups in order to perform
the remaining analysis.
A recourse procedure has been foreseen in case of failure of ventilatory support.
Medical devices :
Concerning HFNC ventilation:
The nasal cannulas used are Optiflow® cannulas (Fisher and Paykel Laboratory) which will be
adapted to the size of each patient's nostrils. The following sizes are available:
Concerning CPAP ventilation:
Expected benefits :
If it is shown that a reduction in the work of breathing is observed (EAdi and usual clinical
signs) when HFNC flow rates are gradually increased, and that this increase to flow rates of
3 to 5 L/kg/min is well tolerated and does not increase the risk of barotrauma, HFNC
ventilation at flow rates greater than 2 L/kg/min could be more widely proposed and accepted
in the various units using it, as it is unanimously accepted in terms of tolerance and
comfort for the patient compared with CPAP.
Recruitment procedures The patients eligible for this study will be those admitted to the
neonatal and paediatric intensive care unit of the Clermont-Ferrand University Hospital by a
doctor on the unit and who meet the various inclusion criteria for the study.
An information note has been drawn up and will be presented and explained to the child's
legal representative(s) by an investigating doctor during their usual care, as well as to the
child if his or her level of understanding is adequate, within 2 hours of admission to the
department. The parents and the child will have a maximum of 1 hour to reflect (and a maximum
of 3 hours from admission to the ward) between the time they are given the information and
the time they sign the consent form.
Legal representative(s) will then be asked to sign the written consent. The child's inclusion
in the DiaworkHFNC protocol will be recorded in the child's computerised medical record (ICCA
software).