Respiratory Insufficiency in ChildrenDiaWorkHFNCNCT06249009
Diaphragmatic Work During HFNC and CPAP Support
A study testing Non invasive ventilation in people with Respiratory Insufficiency in Children and Newborn Rds, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this randomised controlled, cross-over clinical trial is to compare High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg with respiratory failure. Read more about this study
- Who is it for?
- Ages 34 weeks to 6 years
- Conditions the study is for
- Respiratory Insufficiency in Children, Newborn Rds, Nasal Cannula
- What is being tested?
- Non invasive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 27 Nov 2023to 27 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 weeks to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns over 34 SA and paediatric patients weighing less than 20 kg.
- Need for ventilatory support by HFNC or CPAP for respiratory failure
- Need for enteral feeding via nasogastric tube
- Hospitalized in PICU or NICU at Clermont-Ferrand University Hospital,
- Covered by Social Security.
- Whose parents or guardians are able to provide informed consent to participate in the research.
Who cannot join
- Respiratory failure requiring immediate intubation.
- Use of HFNC or CPAP as a relay to extubation.
- Acquired or congenital abnormality of the gastrointestinal tract.
- Diaphragmatic paralysis and/or neuromuscular pathology
- Failure of central ventilatory control (e.g. intra-ventricular haemorrhage, anoxic-ischaemic encephalopathy, massive vascular accident, intracranial process, cerebral edema and/or intracranial hypertension).
- Contraindications listed in the CPAP and HFNC user manuals: absence of spontaneous ventilation, choanal atresia, diaphragmatic hernia, tracheo-oesophageal fistula, nasal trauma, severe deformity likely to be aggravated by the nasal mask or nasal cannula, pneumothorax, pneumencephaly, Cerebrospinal Fluid leak, hypotension.
- Refusal by parents or guardians.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Nadia Savy
About this study
Official title: Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population: Non-inferiority Study
The goal of this randomised controlled, cross-over clinical trial is to compare High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg with respiratory failure.
The main question it aims to answer is the non-inferiority of high flows of high-flow nasal cannula compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of diaphragm)).
Participants with respiratory failure and need of non invasive ventilation and nasogastric tube will receive 4 different increasing flows of HFNC and Positive End-Expiratory Pressure of 7 cmH2O with CPAP during 30 minutes for each flow rate and CPAP. The electrical activity of diaphragm and clinical data of the patient upon each flow and support will be collected. According to the cross-over procedure, the patients will change groups (increasing flows of HFNC or CPAP) in order to perform the remaining analysis.
Read the detailed description
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:
- NICU patient: Optiflow Junior 2®.
- PICU patient: Optiflow Junior 2®, Optiflow +®.
Concerning CPAP ventilation:
- For the neonatal population:
- Medin Sindi® CPAP masks, caps and ties
- Medin Miniflow® CPAP generators
- For the paediatric population :
- Medin Sindi® CPAP masks, caps and ties
- Fisher and Paykel Healthcare CPAP masks, cannulas and caps
- Miniflow® CPAP generators from Medin
- Fisher and Paykel Healthcare CPAP generators
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).
- Being tested
- Non invasive ventilation
- Keywords
- Paediatric, HFNC, CPAP, work of breathing, primary support
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive ventilationDevice
CPAP and increasing flows of HFNC will be compared during a 30-minutes period each
| Study group | Role | What they receive |
|---|---|---|
| CPAP-first group | Active comparator | After a wash out of 15 minutes with conventional oxygen therapy, CPAP with a Positive End -Expiratory Pressure of 7 cmH2O will be introduced, with an inspiratory oxygen fraction required for an oxygen saturation of 94%, during 30 minutes. The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, Respiratory rate (RR), SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30. Receives: Device: Non invasive ventilation |
| HFNC-first group | Active comparator | After a wash out of 15 minutes with conventional oxygenotherapy, increasing flow rates for up to 2 hours according to the following augmentation:
* Initiation at a flow rate of 2 L/kg/min with FiO2 required to achieve SpO2≥94% (increase FiO2 if reliable SpO2 signal <94% for 1 minute) for 30min.
* Increase to 3 L/kg/min after the first 30min of ventilation and repeat the previously described experimental scheme.
* Further increase to 4 L/kg/min after 30min of ventilation and repetition of the experimental scheme (if weight < 16 kg).
* Last increase to 5 L/kg/min after 30 min of ventilation and repetition of the experimental scheme (if weight < 13 kg).
The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, RR, SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30. Receives: Device: Non invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP
Maximal EAdi will be measured in µV
Measured: Maximal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)
Secondary outcomes (10)
Variation in mean minimum EAdi (EAdi min) between different HFNC flows and between each HFNC flow and CPAP
Minimum EAdi will be measured in µV
Measured: Minimal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)
Variations of heart rate between the different rates of HFNC and between each rate of HFNC and CPAP
Heart rate will be measured in beats per minute (bpm)
Measured: every 5 minutes during 3 hours
Variations of respiratory rate between the different rates of HFNC and between each rate of HFNC and CPAP
Respiratory rate will be measured in breath per minute
Measured: every 5 minutes during 3 hours
Variations of oxygen saturation between the different rates of HFNC and between each rate of HFNC and CPAP
Oxygen saturation will be measured in percentage
Measured: every 5 minutes during 3 hours
Variations of transcutaneous partial pressure of carbon dioxide between the different rates of HFNC and between each rate of HFNC and CPAP
Transcutaneous partial pressure of carbon dioxide will be measured in mmHg
Measured: every 5 minutes during 3 hours
Variations of respiratory distress score between the different rates of HFNC and between each rate of HFNC and CPAP
score of Silverman (0 to 10), or score modified Wood score (0 to 10) or score of PRAM (0 to 12) depending on the pathology
Measured: Every 30 minutes during 3 hours
Incidence of minor side effects for each HFNC flow rate and for CPAP
bloating and/or gastrointestinal discomfort with no other associated cause, low-grade skin trauma
Measured: Every 30 minutes during 3 hours
Incidence of major side effects for each flow of HFNC and for CPAP
Barotrauma to the chest, pneumothorax or pneumomediastinum
Bradycardia defined as :
if < 1 year: Heart rate (HR) < 100 bpm for 20 seconds or < 60 bpm for 5 seconds if ≥ 1 year: HR < 100 bpm for 20 seconds or < 40 bpm for 5 seconds Number of desaturations (oxygen saturation rate (SpO2) < 88% for 3s), apneas (breathing pause ≥ 10s) High-grade skin trauma
Measured: Every 30 minutes during 3 hours
Intubation rate
Measured: through patient follow-up period, up to 3 hours
Ventilatory weaning time
Weaning from all types of pressure support
Measured: From date of randomization until the date of pressure weaning support, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start27 Nov 2023
- Primary completion27 Nov 2025 (estimated)
- Study completion27 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory Insufficiency in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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 from 2L/kg/min to 5 L/kg/min with 30 minutes of study for each flow. After a wash-out period of 15 minutes, according to the cross-over procedure, the patients will change groups in order to perform the remaining analysis.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Maquet Critical Care AB, Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- Nadia Savy, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06249009
- Sponsor's protocol ID
- AOI 2022 SAVY
- Acronym
- DiaWorkHFNC
- Status last verified
- Jun 2023
- First submitted
- 28 Sep 2023
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615.
PubMed 35707984Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
PubMed 28124736Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.
PubMed 30343318Nasef N, El-Gouhary E, Schurr P, Reilly M, Beck J, Dunn M, Ng E. High-flow nasal cannulae are associated with increased diaphragm activation compared with nasal continuous positive airway pressure in preterm infants. Acta Paediatr. 2015 Aug;104(8):e337-43. doi: 10.1111/apa.12998. Epub 2015 Apr 13.
PubMed 25759095Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
PubMed 24846750
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population: Non-inferiority Study
- ClinicalTrials.gov ID
- NCT06249009
- Acronym / sponsor ID
- DiaWorkHFNC / AOI 2022 SAVY
- Keywords
- Paediatric, HFNC, CPAP, work of breathing, primary support
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Maquet Critical Care AB, Fisher and Paykel Healthcare
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 27 Nov 2025 (estimated)
- Study completion
- 27 Nov 2025 (estimated)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomised controlled, cross-over clinical trial is to compare High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg with respiratory failure.
The main question it aims to answer is the non-inferiority of high flows of high-flow nasal cannula compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of diaphragm)).
Participants with respiratory failure and need of non invasive ventilation and nasogastric tube will receive 4 different increasing flows of HFNC and Positive End-Expiratory Pressure of 7 cmH2O with CPAP during 30 minutes for each flow rate and CPAP. The electrical activity of diaphragm and clinical data of the patient upon each flow and support will be collected. According to the cross-over procedure, the patients will change groups (increasing flows of HFNC or CPAP) in order to perform the remaining analysis.
Detailed description
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:
- NICU patient: Optiflow Junior 2®.
- PICU patient: Optiflow Junior 2®, Optiflow +®.
Concerning CPAP ventilation:
- For the neonatal population:
- Medin Sindi® CPAP masks, caps and ties
- Medin Miniflow® CPAP generators
- For the paediatric population :
- Medin Sindi® CPAP masks, caps and ties
- Fisher and Paykel Healthcare CPAP masks, cannulas and caps
- Miniflow® CPAP generators from Medin
- Fisher and Paykel Healthcare CPAP generators
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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 from 2L/kg/min to 5 L/kg/min with 30 minutes of study for each flow. After a wash-out period of 15 minutes, according to the cross-over procedure, the patients will change groups in order to perform the remaining analysis.
| Arm | Type | Receives |
|---|---|---|
| CPAP-first group | Active comparator | Device: Non invasive ventilationAfter a wash out of 15 minutes with conventional oxygen therapy, CPAP with a Positive End -Expiratory Pressure of 7 cmH2O will be introduced, with an inspiratory oxygen fraction required for an oxygen saturation of 94%, during 30 minutes. The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, Respiratory rate (RR), SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30. |
| HFNC-first group | Active comparator | Device: Non invasive ventilationAfter a wash out of 15 minutes with conventional oxygenotherapy, increasing flow rates for up to 2 hours according to the following augmentation: * Initiation at a flow rate of 2 L/kg/min with FiO2 required to achieve SpO2≥94% (increase FiO2 if reliable SpO2 signal <94% for 1 minute) for 30min. * Increase to 3 L/kg/min after the first 30min of ventilation and repeat the previously described experimental scheme. * Further increase to 4 L/kg/min after 30min of ventilation and repetition of the experimental scheme (if weight < 16 kg). * Last increase to 5 L/kg/min after 30 min of ventilation and repetition of the experimental scheme (if weight < 13 kg). The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, RR, SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30. |
Who may qualify
- Ages
- 34 weeks to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Newborns over 34 SA and paediatric patients weighing less than 20 kg.
- Need for ventilatory support by HFNC or CPAP for respiratory failure
- Need for enteral feeding via nasogastric tube
- Hospitalized in PICU or NICU at Clermont-Ferrand University Hospital,
- Covered by Social Security.
Key exclusion criteria (7 listed)
- Respiratory failure requiring immediate intubation.
- Use of HFNC or CPAP as a relay to extubation.
- Acquired or congenital abnormality of the gastrointestinal tract.
- Diaphragmatic paralysis and/or neuromuscular pathology
- Failure of central ventilatory control (e.g. intra-ventricular haemorrhage, anoxic-ischaemic encephalopathy, massive vascular accident, intracranial process, cerebral edema and/or intracranial hypertension).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive ventilationCPAP and increasing flows of HFNC will be compared during a 30-minutes period each | Device | CPAP-first group, HFNC-first group |
Primary outcome
Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP
Time frame: Maximal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)
Maximal EAdi will be measured in µV
10 secondary outcomes
Variation in mean minimum EAdi (EAdi min) between different HFNC flows and between each HFNC flow and CPAP
Time frame: Minimal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)
Variations of heart rate between the different rates of HFNC and between each rate of HFNC and CPAP
Time frame: every 5 minutes during 3 hours
Variations of respiratory rate between the different rates of HFNC and between each rate of HFNC and CPAP
Time frame: every 5 minutes during 3 hours
Variations of oxygen saturation between the different rates of HFNC and between each rate of HFNC and CPAP
Time frame: every 5 minutes during 3 hours
Variations of transcutaneous partial pressure of carbon dioxide between the different rates of HFNC and between each rate of HFNC and CPAP
Time frame: every 5 minutes during 3 hours
Variations of respiratory distress score between the different rates of HFNC and between each rate of HFNC and CPAP
Time frame: Every 30 minutes during 3 hours
Incidence of minor side effects for each HFNC flow rate and for CPAP
Time frame: Every 30 minutes during 3 hours
Incidence of major side effects for each flow of HFNC and for CPAP
Time frame: Every 30 minutes during 3 hours
Intubation rate
Time frame: through patient follow-up period, up to 3 hours
Ventilatory weaning time
Time frame: From date of randomization until the date of pressure weaning support, up to 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Background: PubMed 35707984Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615.
- Results publication: PubMed 28124736Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.
- Results publication: PubMed 30343318Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.
- Results publication: PubMed 25759095Nasef N, El-Gouhary E, Schurr P, Reilly M, Beck J, Dunn M, Ng E. High-flow nasal cannulae are associated with increased diaphragm activation compared with nasal continuous positive airway pressure in preterm infants. Acta Paediatr. 2015 Aug;104(8):e337-43. doi: 10.1111/apa.12998. Epub 2015 Apr 13.
- Results publication: PubMed 24846750Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Savy principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive ventilation in people with Respiratory Insufficiency in Children and Newborn Rds, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP (time frame: Maximal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06249009, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.