NCT02457013

Brief Summary

  1. 1.The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
  2. 2.Design: non-inferiority study, prospective, controlled, randomized, multi-center.
  3. 3.Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS \>3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
  4. 4.Conditions of measurements:
  5. 5.Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
  6. 6.Study Schedule: October 2014-April 2016

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2015

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 29, 2015

Status Verified

May 1, 2015

Enrollment Period

1.5 years

First QC Date

January 27, 2015

Last Update Submit

May 26, 2015

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • Proportion of failure

    Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

    24 hours

Secondary Outcomes (12)

  • number of participants with an aggravation of the clinical score for respiratory distress arms

    1hour

  • number of participants with an aggravation of the clinical score for respiratory distress arms

    12hours

  • number of participants with an increase of the clinical score for respiratory distress arms

    1 hour

  • Comparison of the Report Sp02/Fi02 in both arms

    1 hour

  • Comparison of the Report Sp02/Fi02 in both arms

    12 hours

  • +7 more secondary outcomes

Study Arms (2)

HFNC treatment

EXPERIMENTAL

HFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours)

Device: HFNC

nCPAP treatment

ACTIVE COMPARATOR

nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours)

Device: nCPAP

Interventions

HFNCDEVICE

Hygh flow nasal canula HFNC

HFNC treatment
nCPAPDEVICE

nasal nCPAP

nCPAP treatment

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • age\<6months
  • bronchiolitis
  • mWCAS \> or=3
  • hospitalisation in pediatric intensive care unit
  • signed consent form (2 parents)

You may not qualify if:

  • Intubated patient
  • Neurological or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Montpellier

Montpellier, 34395, France

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Central Study Contacts

Christophe MILESI, Doctor

CONTACT

0033467336609c-milesi@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2015

First Posted

May 29, 2015

Study Start

October 1, 2014

Primary Completion

April 1, 2016

Study Completion

November 1, 2016

Last Updated

May 29, 2015

Record last verified: 2015-05

Locations

FR(1)