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Nasal High Flow Therapy in the Paediatric Home Setting (HFNC)

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ClinicalTrials.gov Identifier: NCT04037839
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
Fisher and Paykel Healthcare
Information provided by (Responsible Party):
Patrick Stafler, Rabin Medical Center

Brief Summary:

High flow nasal cannula (HFNC) therapy is non-invasive respiratory support designed to deliver a high flow of heated humidified air, with or without entrained oxygen, via specifically designed nasal prongs. Initially developed for preterm infants, the application of the technology is rapidly spreading to include pediatric patients with various indications, including bronchiolitis, obstructive sleep apnea (OSA), tracheomalacia, asthma, post- extubation support, and even adult hypoxemic respiratory failure.

Since it appears to be better tolerated than traditional modes of non-invasive ventilation, such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), it is increasingly used outside the intensive care setting, despite limited evidence of its safety and efficacy. In Israel, HFNC is approved for home support of children requiring non-invasive respiratory support on the recommendation of a paediatric pulmonologist or intensivist, provided that CPAP and BiPAP have been trialed and deemed not tolerated by the patient.

At Schneider Childrens' Medical Center of Israel (SCMI), a tertiary paediatric hospital, therapy is commenced during a brief inpatient stay, at a period of clinical stability. Parents are trained in the use of the device and flow rate is titrated to clinical response.

The investigators aim to describe the safety, indications, parameters of utilization, length of treatment, clinical outcomes and parental satisfaction of HFNC in the paediatric home setting.


Condition or disease Intervention/treatment
Respiratory Disease Lung Diseases Other: Questionnaire

Detailed Description:

High flow nasal cannula (HFNC) therapy is non-invasive respiratory support designed to deliver a high flow of heated humidified air, with or without entrained oxygen, via specifically designed nasal prongs. Its physiological benefits include flow-dependent positive airway pressure, alveolar recruitment and washout of carbon dioxide from the upper airway. The reduction of esophageal pressure changes during respiration, compared with standard non-occlusive oxygen facemask, indicates its capacity to ease inspiratory effort.

Initially developed for preterm infants, the application of this technology is rapidly spreading to include pediatric patients with various indications, including bronchiolitis, obstructive sleep apnea (OSA), tracheomalacia, asthma, post-extubation support, and even adult hypoxemic respiratory failure.

Since it appears to be better tolerated than traditional modes of non-invasive ventilation, such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), it is increasingly used outside the intensive care setting, despite limited evidence of its safety and efficacy.

In Israel, HFNC is approved for home support of children requiring non-invasive respiratory support on the recommendation of a paediatric pulmonologist or intensivist, provided that CPAP and BiPAP have been trialed and deemed not tolerated by the patient. At Schneider Childrens' Medical Center of Israel (SCMI), a tertiary paediatric hospital, therapy is commenced during a brief inpatient stay, at a period of clinical stability. Parents are trained in the use of the device and flow rate is titrated to clinical response.

The investigators aim to describe the safety, indications, parameters of utilization, length of treatment, clinical outcomes and parental satisfaction of HFNC in the paediatric home setting.

Medical records of children aged 0-18 years who were prescribed a HFNC device at Schneider Children's between 2014-2018 for use in the home setting will be reviewed retrospectively. Demographic and clinical data will be collected. This will be supplemented by a standardized telephone questionnaire. Verbal consent will be obtained from one of the parents, and documented. As part of the telephone consent process, parents will be offered to "opt out" at the beginning of the interview.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: High Flow Nasal Cannula Therapy in the Paediatric Home Setting
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Questionnaire
    Medical records of children aged 0-18 years who were prescribed a HFNC device at Schneider Children's between 2014-2018 for use in the home setting will be reviewed retrospectively. As part of the telephone consent process, parents will be offered to "opt out" at the beginning of the interview.


Primary Outcome Measures :
  1. Change in cumulative days of hospital admission [ Time Frame: 6 months before compared to 6 months after starting high flow nasal cannula treatment ]
    For all participants, 2 periods will be compared in terms of days of hospital admissions



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants and pediatric patients
Criteria

Inclusion Criteria:

  1. Any child who received HFNC
  2. Previously trialed CPAP and BiPaP and deemed not tolerated by patient.

Exclusion Criteria:

N/A


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037839


Contacts
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Contact: Patrick Stafler 00972547243623 pstafler@hotmail.com
Contact: Zvia Dekel 00972523448341 zviade@clalit.org.il

Locations
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Israel
Schneider Children's Medical Center of Israel Recruiting
Petach Tikva, Israel, 49202
Contact: Patrick Stafler, MD    972547243623    pstafler@hotmail.com   
Sponsors and Collaborators
Rabin Medical Center
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Patrick Stafler Schneider Children's

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Responsible Party: Patrick Stafler, Senior Pulmonologist, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT04037839    
Other Study ID Numbers: Vapotherm
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Respiration Disorders
Respiratory Tract Diseases