Respiratory DiseaseHFNCNCT04037839
Nasal High Flow Therapy in the Paediatric Home Setting
An observational study of Respiratory Disease and Lung Diseases, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Respiratory Disease, Lung Diseases
- What is being tested?
- Questionnaire
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 26 Mar 2019to Dec 2022
- Phase
- Observational
- 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 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Preterm infants and pediatric patients
Who may be able to join
- Any child who received HFNC
- Previously trialed CPAP and BiPaP and deemed not tolerated by patient.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Schneider Children's Medical Center of Israel
Petah Tikva, 49202
Patrick Stafler, MD, 972547243623, pstafler@hotmail.com
About this study
Official title: High Flow Nasal Cannula Therapy in the Paediatric Home Setting
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.
Read more
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.
Read the 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.
- Conditions
- Respiratory Disease, Lung Diseases
- Being tested
- Questionnaire
- Medical subject headings
- Respiration Disorders, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cumulative days of hospital admission
For all participants, 2 periods will be compared in terms of days of hospital admissions
Measured: 6 months before compared to 6 months after starting high flow nasal cannula treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start26 Mar 2019
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseaseStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Patrick Stafler, Rabin Medical Center
- Investigators
- Patrick Stafler, Principal investigator, Schneider Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037839
- Sponsor's protocol ID
- Vapotherm
- Acronym
- HFNC
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2019
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Therapy in the Paediatric Home Setting
- ClinicalTrials.gov ID
- NCT04037839
- Acronym / sponsor ID
- HFNC / Vapotherm
- Conditions
- Respiratory Disease, Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 Jul 2019 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Preterm infants and pediatric patients
Key inclusion criteria (2 listed)
- Any child who received HFNC
- Previously trialed CPAP and BiPaP and deemed not tolerated by patient.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| QuestionnaireMedical 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. | Other | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Respiratory Disease
RecruitingObservational study
A Multicenter Evaluation of SalivIQ™ Strep A for Detecting Group A Streptococcus From Saliva and Throat Swabs in Patients With Acute Pharyngitis
Streptococcal Pharyngitis, Group A Streptococcal Infection
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 3
MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013)
Non-small Cell Lung Cancer
Not yet recruitingPhase 1/2
cfMSC Stem Cell Therapy Targeting COPD
Chronic Obstructive Pulmonary Disease (COPD)
Active, not recruitingObservational study
A Prospective Study Comparing VivAer to Alternative Surgical Procedures to Treat Nasal Airway Obstruction in Patients With Nasal Valve Dysfunction.
Nasal Airway Obstruction
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.
Patrick Stafler principal investigator
Schneider Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease and Lung Diseases, run by Rabin Medical Center at 1 site in Israel.
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 2 inclusion and 1 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 20 Sep 2021. 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 Israel. 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 Patrick Stafler (00972547243623, pstafler@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cumulative days of hospital admission (time frame: 6 months before compared to 6 months after starting high flow nasal cannula treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2021.