Clinical trial NCT04037839: Nasal High Flow Therapy in the Paediatric Home Setting
Official title: High Flow Nasal Cannula Therapy in the Paediatric Home Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Disease
Lung Diseases
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Fisher and Paykel Healthcare
First posted: 2019-07-30
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants and pediatric patients

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in cumulative days of hospital admission
timeFrame: 6 months before compared to 6 months after starting high flow nasal cannula treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Schneider Children's
name: Patrick Stafler
role: PRINCIPAL_INVESTIGATOR
References: