Nasal High Flow Therapy in the Paediatric Home Setting

NCT04037839 | Unknown

• 1 other identifier: Vapotherm
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Disease; Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Change in cumulative days of hospital admission

  For all participants, 2 periods will be compared in terms of days of hospital admissions

  6 months before compared to 6 months after starting high flow nasal cannula treatment

Interventions

Questionnaire OTHER

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.

Eligibility Criteria

• Age: 0 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants and pediatric patients

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Rabin Medical Center: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

RECRUITING

MeSH Terms

Conditions

Respiration Disorders; Lung Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Patrick Stafler

  Schneider Children's

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Stafler

CONTACT

00972547243623; pstafler@hotmail.com

Zvia Dekel

CONTACT

00972523448341; zviade@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Pulmonologist

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 30, 2019
• Study Start: March 26, 2019
• Primary Completion: March 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 20, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)