High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".

Study Overview

• Status: Terminated
• Conditions: Bronchiolitis, Viral
• Intervention / Treatment: Device: High flow humidified oxygen therapy

Detailed Description

A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Africa
  • Gauteng
    • Johannesburg, Gauteng, South Africa
      • Chris Hani Baragwanath Academic hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of viral bronchiolitis
• Not requiring intubation and ventilation
• Admitted to high care unit
• With moderate/severe respiratory distress (Tal score >6)
• Saturations <92% in room air

Exclusion Criteria:

• congenital cardiac disease
• presence of multiorgan failure/multisystemic disease
• previously ventilated
• craniofacial abnormalities
• nasal pathology
• decreased level of consciousness
• Ex-prem <34 weeks
• Possible impending respiratory failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: standard therapy group; standard treatment of viral bronchiolitis with low flow oxygen.
EXPERIMENTAL: high flow humidified oxygen group; treatment of viral bronchiolitis with high flow humidified oxygen therapy.	Device: High flow humidified oxygen therapy; application of high flow humidified oxygen therapy at 2l/kg/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of high flow humidified oxygen therapy on work of breathing	Respiratory rate (n/min)	during first 5 days post enrollment
Effect of high flow humidified oxygen therapy on work of breathing	Use of accessory muscles of respiration (present /not)	first 5 days post enrollment
Effect of high flow humidified oxygen therapy on blood oxygen saturations	Saturation of oxygen (% saturation) as measured by pulse oximeter	first 5 days post enrollment
Effect of high flow humidified oxygen therapy on heart rate	Pulse (n/min) measured by ECG monitor	first 5 days post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients requiring intubation and ventilation	number of patients (N) getting intubated	from time of enrollment to end of hospital stay (up to 6 months)
Length of hospital stay	days (N) spent in hospital	from time of enrollment to end of hospital stay (up to 6 months)

Collaborators and Investigators

• Sponsor: Chris Hani Baragwanath Academic Hospital
• Investigators: Principal Investigator: Susan M Murphy, FCPaed (SA), University of the Witwatersrand, Johannesburg

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): August 31, 2018
• Study Completion (ACTUAL): August 31, 2018

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: August 14, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis; Bronchiolitis, Viral
• Other Study ID Numbers: M170234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share data wit other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No