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

Bronchiolitis, Viral Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03252119
• Other study ID #: M170234
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: July 2019
• Source: Chris Hani Baragwanath Academic Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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".

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis, Viral

Intervention

Device:
• High flow humidified oxygen therapy
application of high flow humidified oxygen therapy at 2l/kg/min

Locations

Country	Name	City	State
South Africa	Chris Hani Baragwanath Academic Hospital	Johannesburg	Gauteng

Sponsors (1)

Lead Sponsor	Collaborator
Chris Hani Baragwanath Academic Hospital

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of high flow humidified oxygen therapy on work of breathing	Respiratory rate (n/min)	during first 5 days post enrollment
Primary	Effect of high flow humidified oxygen therapy on work of breathing	Use of accessory muscles of respiration (present /not)	first 5 days post enrollment
Primary	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
Primary	Effect of high flow humidified oxygen therapy on heart rate	Pulse (n/min) measured by ECG monitor	first 5 days post enrollment
Secondary	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)
Secondary	Length of hospital stay	days (N) spent in hospital	from time of enrollment to end of hospital stay (up to 6 months)