Condition category
Respiratory
Date applied
16/01/2017
Date assigned
26/01/2017
Last edited
26/01/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Respiratory syncytial virus bronchiolitis is a type of chest infection caused by a virus that affects infants, causing small tubes in the lungs to swell. Symptoms include a high temperature (fever), cough and difficulty breathing. Some infants have to be hospitalized in order to be given oxygen through a tube that goes over their nose or face to improve their breathing. Heliox (a mixture of oxygen and helium gases) may be given in order to improve breathing and provide more movement of air through airways that have become smaller due to the infection causing swelling in the lungs. Heliox is normally given using a ventilator which does the job of breathing for the patient through a tube inserted into the mouth. However, there are less invasive methods to provide Heliox such as through a high flow nasal cannula (HFNC) which continuously delivers air through a tube that is inserted into the nostrils. The aim of this study is to evaluate whether Heliox, when delivered through a HFNC, can help improve airflow for infants with bronchiolitis and decrease the need for more complicated therapies.

Who can participate?
Infants who are hospitalized for bronchiolitis

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given the Heliox therapy continuously for 24 hours through a HFNC. Those in the second group are given oxygen continuously for 24 hours through a HFNC. Participants are followed up at the end of the intervention (after 24 hours) to see if there are improvements in the amount of oxygen found in their blood samples and if their breathing improved.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their breathing and it may relieve their symptoms. There is a risk that participants may feel discomfort when providing blood samples.

Where is the study run from?
Al Salam Hospital (Kuwait)

When is the study starting and how long is it expected to run for?
October 2016 to February 2018

Who is funding the study?
Investigator initiated and funded (Kuwait)

Who is the main contact?
Professor Wael Seliem
wseliem@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Wael Seliem

ORCID ID

http://orcid.org/0000-0003-1304-5809

Contact details

Al Salam Hospital
Port Said St.
Bneid Al Qar Dasma
Kuwait
35151
Kuwait
+965 9667 6695
wseliem@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

142281

Study information

Scientific title

Heliox delivered by high flow nasal cannula improves oxygenation in Infants with respiratory syncytial virus acute bronchiolitis

Acronym

Study hypothesis

The aim of the study is to evaluate whether the use of Heliox would result in an improvement of gas exchange when delivered through a high flow nasal cannula continuously (HFNC) in infants with respiratory syncytial virus (RSV) acute bronchiolitis.

Ethics approval

Mansoura University Faculty of Medicine MU, 25/12/2016, ref: 142281/2016

Study design

Single centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Respiratory syncytial virus acute bronchiolitis

Intervention

Participants are randomly allocated to one of four blocks. These blocks are randomly allocated to one of two groups.

Group one (the intervention group) receive Heliox therapy (70:30) delivered through high flow nasal cannula continuously for 24 hours. If the oxygen saturation was kept ≤ 93% despite the fraction of inspired oxygen of 30%, an increment of 5% was done to keep saturation >93%.

Group two (the control group) receive an air-oxygen mixture at 8 L/minute through a high flow nasal cannula continuously for 24 hours. If the oxygen saturation was kept ≤ 93% despite the fraction of inspired oxygen of 30%, an increment of 5% was done to keep saturation >93%.

Participants are followed up at the end of the intervention (24 hours) to see if there is improvement in gas exchange and breathing.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Partial arterial pressure and partial arterial oxygen are assessed using arterial blood samples at baseline, 2 hours and 24 hours
1.1. Oxygen saturation is assessed using pulse Masimo SET pulse oximeter continuously throughout the intervention
2. Respiratory distress is measured by the Modified Wood’s Clinical Asthma Score at 2 hours and 24 hours

Secondary outcome measures

Length of hospital stay is measured by reviewing patient notes at the end of hospital stay.

Overall trial start date

20/10/2016

Overall trial end date

15/02/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants aged from 1 month to 2 years old
2. Patients who are admitted to the pediatric high dependency unit, with RSV acute bronchiolitis diagnosed clinically confirmed by laboratory testing
3. Display the diagnostic criteria of bronchiolitis including cough, tachypnea, chest retraction, prolonged expiratory time, sibilant rhonchi, and hyperinflation of the lungs
3. Cannot maintain oxygen saturation ≥ 93% in room air and require supplemental oxygen on admission to hospital

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. No informed consent obtained
2. Require mechanical ventilation
3. Congenital heart defect that is haemodynamically significant (significant left-to-right shunting with or without pulmonary hypertension or right-to-left shunting)
4. Underlying chronic lung disease including bronchopulmonary dysplasia and previously diagnosed hyper-reactive airway diseases

Recruitment start date

15/02/2017

Recruitment end date

15/11/2017

Locations

Countries of recruitment

Kuwait

Trial participating centre

Al Salam International Hospital
Port Said St Bneid Al Qar Dasma
Kuwait City
35151
Kuwait

Sponsor information

Organisation

Mansoura University Children Hospital

Sponsor details

60 El Gomhoria Street
Mansoura
35516
Egypt

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication

Intention to publish date

15/02/2019

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes