Bronchiolitis of Infancy Discharge Study

ISRCTN	ISRCTN28405428
DOI	https://doi.org/10.1186/ISRCTN28405428
Protocol serial number	HTA 09/91/16, BIDS_1.0
Sponsor	The University of Edinburgh and NHS Lothian (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK) (HTA 09/91/16)

Submission date: 04/03/2011
Registration date: 15/03/2011
Last edited: 21/09/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Bronchiolitis is a common viral lung infection that affects babies and young children under two years old. The majority of infants admitted to hospital with bronchiolitis require supplemental oxygen, but two recent guidelines differ in what experts considered to be the correct blood oxygen level (oxygen saturation) to stop giving supplemental oxygen; one recommended 90% and the other 94%. We aimed to demonstrate that supplemental oxygen does not make any difference to symptoms if stopped at stable 90% oxygen saturation as opposed to the current 94%.

Who can participate?
Infants between 6 weeks and 12 months of age, admitted to hospital with bronchiolitis.

What does the study involve?
Participating infants were randomly allocated to either a standard or a modified monitor to measure their oxygen saturation levels during their hospital stay. Modified monitors displayed a different oxygen saturation level to that measured (within a small range). Clinical outcomes were monitored and parents were followed up to collect information on healthcare and societal costs and parental anxiety levels. Parents completed questionnaires at the start of the study and then by phone after 7 and 14 days and after 6 months to ask about their child’s health and their experience. After 28 days we again met the infants enrolled during the first year of the study to check their oxygen levels and ask about the child’s health.

What are the possible benefits and risks of participating?
Infants in the study had different types of oxygen saturation monitor but no extra tests. Our study investigated whether the use of supplemental oxygen reduces the length of illness or use of healthcare resources once an infant attains satisfactory oral feeding and a stable arterial oxygen saturation of 90% in room air (as opposed to typical 94% in room air). This difference could represent 22 hours longer in hospital.

Where is the study run from?
Five children’s hospitals in Scotland (Aberdeen, Dundee, Edinburgh, Glasgow and Kilmarnock) and three in South West England (Bristol, Exeter and Truro) took part in the study, which was coordinated by the Edinburgh Clinical Trials Unit.

When is the study starting and how long is it expected to run for?
Infants were recruited over two winters (October 2011 – March 2012 and October 2012 – March 2013) to coincide with the busy bronchiolitis season.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Dr Steve Cunningham

Contact information

Dr Steve Cunningham
Scientific

Department of Respiratory and Sleep Medicine
Royal Hospital for Sick Children
Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

ORCID ID	0000-0001-7342-251X

Study information

Primary study design	Interventional
Study design	Multi-centre parallel-group double-blind randomised controlled equivalence study
Secondary study design	Randomised parallel trial
Study type	Participant information sheet
Scientific title	Bronchiolitis of Infancy Discharge Study: a multi-centre, parallel-group, double blind, randomised controlled, equivalence study
Study acronym	BIDS
Study objectives	In infants admitted to hospital with acute viral bronchiolitis, oxygen supplementation does not alter symptom duration or further healthcare use once infants have attained a stable oxygen saturation ≥ 90% in room air. More details can be found at http://www.nets.nihr.ac.uk/projects/hta/099116 Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/54771/PRO-09-91-16.pdf On 16/06/2015 the overall trial end date was changed from 29/03/2013 to 30/10/2013.
Ethics approval(s)	South East Scotland Research Ethics Committee 03, 07/06/2011
Health condition(s) or problem(s) studied	Acute admission with bronchiolitis in infants ≥ 6 weeks and ≤ 12 months of age
Intervention	To test whether acceptance of lower oxygen saturation limits influences recovery from acute bronchiolitis, randomisation will be to a standard or modified pulse oximeter. Standard oximeters will measure and display arterial oxygen saturation (SpO2) as usual care. Modified oximeters will measure arterial oxygen saturation as usual, but manufacturer altered internal algorithms will alter the display to nonstandard; a measured range of SpO2 85-90% will display as a range of SpO2 85-94%.
Intervention type	Other
Primary outcome measure(s)	Time from randomisation to resolution of cough. For this outcome measure, we will be testing for equivalence between the two arms of the trial
Key secondary outcome measure(s)	For these outcome measures, we will be testing for difference between the two arms of the trial 1. Time from randomisation to 1.1. Fit for discharge 1.2. Actual discharge for all infants admitted with acute viral bronchiolitis (ward based data) 2. Proportion of infants with healthcare re-attendance (primary care, emergency department, readmission) (parental phone calls) 3. Change in parental anxiety score between admission and 28 days post admission (home visit questionnaire) 4. Time to return to work/usual activities for parent(s) post admission (parental phone call) 5. Time to return to nursery for infant post admission (parental phone call) 6. Family costs incurred related to time to return to work/nursery (demographic questionnaire and parental phone call) 7. Societal costs for parental return to work (demographic questionnaire and parental phone call) 8. Healthcare costs related to discharge time and subsequent healthcare utilisation (ward based data and parental phone calls) For these outcome measures, we will be testing for equivalence between the two arms of the trial 1. Time from randomisation to re-established feeding (approximately 75% normal) (nursing observation). Accept equivalence of 20% variance, consider as 4 hours based on previous data 2. Time from randomisation to parental perspective of back to normal (feeding, sleeping and asymptomatic) (parental phone call). Accept equivalence of 2 days, based on responses of clinicians to cough resolution times 3. Awake oxygen saturation at 28 days post randomisation (home visit). Accept equivalence of 1.0% SpO2, based on studies demonstrating healthy infant oxygen saturation
Completion date	30/10/2013

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	600
Key inclusion criteria	Infants ≥ 6 weeks and ≤ 12 months of age, admitted to hospital with a clinical diagnosis of bronchiolitis made by a medically qualified practitioner in a emergency department (ED)/AAA
Key exclusion criteria	1. Preterm (< 37 weeks gestation) who received home oxygen therapy in the past 4 weeks 2. Haemodynamically significant congenital heart disease 3. Cystic fibrosis or Interstitial lung disease 4. Documented immune function defect
Date of first enrolment	03/10/2011
Date of final enrolment	29/03/2013

Locations

Countries of recruitment

United Kingdom
England
Scotland

Study participating centres

Royal Hospital for Sick Children

Edinburgh
EH9 1LF
United Kingdom

Royal Aberdeen Children’s Hospital

Westburn Road
Fosterhill
Aberdeen
AB25 2ZG
United Kingdom

Ninewells Hospital and Medical School

Dundee
DD1 9SY
United Kingdom

Royal Hospital for Sick Children

Dalnair Street
Glasgow
G3 8SJ
United Kingdom

Crosshouse Hospital

Kilmarnock Road
Crosshouse
KA2 0BE
United Kingdom

Bristol Children's Hospital

Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Royal Cornwall Hospital

Treliske
Truro
TR1 3LJ
United Kingdom

The Royal Devon and Exeter Hospital

Barrack Road
Wonford
EX2 5DW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2015		Yes	No
Results article	results	12/09/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes