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Trial registered on ANZCTR


Registration number
ACTRN12620000616976
Ethics application status
Approved
Date submitted
4/05/2020
Date registered
27/05/2020
Date last updated
27/05/2020
Date data sharing statement initially provided
27/05/2020
Date results information initially provided
27/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A comparison of two nasogastric feeding methods in infants with bronchiolitis: a randomised controlled trial (BANG Trial)
Scientific title
A randomised clinical trial comparing the effect of two nasogastric feeding methods on length of stay in infants with bronchiolitis.
Secondary ID [1] 301185 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
BANG Trial (Bronchiolitis and nasogastric feeding: a randomised controlled trial)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 317334 0
Condition category
Condition code
Respiratory 315442 315442 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infants less than 12 months who are admitted with bronchiolitis and require supplemental nasogastric fluids will be randomised to bolus nasogastric feeding compared to continuous nasogastric feeds. Both are currently clinically acceptable interventions.
Group A will be commenced on bolus 2-3 hourly nasogastric feeds at a rate and volume according to the patient's weight as outlined in the Children's Health Queensland (CHQ) Guideline and the Australasian PREDICT Bronchiolitis Guideline. Patients will be stratified into two groups based on age. These groups will be 0-5 months and 6-12 months of age. Their treating team can progress to oral feeding when deemed clinically appropriate. Patients severely unwell and admitted directly to the paediatric intensive care unit (PICU) will be stratified separately. Consent is gained by the General Paediatric treating team upon clinical requirement of nasogastric supplementation. The treating team, nursing staff, and research team oversaw adherence to the intervention unless a paediatrician or paediatric intensivist deemed it clinically necessary to convert to continuous feeds or intravenous therapy. The patient's nasogastric tube was labelled with the allocated intervention.
Intervention code [1] 317495 0
Treatment: Other
Comparator / control treatment
Group B will be commenced on continuous nasogastric feeds at a rate and volume according to the patient's weight as outlined in the Children's Health Queensland (CHQ) Guideline and the Australasian PREDICT Bronchiolitis Guideline. Patients will be stratified into two groups based on age. These groups will be 0-5 months and 6-12 months of age. Their treating team can progress to bolus nasogastric or oral feeding when deemed clinically appropriate. Patients severely unwell and admitted directly to the paediatric intensive care unit (PICU) will be stratified separately. Consent is gained by the General Paediatric treating team upon clinical requirement of nasogastric supplementation. The treating team, nursing staff, and research team oversaw adherence to the intervention unless a paediatrician or paediatric intensivist deemed it clinically necessary to convert to intravenous therapy. The patient's nasogastric tube was labelled with the allocated intervention.
Control group
Active

Outcomes
Primary outcome [1] 323692 0
Length of stay measured as the difference between admission time and the time the child is ready for discharge. An infant will be considered ready for discharge if he/she has not received supplemental oxygen for 12 hours, has had stable respiratory status for 4 hours (including slight or nil recession) and is feeding adequately. This is all determined from hospital electronic records.
Timepoint [1] 323692 0
Discharge from hospital.
Secondary outcome [1] 382609 0
Number of paediatric intensive care admissions as per hospital electronic records.
Timepoint [1] 382609 0
At paediatric intensive care admission.
Secondary outcome [2] 382999 0
Composite secondary outcome of number of pulmonary aspiration events.

A pulmonary aspiration event is defined as an acute deterioration in respiratory status associated with the clinical concern for aspiration (by the clinical treating team contacting the principal investigator of this trial OR determined from hospital electronic records) AND an associated increase in supplemental oxygen provision (determined from hospital electronic records) AND chest radiograph changes consistent with aspiration as reported by a radiologist blinded to the child’s clinical group (determined from hospital electronic records).



Timepoint [2] 382999 0
Occurrence of clinical concern for pulmonary aspiration.

Eligibility
Key inclusion criteria
Inclusion Criteria
• Infants less than 12 months corrected age
• Clinical diagnosis of bronchiolitis
• Requiring nasogastric feeding
• Parents / guardian read and understand English
Minimum age
No limit
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria
• Neurological disease with impairment of tone/swallowing/feeding
• Already receiving nasogastric or gastrostomy feeding prior to admission
• Any contraindication to insertion of nasogastric tube e.g. choanal atresia
• Inability to insert nasogastric tube

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by computer generated block randomisation, generated and packed into opaque, sealed envelopes by an independent person. Patients will be stratified into two groups based on age. These groups will be 0 - 5 months and 6 – 12 months of age. Additional patients recruited by direct admission to Intensive Care will be stratified (due to severity) in a different group to those recruited directly to the general paediatric ward.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Sample size and statistical power
In a study performed by the PREDICT group “Nasogastric hydration versus intravenous hydration for infants with bronchiolitis: a randomised control trial” the mean (+/-SD) length of stay in bronchiolitis was 85 hours (+/-58 hours). Based on this data, in order to demonstrate a difference in length of stay of one day (24 hours) in the bolus group, the recruitment of 93 participants per arm was estimated to achieve a power of 80% at a significance level of 5% (using a two sided independent t-test). To account for potential drop-out, estimated around 5%, a minimum of 100 participants in each arm will be needed, thus 200 participants required in total.
For a comparison to patients severely unwell and directly admitted to paediatric intensive care rather than the general paediatric ward, up to 50 further participants will be recruited directly from intensive care.

Data analysis plan
To assess the efficacy of bolus feeding compared to continuous nasogastric feeding for length of stay, the groups will be compared using a parametric two-sample t-test (if data is normally distributed) or non-parametric Mann-Whitney test (if assumption of normality is not met). Normality will be tested using Shapiro-Wilk test. Regression modelling risk analysis will be performed on collected data in an attempt to identify risk factors for increasing length of stay.
The rate of pulmonary aspiration or intensive care admission will be computed in both groups and compared using Chi-square or Fisher’s exact test when appropriate.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16602 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 30199 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 305635 0
Hospital
Name [1] 305635 0
Children's Health Queensland.
Address [1] 305635 0
Queensland Children's Hospital
501 Stanley Street,
South Brisbane, Queensland 4101
Country [1] 305635 0
Australia
Primary sponsor type
Individual
Name
Dr Alyssa Courtney
Address
Queensland Children's Hospital
501 Stanley Street,
South Brisbane, Queensland 4101
Country
Australia
Secondary sponsor category [1] 306171 0
Individual
Name [1] 306171 0
Professor Peter Sly
Address [1] 306171 0
L7 Centre for Children's Health Research
62 Graham Street,
South Brisbane, Queensland 4101
Country [1] 306171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305923 0
Children's Health Queensland Hospital and Health Service Human Ethics Research Committee
Ethics committee address [1] 305923 0
Level 7, Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 305923 0
Australia
Date submitted for ethics approval [1] 305923 0
29/04/2015
Approval date [1] 305923 0
11/06/2015
Ethics approval number [1] 305923 0
HREC/15/QRCH/8

Summary
Brief summary
Viral bronchiolitis is the most common cause of hospital admission in infants. Annually at the Queensland Children's Hospital approximately 500 infants are admitted overnight. It is common for infants with moderate to severe respiratory distress to be commenced on continuous nasogastric feeds. This is based on an anecdotal hypothesis that it will reduce the risk of pulmonary aspiration and decrease splinting of the diaphragm which reduces respiratory effort. No published evidence could be found to support this. The process of upgrading from continuous to bolus to oral feeds can take 24-72 hours, likely prolonging admission and contributing to the burden of bronchiolitis on families and the health system. The aim of this study is to establish whether continuous nasogastric feeding prolongs hospital length of stay in infants admitted with a clinical diagnosis of bronchiolitis. The inter-departmental study also aims to establish that bolus nasogastric feeding in bronchiolitis is not associated with the adverse outcome of aspiration or paediatric intensive care admission.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102078 0
Dr Alyssa Courtney
Address 102078 0
Queensland Children's Hospital
501 Stanley Street,
South Brisbane, Queensland 4101
Country 102078 0
Australia
Phone 102078 0
+61 7 3068 1111
Fax 102078 0
Email 102078 0
alyssa.courtney@health.qld.gov.au
Contact person for public queries
Name 102079 0
Dr Alyssa Courtney
Address 102079 0
Queensland Children's Hospital
501 Stanley Street,
South Brisbane, Queensland 4101
Country 102079 0
Australia
Phone 102079 0
+61 7 3068 1111
Fax 102079 0
Email 102079 0
alyssa.courtney@health.qld.gov.au
Contact person for scientific queries
Name 102080 0
Dr Alyssa Courtney
Address 102080 0
Queensland Children's Hospital
501 Stanley Street,
South Brisbane, Queensland 4101
Country 102080 0
Australia
Phone 102080 0
+61 7 3068 1111
Fax 102080 0
Email 102080 0
alyssa.courtney@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 7854 0
Study protocol
Citation [1] 7854 0
Link [1] 7854 0
Email [1] 7854 0
alyssa.courtney@health.qld.gov.au
Other [1] 7854 0
Attachment [1] 7854 0
Type [2] 7855 0
Ethical approval
Citation [2] 7855 0
Link [2] 7855 0
Email [2] 7855 0
Other [2] 7855 0
Type [3] 7856 0
Informed consent form
Citation [3] 7856 0
Link [3] 7856 0
Email [3] 7856 0
Other [3] 7856 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary