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Trial registered on ANZCTR


Registration number
ACTRN12619001789156
Ethics application status
Approved
Date submitted
30/11/2019
Date registered
19/12/2019
Date last updated
11/02/2020
Date data sharing statement initially provided
19/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Pilot Feasibility Trial of Nasogastric fluid Options in BROnchiolitis: The NOBRO study
Scientific title
A Pilot Feasibility Trial of Nasogastric fluid Options in BROnchiolitis: The NOBRO study
Secondary ID [1] 299968 0
none
Universal Trial Number (UTN)
U1111-1244-7680
Trial acronym
The NOBRO Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis
315426 0
Condition category
Condition code
Respiratory 313725 313725 0 0
Other respiratory disorders / diseases
Infection 313948 313948 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intermittent Bolus Nasogastric Fluids.

Bronchiolitis is a viral infection that affects the lungs and respiratory tract in children less than 12 months of age. It is the leading cause of hospital admission during the first year of life. Patients with bronchiolitis often work harder to breathe and as a result can have trouble feeding effectively, and are therefore at risk of dehydration, which can lead to a longer length of stay in hospital. Approximately a third of patients with bronchiolitis require fluid replacement.

For patients with bronchiolitis who cannot maintain hydration orally, fluid replacement can be accomplished by nasogastric fluids (fluids delivered through a tube which goes through the patients nose directly into the patients’ stomach).

There are two Nasogastric fluid hydration regimes used; intermittent bolus fluids (when a patient has the same volume delivered through the nasogastric tube over a 1-hour period that they would typically have in a normal oral feed) or continuous fluids (when a patient has the same bolus fluid amount delivered through the nasogastric tube, however given at a slow continuous rate).

There is no consensus as to which nasogastric fluid regime should be prescribed for patients with bronchiolitis.

In our trial, patients with bronchiolitis that require nasogastric fluids will be consented by a trial research assistant, and randomised to receive either intermittent bolus (3- hourly), or continuous nasogastric fluids.

The precise amount of fluid administered to patients on the trial is calculated based on the patients age and weight using the below formula as per the Australasian PREDICT Bronchiolitis guideline for calculating a patients Total Fluid Requirement (TFR):
-->0-3 months -150ml/kg/day
-->3-6 months -120ml/kg/day
-->6-12 months - 100ml/kg/day

As per clinical recommendations from the Australasian Bronchiolitis Guideline, all patients on the trial will be prescribed 2/3 (67%) of their TFR

For patients receiving intermittent bolus fluids, their TFR is divided by 8 to give them a 3- hourly fluid quota. For patients receiving continuous fluids, their TFR is divided by 24 to give them their hourly fluid rate.

The nasogastric fluid used will be either
-->expressed breast milk- for babies that are normally breast-fed or normally given expressed breast milk bottles
-->formula milk- for babies that are normally fed formula milk
-->Oral Rehydration Solution (such as Hydralyte or Gastrolyte)- for babies that are normally breastfed, but are not able to express breast milk

The allocated nasogastric fluid regime will then be prescribed by the patients treating doctor and administered by the patients treating nurse. Their nasogastric fluid regime will continue until the patient has achieved adequate oral feeding. The patient's nasogastric fluids can be discontinued when the patient has tolerated adequate oral feeding (which we have defined as 2 tolerated oral feeds of at least 50% of the patients pre-morbid oral feeding quota).

A dedicated NOBRO trial research nurse will monitor adherence to study protocols and collect data outcomes.
Intervention code [1] 316232 0
Treatment: Other
Comparator / control treatment
Continuous nasogastric fluids

In our trial, patients with bronchiolitis that require nasogastric fluids will be consented by a trial research assistant, and randomised by their treating nurse to receive either intermittent bolus, or continuous nasogastric fluids. The allocated nasogastric fluid regime will then be commenced.

The precise amount of fluid administered to patients on the trial is calculated based on the patients age and weight using the below formula as per the Australasian PREDICT Bronchiolitis guideline for calculating a patients Total Fluid Requirement (TFR):
-->0-3 months -150ml/kg/day
-->3-6 months -120ml/kg/day
-->6-12 months - 100ml/kg/day

As per clinical recommendations from the Australasian Bronchiolitis Guideline, all patients on the trial will be prescribed 2/3 (67%) of their TFR

continuous fluids refers to when a patient is given the same amount of TFR per day, but rather than achieving this volume by feeding every 3 hours, the fluid is given as a slow continuous rate over 24 hours. For patients receiving continuous fluids, their TFR is divided by 24 to give them their hourly fluid rate

Their nasogastric fluid regime can be discontinued when the patient has tolerated adequate oral feeding (which we have defined as >2 tolerated oral feeds of at least 50% of the patients pre-morbid oral feeding quota).
Control group
Active

Outcomes
Primary outcome [1] 322147 0
Feasibility of the trial

This will be assessed by our recruitment and retention rates which will be gathered via study and patient records
Timepoint [1] 322147 0
Throughout the duration of the trial period

The trial will run for 2 months in total.
Primary outcome [2] 322347 0
the Time taken to return to Adequate Oral Feeding (TAOF)

This will be assessed by
-->accessing the patients' medical records for the time period that the patient is enrolled on the trial.
-->a study specific questionnaire
Timepoint [2] 322347 0
The study specific questionnaire is administered at the time of starting nasogastric fluids and completed by our research nurse throughout the duration the patient is receiving nasogastric fluids. Study specific questionnaires will be followed up over the duration of the trial period (2 months in total)
Primary outcome [3] 322348 0
The completeness of data reporting

This will be assessed by accessing patient records and a study specific questionnaire to perform an audit on the completeness of data reporting.
Timepoint [3] 322348 0
The study specific questionnaire is administered at the time of starting nasogastric fluids and completed by our research nurse throughout the duration the patient is receiving nasogastric fluids. Study specific questionnaires will be followed up over the duration of the trial period (2 months in total)
Secondary outcome [1] 377486 0
• The tolerability of nasogastric fluids

This will be assessed by a study specific questionnaire
Timepoint [1] 377486 0
The study specific questionnaire is administered at the time of starting nasogastric fluids and completed by our research nurse throughout the duration the patient is receiving nasogastric fluids. Study specific questionnaires will be followed up over the duration of the trial period (2 months in total)
Secondary outcome [2] 377487 0
• Length of hospital stay

This will be assessed by both
-->accessing the patients' medical records for the time period that the patient is enrolled on the trial.
-->study specific questionnaire
Timepoint [2] 377487 0
The length of the patients' hospital stay will be determined by accessing the patients medical record for the time period the patient is enrolled on the trial.

The study specific questionnaire is administered at the time of starting nasogastric fluids and completed by our research nurse throughout the duration the patient is receiving nasogastric fluids. Study specific questionnaires will be followed up over the duration of the trial period (2 months in total)
Secondary outcome [3] 377488 0
• The number of infants requiring re-instatement of nasogastric fluids after nasogastric fluids are initially ceased

This will be assessed by accessing the patients' medical records for the time period that the patient is enrolled on the trial.
Timepoint [3] 377488 0
after nasogastric fluids are initially ceased and during the patients time in hospital
Secondary outcome [4] 377489 0
• Adverse events, including:
o Persistent vomiting
o Pulmonary aspiration events

This will be assessed by both
-->accessing the patients' medical records for the time period that the patient is enrolled on the trial.
-->a study specific questionnaire
Timepoint [4] 377489 0
The study specific questionnaire is administered at the time of starting nasogastric fluids and completed by our research nurse throughout the duration the patient is receiving nasogastric fluids. Study specific questionnaires will be followed up over the duration of the trial period (2 months in total)

Eligibility
Key inclusion criteria
• Inclusion criteria
o Patient under 12 months (and 0 days) chronological age
o Patient diagnosed with bronchiolitis (regardless of the severity) as their primary diagnosis for hospital admission
o Patient deemed by their treating clinician to require nasogastric fluids due to poor oral feeding
Minimum age
0 Days
Maximum age
12 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Nasogastric tube, or other gastric feeding device in situ already in situ for normal feeds in the pre-morbid state
2. Requiring > 2L/kg of Highflow oxygen at the time of initiating nasogastric fluids
3. Receiving non invasive mask ventilation (CPAP or BIPAP) at the time of initiating nasogastric fluids
4. Intubated and requiring mechanical ventilation at the time of initiating nasogastric fluids
High clinical suspicion of the need for escalated respiratory support (ie. Above 2L/kg of highflow oxygen) within the next 24 hours
5. Patients transferred to Gold Coast University Hospital from a peripheral hospital, or with a plan for backtransfer to a peripheral hospital

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)
If consent is received, the patient will then be randomised to receive their nasogastric fluids at either a continuous rate or via intermittent boluses.

A block randomization strategy will be employed using statistical software Stata 15. Randomizations will be provided in consecutively numbered opaque sealed envelopes.

Due to the nature of the interventions assigned to each group, blinding of participants and the research assistant is not feasible. However, once outcome data is collected and recorded by the research assistant, the final data set will be further coded in such a way as to deidentify which nasogastric fluid regime patients were assigned to, further ensuring that the statistician analysing the results is blinded to the patients allocation .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software

A block randomization strategy will be employed using the ralloc command of the statistical software Stata 15.

Participants will be sampled consecutively
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We plan to conduct a randomised controlled trial (RCT) to help inform our hypothesis on which nasogastric fluids result in a quicker time to adequate oral feeding.

Prior to this however, we will conduct a pilot RCT, in order to test and refine the study procedures prior to beginning the main trial and to identify what might be considered a clinically important difference in our primary outcome measure and its standard deviation. This will enable reliable power calculations for the proposed RCT. The primary outcome measure is a specifically defined measure of time taken for the patient to return to adequate oral feeding. As this is not a routine or well published measure, our pilot will enable a greater understanding of it and enable assessment of its appropriateness prior to the RCT. Other feasibility related factors will also be addressed such as recruitment and retention rates, possible problems in the randomisation process, and adherence to the randomised protocol.

Recruitment
Recruitment status
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] 15360 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 28675 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 304428 0
Hospital
Name [1] 304428 0
Gold Coast University Hospital-Study, Education and Research Trust Account (SERTA) funding scheme
Address [1] 304428 0
Gold Coast University Hospital, 1 Hospital Boulevard, Southport, QLD, 4215, Australia
Country [1] 304428 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital
Address
1 Hospital Boulevard, Southport, QLD, 4215, Australia
Country
Australia
Secondary sponsor category [1] 304686 0
None
Name [1] 304686 0
N/A
Address [1] 304686 0
N/A
Country [1] 304686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304864 0
Gold Coast Hospital and Health Service Ethics Committee
Ethics committee address [1] 304864 0
Office for Research Governance and Development Level 2, Pathology and Education Building
1 Hospital Boulevard, Southport, QLD, 4215
Ethics committee country [1] 304864 0
Australia
Date submitted for ethics approval [1] 304864 0
01/11/2019
Approval date [1] 304864 0
14/11/2019
Ethics approval number [1] 304864 0
HREC/2019/QGC/57017

Summary
Brief summary
There is no consensus as to which nasogastric fluid regime (continuous or intermittent-bolus fluids) should be prescribed for patients with bronchiolitis who cannot maintain oral hydration.

We will perform a randomised controlled trial (RCT) in the future comparing intermittent bolus and continuous nasogastric fluids for patients with bronchiolitis that require nasogastric fluids, with the aim of determining which fluid regime leads to a quicker return to normal oral feeding.

Prior to this, we will conduct a pilot RCT, in order to test and refine the study procedures prior to beginning the main trial and to identify the feasibility, power calculation and sample size for the main trial. This pilot study is the one currently being conducted, not the main RCT.

The main RCT will occur in the future after the results of this current pilot study are analysed and reported.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 98450 0
Dr Ravichandra Balakrishnamoorthy
Address 98450 0
Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia
Country 98450 0
Australia
Phone 98450 0
+61 7 5687 1236
Fax 98450 0
Email 98450 0
ravi.bala@health.qld.gov.au
Contact person for public queries
Name 98451 0
Dr Ravichandra Balakrishnamoorthy
Address 98451 0
Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia
Country 98451 0
Australia
Phone 98451 0
+61 7 5687 1236
Fax 98451 0
Email 98451 0
ravi.bala@health.qld.gov.au
Contact person for scientific queries
Name 98452 0
Dr Ravichandra Balakrishnamoorthy
Address 98452 0
Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia
Country 98452 0
Australia
Phone 98452 0
+61 7 5687 1236
Fax 98452 0
Email 98452 0
ravi.bala@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] 5966 0
Study protocol
Citation [1] 5966 0
Link [1] 5966 0
Email [1] 5966 0
Other [1] 5966 0
Type [2] 5967 0
Informed consent form
Citation [2] 5967 0
Link [2] 5967 0
Email [2] 5967 0
Other [2] 5967 0
Type [3] 5968 0
Ethical approval
Citation [3] 5968 0
Link [3] 5968 0
Email [3] 5968 0
Other [3] 5968 0
Summary results
No Results