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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

13/09/2021

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]

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

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

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]

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]

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]

Throughout the duration of the trial period

The trial will run for 2 months in total.

Primary outcome [2]

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]

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]

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]

Secondary outcome [1]

• The tolerability of nasogastric fluids

This will be assessed by a study specific questionnaire

Timepoint [1]

Secondary outcome [2]

• 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]

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]

• 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]

after nasogastric fluids are initially ceased and during the patients time in hospital

Secondary outcome [4]

• 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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

7/01/2020

Actual

20/01/2020

Date of last participant enrolment

Anticipated

15/03/2020

Actual

20/12/2020

Date of last data collection

Anticipated

15/03/2020

Actual

20/12/2020

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Gold Coast University Hospital - Southport

Recruitment postcode(s) [1]

4215 - Southport

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Gold Coast University Hospital- The Paediatric Critical Care Research Group

Address [1]

Gold Coast University Hospital, 1 Hospital Boulevard, Southport, QLD, 4215, Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Gold Coast University Hospital

Address

1 Hospital Boulevard, Southport, QLD, 4215, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Gold Coast Hospital and Health Service Ethics Committee

Ethics committee address [1]

Office for Research Governance and Development Level 2, Pathology and Education Building 
1 Hospital Boulevard, Southport, QLD, 4215

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/11/2019

Approval date [1]

14/11/2019

Ethics approval number [1]

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

Dr Ravichandra Balakrishnamoorthy

Address

Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia

Country

Australia

Phone

+61 7 5687 1236

Fax

[email protected]

Contact person for public queries

Name

Ravichandra Balakrishnamoorthy

Address

Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia

Country

Australia

Phone

+61 7 5687 1236

Fax

[email protected]

Contact person for scientific queries

Name

Ravichandra Balakrishnamoorthy

Address

Gold Coast University Hospital Children’s Inpatient Unit
1 Hospital Boulevard, Southport, QLD 4215, Australia

Country

Australia

Phone

+61 7 5687 1236

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
5966	Study protocol	378848-(Uploaded-18-01-2020-11-57-08)-Study-related document.pdf
5967	Informed consent form	378848-(Uploaded-30-11-2019-19-57-55)-Study-related document.docx
5968	Ethical approval	378848-(Uploaded-30-11-2019-19-58-25)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically