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Trial registered on ANZCTR


Registration number
ACTRN12624000854538
Ethics application status
Approved
Date submitted
8/05/2024
Date registered
10/07/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
10/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A single-group pilot trial evaluating the effect of pre-procedural chewables on gastric volume and ease of fasting in children undergoing surgery (JELLYFISH - Phase One)
Scientific title
A single-group pilot trial evaluating the effect of pre-procedural chewables on gastric volume and ease of fasting in children undergoing surgery (JELLYFISH - Phase One)
Secondary ID [1] 311886 0
NIL
Universal Trial Number (UTN)
Trial acronym
JELLYFISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pre-operative fasting 333462 0
Condition category
Condition code
Anaesthesiology 330133 330133 0 0
Anaesthetics
Alternative and Complementary Medicine 330134 330134 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre, open-label, clinical trial at Perth Children’s Hospital to evaluate efficacy of pre-procedural chewables for use in pre-procedural fasting.

In this trial we will investigate pre-procedural carbohydrate-based chewables, which comes in two flavours. One chewable is prepared using a blueberry-flavoured simple syrup and the other uses a vanilla-flavoured maple syrup.

The pre-procedural chewables are carbohydrate-rich solid chewables (1 x 1 x 0.5cm) which dissolve quickly and completely. The design principle was that of a “solid to clear liquid formulation in vivo” to comply with the anaesthetic fasting guidelines. The chewables are formulated to have the following properties:
- Rapid and complete dissolution in the mouth to become a clear liquid within 3 minutes
- Does not precipitate into particulate material in the acidic content of the stomach
- Safe to administer to young children
- Taste and texture that is acceptable to young children.
- Physically stable for transport and storage at ambient conditions

The ingredients in the pre-procedural chewables are food ingredients purchased from registered Australian suppliers. Further information cannot be supplied at this stage for confidentiality reasons.

The chewables will be manufactured in the WA Hospitals Central Pharmaceutical Manufacturing Facility (Auspman). The chewables will adhere to acceptable pharmaceutical standards and the quality of the chewables will be confirmed through various tests, including batch reproducibility, dissolution time in simulated saliva, precipitation in simulated gastric, mechanical integrity during storage and transport, texture and appearance. Auspman is located in Balcatta, WA and is the manufacturing arm of the Pharmacy Department at Perth Children’s Hospital.

This is the first phase of a two-phase trial. This phase will evaluate the efficacy of the tablets in children undergoing upper gastrointestinal endoscopic examination.

This phase will involve recruiting 20 patients scheduled for an upper gastrointestinal endoscopy. All children will be offered 20 pre-procedural chewables a maximum of four hours prior to the scheduled procedure time. Participants can consume as many of these chewables as they like until one hour prior to the scheduled procedure time. The total volume for 20 of the pre-procedural chewables is approximately 9mls. This quantity is well below the permitted 3mls/kg of clear fluid allowed at 1hr prior to surgery. Aside from the pre-procedural chewables, participants will be fasted in line with current Perth Children’s Hospital institutional guidelines. Participants will be allowed to consume 3 mLs/kg per hour clear liquid (water, apple juice or lemonade) until one hour prior to surgery.

The gastroenterologist performing the procedure will visually assess the presence/absence of the pre-procedural chewables in the stomach during the procedure. Furthermore, the amount of gastric volume will be assessed through suctioning of stomach contents at the start of the procedure. Participants will be assessed post-operatively for the incidence of any post-operative nausea and vomiting. Parents/guardians of participants will receive a link to a short follow-up survey 24-48 hours after their procedure asking them to appraise their ease of fasting, and whether they think the intervention helped them with fasting.

Parents will be asked how many chewables their child consumes.In order to adequately assess the in-vivo dissolution of the pre-procedural chewables any child who has not eaten all 20 chewables will be replaced until 20 participants are recruited who have consumed 20 chewables.
Intervention code [1] 328352 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337888 0
Assess the in-vivo dissolution of the fasting pre-procedural chewables in children undergoing upper gastrointestinal endoscopies.
Timepoint [1] 337888 0
Assessed during the endoscopy.
Primary outcome [2] 337891 0
Assess the impact of the pre-procedural chewables on gastric volume.
Timepoint [2] 337891 0
Suctioning will occur at the start of the endoscopy.
Primary outcome [3] 337892 0
Acceptance of the fasting chewables of fasting children
Timepoint [3] 337892 0
Children will be asked post-operatively on the day of surgery.
Secondary outcome [1] 433607 0
Assess the acceptance of the fasting chewables to parents of fasting children scheduled for surgery.
Timepoint [1] 433607 0
Parents will be asked post-operatively on the day of surgery.
Secondary outcome [2] 433608 0
Assessment of post-operative nausea and vomiting (PONV) in children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
Timepoint [2] 433608 0
Assessed in the first 6 hours after their procedure or until discharge from hospital.
Secondary outcome [3] 435926 0
Assessment of the ease of fasting in children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
Timepoint [3] 435926 0
Participants will be emailled a survey to be completed 24-48 hours post-procedure.
Secondary outcome [4] 435929 0
Assessment of the ease of fasting in parents of children undergoing upper gastrointestinal endoscopy who have been given the pre-procedural chewables.
Timepoint [4] 435929 0
Participants will be emailled a survey to be completed 24-48 hours post-procedure.
Secondary outcome [5] 435931 0
Assessment of how much participants liked the chewables
Timepoint [5] 435931 0
Participants will be asked post-operatively on the day of surgery.
Secondary outcome [6] 435932 0
Assessment of how hungry and thirsty participants felt prior to their surgery
Timepoint [6] 435932 0
Participants will be asked post-operatively on the day of surgery.
Secondary outcome [7] 435933 0
Assessment of participant's fasting discomfort.
Timepoint [7] 435933 0
Participants will be asked post-operatively on the day of surgery.

Eligibility
Key inclusion criteria
Phase One; Children aged 3 to 16 years undergoing electic upper gastrointestinal endoscopy
Minimum age
3 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Phase One:
• Known allergy to ingredients of pre-procedural chewables
• Children with diabetes
• Patients undergoing urgent procedures (gastrointestinal bleeding, oesophageal foreign body)
• Patients with known or suspected delayed gastric emptying.
• Children undergoing colonoscopy in addition to endoscopy
• Children with pre-existing gastro-oesophageal reflux

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Data will be monitored for fidelity as the trial progresses. Statistical analysis will be performed in the R statistical environment (http://www.Rproject.org). Continuous data will be summarized using the mean (SD), or median (interquartile range) if skewed, and categorical data using counts (%). Significance will be assessed at p<0.05.

Phase One
The primary outcome is the presence/absence of residue from the chewable tables in the stomach (binary: yes/no). The numbers of participants with chewable residue present in the stomach will be reported.

Secondary outcome variables for this phase will be summarised in each group.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
24/09/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/10/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26520 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 42561 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 316234 0
Hospital
Name [1] 316234 0
Perth Children's Hospital
Country [1] 316234 0
Australia
Funding source category [2] 316461 0
Charities/Societies/Foundations
Name [2] 316461 0
Telethon Trust
Country [2] 316461 0
Australia
Funding source category [3] 316462 0
Government body
Name [3] 316462 0
WA Department of Health
Country [3] 316462 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Kids Research Institute Australia
Address
Country
Australia
Secondary sponsor category [1] 318424 0
None
Name [1] 318424 0
Address [1] 318424 0
Country [1] 318424 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315057 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315057 0
15 Hospital Avenue Nedlands Western Australia 6009
Ethics committee country [1] 315057 0
Australia
Date submitted for ethics approval [1] 315057 0
26/02/2024
Approval date [1] 315057 0
03/05/2024
Ethics approval number [1] 315057 0
RGS0000006727

Summary
Brief summary
Pre-operative fasting is an important part of preparing for anaesthesia. Fasting reduces the volume and acidity of the stomach contents, which serves to reduce the risk of regurgitation and pulmonary aspiration. Fasting can be particularly stressful for young children, which can in turn lead to negative psychosocial and physiological outcomes. In this study, we wish to investigate if a pre-procedural carbohydrate-based chewables can help children to better tolerate pre-operative fasting.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133530 0
Prof Britta von Ungern-Sternberg
Address 133530 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 133530 0
Australia
Phone 133530 0
+61 420790101
Fax 133530 0
Email 133530 0
[email protected]
Contact person for public queries
Name 133531 0
Britta von Ungern-Sternberg
Address 133531 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 133531 0
Australia
Phone 133531 0
+61 420790101
Fax 133531 0
Email 133531 0
[email protected]
Contact person for scientific queries
Name 133532 0
Britta von Ungern-Sternberg
Address 133532 0
Perth Children's Hospital 15 Hospital Avenue Nedlands WA 6009
Country 133532 0
Australia
Phone 133532 0
+61 420790101
Fax 133532 0
Email 133532 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Investigators for the study are still deciding upon how to proceed with this and are awaiting feedback from their HREC.


What supporting documents are/will be available?

No Supporting Document Provided



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.