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Trial registered on ANZCTR


Registration number
ACTRN12617001504303
Ethics application status
Approved
Date submitted
16/10/2017
Date registered
25/10/2017
Date last updated
5/09/2019
Date data sharing statement initially provided
5/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Tympanometry in the Emergency Management of Children with Acute Otitis Media
Scientific title
Efficacy of Tympanometry in the Emergency Management of Children with Acute Otitis Media
Secondary ID [1] 293136 0
Nil known
Universal Trial Number (UTN)
Trial acronym
AOM (Acute Otitis Media)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Otitis Media 305106 0
Condition category
Condition code
Ear 304418 304418 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children presenting the the Caboolture Hospital Emergency Department with Acute Otitis Media will be randomly assigned to either of two groups, the standard care group or the standard care plus tympanometry group.

The standard care group will undergo triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute onset of signs and symptoms (<48 hrs), signs of middle ear inflammation and middle ear effusion. Management usually involves analgesia and either a 'watch and wait' approach to see if symptoms resolve spontaneously, or antibiotic prescription if the child has systemic features (high fever >39 degrees celsius, vomiting, lethargy). Antibiotics may also be required if:
Age <2 years with bilateral AOM
Symptoms persisting past 48 hours
Severe symptoms (fever>39 degrees celsisus, moderate to severe otalgia)
Evidence of perforation
higher risk of complications (mastoiditis, chronic suppurative otitis media), immunodeficiency, uncertain access to follow up.

Participants allocated to the standard care plus tympanometry group (intervention group) will have tympanometry, an objective test of middle ear function, performed in addition to the standard care assessments in the emergency department once triaged. Tympanometry varies air pressure inside the External ear canal from +100 daPa to -300 daPa and records the effect on tympanic membrane mobility. It has clinical validity in identifying normal vs abnormal middle ear function and will be performed on each participant in the tympanometry group by a registered clinical Audiologist with over 15 years experience. It is expected it will only need to be performed once per ear to obtain accurate results.

The aim of this study is to determine if providing tympanometry can improve diagnosis and subsequent management of Acute Otitis Media in young children.
Intervention code [1] 299386 0
Diagnosis / Prognosis
Intervention code [2] 299450 0
Treatment: Other
Comparator / control treatment
Children not assigned to the tympanometry group will receive the standard care processes usually provided to children with Acute Otitis Media at the Caboolture Hospital Emergency Department.

The standard care process involves triage, assessment and treatment as per the Queensland Health guidelines for the care and management of children with otitis media (document ID: CHQ-GDL-00710). This involves determining a clinical diagnosis of Acute Otitis Media based on acute onset of signs and symptoms (<48 hrs), signs of middle ear inflammation and middle ear effusion. Management usually involves analgesia and either a 'watch and wait' approach to see if symptoms resolve spontaneously, or antibiotic prescription if the child has systemic features (high fever >39 degrees celsius, vomiting, lethargy). Antibiotics may also be required if:
Age <2 years with bilateral AOM
Symptoms persisting past 48 hours
Severe symptoms (fever>39 degrees celsisus, moderate to severe otalgia)
Evidence of perforation
higher risk of complications (mastoiditis, chronic suppurative otitis media), immunodeficiency, uncertain access to follow up.
Control group
Active

Outcomes
Primary outcome [1] 303655 0
Percentage of children diagnosed with Acute Otitis Media, as recorded in the child's medical record.
Timepoint [1] 303655 0
The medical records for each child will be updated with the current diagnosis before the child is discharged from the emergency department. This will occur within 3 hours of admission to the emergency department.
Secondary outcome [1] 339798 0
A comparison of Length Of Stay times for children between the two groups. This will be determined by the Emergency Department records and the child's medical records.
Timepoint [1] 339798 0
This outcome will be recorded once the child attends the emergency department, when they are triaged and at completion of the visit/discharge from ED. Results for all children will be analysed for statistical significance at 12 months after randomisation, during the data analysis phase.
Secondary outcome [2] 340062 0
Percentage of children prescribed antibiotics for Acute Otitis Media. This will be determined by electronic chart review after the child has been discharged from the ED.
Timepoint [2] 340062 0
Data will be collected after the child has been discharged from the ED and within 1 week.

Eligibility
Key inclusion criteria
Children aged between 6 months and 5 years of age attending the Caboolture Hospital Emergency Department within normal office hours with suspected uncomplicated Acute Otitis Media.
Minimum age
6 Months
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include children outside the age range, recent antibiotic usage within 30 days and/or systemic features necessitating antibiotic treatment (including septicaemia, meningitis, pneumonia or urinary tract infection). Children will also be excluded if they have insitu grommets, chronic middle ear pathology and genetic conditions with anatomic abnormalities, include Downs Syndrome, cleft palate and immune deficiencies.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule (Chief investigator) who is “off-site” or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To detect a > 30% difference in the two groups, using a 2 –tailed alpha =.05 and a power of .80, each group requires 24 participants per condition. Data analysis will use a 2 tailed chi² and t – test to compare the antibiotic prescription rate, diagnosis and length of stay times in the ED between the two conditions.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/12/2017
Actual
Date of last participant enrolment
Anticipated
3/12/2018
Actual
Date of last data collection
Anticipated
3/12/2018
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9188 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 17838 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 297761 0
Government body
Name [1] 297761 0
Metro North Hospital and Health Service
Country [1] 297761 0
Australia
Primary sponsor type
Hospital
Name
Caboolture Hospital
Address
McKean St
Caboolture Qld 4510
Country
Australia
Secondary sponsor category [1] 296801 0
None
Name [1] 296801 0
Address [1] 296801 0
Country [1] 296801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298824 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298824 0
Ethics committee country [1] 298824 0
Australia
Date submitted for ethics approval [1] 298824 0
17/07/2017
Approval date [1] 298824 0
03/10/2017
Ethics approval number [1] 298824 0
HREC/17/QRCH/164

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2119 2119 0 0
/AnzctrAttachments/373823-AOM protocol V1.0.doc (Protocol)
Attachments [2] 2120 2120 0 0
/AnzctrAttachments/373823-Parent-Guardian Consent Form V2.doc (Participant information/consent)
Attachments [3] 2121 2121 0 0
/AnzctrAttachments/373823-Patient information Sheet V1.doc (Participant information/consent)
Attachments [4] 2122 2122 0 0
/AnzctrAttachments/373823-approval 031017.rtf (Ethics approval)

Contacts
Principal investigator
Name 78350 0
Dr Clive Holloway
Address 78350 0
Allied Health Department
Caboolture Hospital
McKean St
Caboolture Qld 4510
Country 78350 0
Australia
Phone 78350 0
+61 7 5433 8625
Fax 78350 0
Email 78350 0
[email protected]
Contact person for public queries
Name 78351 0
Clive Holloway
Address 78351 0
Caboolture Hospital
McKean St
Caboolture Qld 4510
Country 78351 0
Australia
Phone 78351 0
+61 7 5433 8625
Fax 78351 0
Email 78351 0
[email protected]
Contact person for scientific queries
Name 78352 0
Clive Holloway
Address 78352 0
Caboolture Hospital
McKean St
Caboolture Qld 4510
Country 78352 0
Australia
Phone 78352 0
+61 7 5433 8625
Fax 78352 0
Email 78352 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
No data - Recruitment not successful.


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.