Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000634774
Ethics application status
Approved
Date submitted
29/04/2013
Date registered
5/06/2013
Date last updated
5/06/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Swimming Study for Severe Otitis Media
Scientific title
A randomised controlled trial looking at the effects of swimming on chronic suppurative otitis media in Aboriginal aged 5-12 years living in the Northern Terrirtoy.
Secondary ID [1] 282412 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SSSOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 243600 0
Condition category
Condition code
Ear 239887 239887 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children in the intervention group took part in daily swimming classes (45 minutes) in a saltwater pool over 4 school weeks. Children swam without ear protection (cap or earplugs) and went frequently underwater.
Intervention code [1] 241188 0
Treatment: Other
Comparator / control treatment
Children in the control group were restricted from swimming in the pool for the 4 weeks of the intervention.
Control group
Active

Outcomes
Primary outcome [1] 240671 0
The proportion of children with an active tympanic membrane perforation. Ear examinations were conducted using tympanometry, pneumatic otoscopy and digital video otoscopy.
Timepoint [1] 240671 0
4 weeks after randomisation.
Secondary outcome [1] 257310 0
The proportion of children with; 1) S.pneumoniae, 2) H. influenzae, 3) M. catarrhalis, 4) Any respiratory pathogen (S. Pneumoniae, H. influenzae, M. catarrhalis), 5) S. aureus and 6) Gp A Streptococcus in the nasophayrnx. This secondary outcome was to assess the presence of respiratory bacteria in the nasopharynx

Swabs were taken from the nasopharynx. All swabs were cultured on selective media for respiratory bacteria. Swabs were kept in STGGB, Skin Milk Tryptone Glucose Glycerl Broth (WHO recommended O’Brien 2003) thawed and mixed. 10 microlitres aliquots were cultured on the following plates (Oxoid Australia): full Chocolate agar, 5% horse blood agar containing colisten and nalidixic acid (C.N.A), and chocolate agar with bacitracin, vancomycin, and clindamycin (BVCCA). Bacterial isolates were identified according to standard laboratory procedures.
Timepoint [1] 257310 0
4 weeks after randomisation.
Secondary outcome [2] 302504 0
The proportion of children with; 1) S. pneumoniae, 2) H. influenzae, 3) M. catarrhalis, 4) Any respiratory pathogen. This is a compound outcome to assess the presence of repiratory bacteria in the ears.

Swabs were taken from the middle ear. All swabs were cultured on selective media for respiratory bacteria. Swabs were kept in STGGB, Skin Milk Tryptone Glucose Glycerl Broth (WHO recommended O’Brien 2003) thawed and mixed. 10 microlitres aliquots were cultured on the following plates (Oxoid Australia): full Chocolate agar, 5% horse blood agar containing colisten and nalidixic acid (C.N.A), and chocolate agar with bacitracin, vancomycin, and clindamycin (BVCCA). Bacterial isolates were identified according to standard laboratory procedures.
Timepoint [2] 302504 0
4 weeks after randomisation
Secondary outcome [3] 303145 0
The proportion of children whose diagnosis (by child's worst ear) had improved. This included cases that had gone from: dry to closed, wet to closed, wet to dry.

This was a composite secondary outcome.
Timepoint [3] 303145 0
4 weeks after randomisation
Secondary outcome [4] 303146 0
The proportion of children whose diagnosis (by child's worst ear) had stayed the same over the intervention. This included cases that had gone from: dry to dry and wet to wet.

This was a composite secondary outcome
Timepoint [4] 303146 0
4 weeks after randomisation
Secondary outcome [5] 303147 0
The proportion of children whose diagnosis (by child's worst ear) had got worse. This included cases that had gone from dry to wet perforation.
Timepoint [5] 303147 0
4 weeks after randomisation
Secondary outcome [6] 303148 0
The proportion of children with 1) Gp A Streptococcus, 2) S. aureus, 3) P. aeruginosa and 4) Proteus in the middle ear.

Swabs were taken from the middle ear. Swabs of ear discharge were plated onto blood plates and MacConkey agar. Blood plates were incubated at 37°C in 5% CO² and MacConkey plates at 35°C in air. Bacterial isolates were identified according to standard laboratory procedures.

Timepoint [6] 303148 0
4 weeks after randomisation.

Eligibility
Key inclusion criteria
Children included in the study:1) were residents at the 2 participating communities, 2) were 5-12 years of age, 3) had a perforated eardrum and 4) were of Aboriginal heritage
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a medical condition that prohibited them from swimming were excluded from the trial.

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)
Children were randomly assigned to one of the two treatment groups. Groups were stratified by age to: children under the age of 8 on January 1, 2009 and children above the age of 8 on January 1, 2009. All clinical and laboratory assessors were blinded to the allocation sequence and what intervention participants received.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated on Stata Version 8.0 by the IT Division at the Menzies School of Health Research. Permuted block randomisation with randomly varying block sizes has been used to minimise any imbalances in the allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Single (examiner) blinded
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All participants randomised in the study contributed an outcome for clinical analysis. Children lost to followup were assumed to not have changed from their diagnosis at baseline but were excluded from assessments of microbiolgical outcomes. Risk differences between study groups were calculated with a 95% confidence interval. Semi quantitative measures for bacterial load were categorised as low density (<100) and high density (>100). Change in the density of all respiratory bacteria in the nasopharynx was calculated based on the new ordinal scale of low and high density.

It was hypothesised that 90% of children not swimming would have ear discharge at 28 days and that swimming could reduce this proportion. We specified that a 25% difference between the two groups would be clinically important. Our aim was to recruit a sample of 100 children to provide 80% power to detect a difference of 25% between the two groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/08/2009
Actual
17/08/2009
Date of last participant enrolment
Anticipated
6/11/2009
Actual
5/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 6807 0
0822 - Nguiu
Recruitment postcode(s) [2] 6808 0
0822 - Wadeye

Funding & Sponsors
Funding source category [1] 237545 0
Government body
Name [1] 237545 0
National Health and Medical Research Council
Country [1] 237545 0
Australia
Funding source category [2] 287188 0
Charities/Societies/Foundations
Name [2] 287188 0
Sidney Myer Fund
Country [2] 287188 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Menzies School of Health Research
Address
BLD 58 Royal Darwin Hospital
Rocklands Drive, Tiwi NT 0810
Country
Australia
Secondary sponsor category [1] 286143 0
None
Name [1] 286143 0
Address [1] 286143 0
Country [1] 286143 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289181 0
Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 289181 0
Ethics committee country [1] 289181 0
Australia
Date submitted for ethics approval [1] 289181 0
29/07/2009
Approval date [1] 289181 0
21/08/2009
Ethics approval number [1] 289181 0
EC00153

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30094 0
Ms Anna Stephen
Address 30094 0
Bld 58 Royal Darwin Hospital
Rocklands Drive
Casuarina, NT 0810
Country 30094 0
Australia
Phone 30094 0
+61 8 89228839
Fax 30094 0
Email 30094 0
[email protected]
Contact person for public queries
Name 13341 0
Anna Stephen
Address 13341 0
Bld 58 Royal Darwin Hospital
Rocklands Drive
Casuarina, NT, 0810
Country 13341 0
Australia
Phone 13341 0
+61 8 89228839
Fax 13341 0
Email 13341 0
[email protected]
Contact person for scientific queries
Name 4269 0
Peter Morris
Address 4269 0
Bld 58 Royal Darwin Hospital
Rocklands Drive
Casuarina, NT, 0810
Country 4269 0
Australia
Phone 4269 0
61 8 89228371
Fax 4269 0
Email 4269 0
[email protected]

No information has been provided regarding IPD availability


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.