Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000380998
Ethics application status
Approved
Date submitted
4/04/2011
Date registered
13/04/2011
Date last updated
13/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Do children between 1 and 6 years suffering from recurrent acute otitis media benefit from treatment with grommets.
Scientific title
The effect of ventilation tubes on recurrent acute otitis media in children 1-6 years.
Secondary ID [1] 259841 0
Nil
Universal Trial Number (UTN)
U1111-1120-2371
Trial acronym
NOROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent acute otitis media 265414 0
Condition category
Condition code
Ear 265574 265574 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insertion of ventilation tubes. Placing in the eardrum a grommet to ventilate the middle ear space. Administered under general anaesthetics. Duration 15 minutes.
Intervention code [1] 264260 0
Treatment: Surgery
Comparator / control treatment
Standard care. Participants are offered antibiotics if they are diagnosed with acute otitis media.
Control group
Active

Outcomes
Primary outcome [1] 262371 0
Number of middle ear infections. Diagnosed by ENT-doctor at check-up if there is a suspected infection.
Timepoint [1] 262371 0
1 year after inclusion
Primary outcome [2] 262372 0
Ear related quality of life measured with OM-6 and OMO-22
Timepoint [2] 262372 0
At regular intervals within 1 year (baseline, 3, 6, 9 and 12 months after inclusion)
Secondary outcome [1] 273648 0
Structural changes in the tympanic membrane. Clinical evaluation by ENT-doctor. Check list used.
Timepoint [1] 273648 0
The structure of the ear drum is evaluated at regular intervals (baseline, 3, 6, 9, 12 months)
Secondary outcome [2] 273649 0
Duration of ventilation tubes
Timepoint [2] 273649 0
Up to 1 year
Secondary outcome [3] 273650 0
Unwanted effects of ventilation tube insertion. Longstanding drainage, granulation tissue, persistent perforation after ventilation tube etc.) Clinical evaluation by ENT-doctor.
Timepoint [3] 273650 0
At regular intervals within 1 year (baseline, 3, 6, 9, 12 months or if infection is suspected)

Eligibility
Key inclusion criteria
4 episodes of acute otitis media during the last year or 3 episodes during the last 6 months; Childs caregivers must speak fluent english or norwegian
Minimum age
1 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous treatment with ventilation tubes; previous adenoidectomy or tonsillectomy; plans to move from district within follw-up time

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)
Central telephone or computer randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by computer generated random numbers
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 3307 0
Norway
State/province [1] 3307 0
Akershus
Country [2] 3308 0
Norway
State/province [2] 3308 0
Ostfold
Country [3] 3309 0
Norway
State/province [3] 3309 0
Hedmark
Country [4] 3310 0
Norway
State/province [4] 3310 0
Oppland
Country [5] 3311 0
Norway
State/province [5] 3311 0
Buskerud
Country [6] 3312 0
Norway
State/province [6] 3312 0
Vestfold
Country [7] 3313 0
Norway
State/province [7] 3313 0
Oslo

Funding & Sponsors
Funding source category [1] 264726 0
Hospital
Name [1] 264726 0
Akershus University Hospital
Country [1] 264726 0
Norway
Primary sponsor type
Hospital
Name
Akershus University Hospital
Address
Sykehusvn. 27
N-1478
Country
Norway
Secondary sponsor category [1] 263852 0
Individual
Name [1] 263852 0
Peder Aabel
Address [1] 263852 0
Akershus University Hospital
Sykehusvn. 27
N-1478
Country [1] 263852 0
Norway
Secondary sponsor category [2] 263853 0
Individual
Name [2] 263853 0
Magnus von Unge
Address [2] 263853 0
Akershus University Hospital
Sykehusvn. 27
N-1478
Country [2] 263853 0
Norway

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266714 0
The South-East Regional Committee for Medical and Health Research Ethics
Ethics committee address [1] 266714 0
Ethics committee country [1] 266714 0
Norway
Date submitted for ethics approval [1] 266714 0
Approval date [1] 266714 0
01/11/2010
Ethics approval number [1] 266714 0
2010/2600-1

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

Contacts
Principal investigator
Name 32371 0
Address 32371 0
Country 32371 0
Phone 32371 0
Fax 32371 0
Email 32371 0
Contact person for public queries
Name 15618 0
Peder Aabel
Address 15618 0
Akershus University Hospital
Sykehusvn. 27
N-1478 Lorenskog
Country 15618 0
Norway
Phone 15618 0
+47 02900
Fax 15618 0
Email 15618 0
[email protected]
Contact person for scientific queries
Name 6546 0
Magnus von Unge
Address 6546 0
Akershus University Hospital
Sykehusvn. 27
N-1478 Lorenskog
Country 6546 0
Norway
Phone 6546 0
+47 02900
Fax 6546 0
Email 6546 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.