Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000558729
Ethics application status
Approved
Date submitted
10/05/2013
Date registered
17/05/2013
Date last updated
17/05/2023
Date data sharing statement initially provided
14/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
An observational study that evaluates the improvements in auditory performance (hearing) and health related benefits (quality of life) achieved by children using implantable hearing devices: Cochlear Paediatric Implanted Recipient Observational Study (Cochlear P-IROS)
Scientific title
A global prospective observational study (patient registry) to assess the effectiveness of implantable hearing devices in children implanted at < 10 years of age, in their everyday life.
Secondary ID [1] 282470 0
'Nil known'
Universal Trial Number (UTN)
Trial acronym
Cochlear P-IROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing impairment 289089 0
Condition category
Condition code
Ear 289431 289431 0 0
Deafness

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The use of cochlear implants, bone conduction implants, other implantable hearing devices in the treatment of hearing loss , over a period of 2 years (minumum)- 5 years (maximum) post implantation.
Intervention code [1] 287117 0
Not applicable
Comparator / control treatment
Intra-subject comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289561 0
Intra-subject comparison of post-implantation auditory skills (CAP_II)
Timepoint [1] 289561 0
Each subject will be evaluated at 0, Months, 6 months, 12 months, 18 months and 24months post implantation

Those continuing in the study, after two years, will be assessed on annual basis. That is at 3 years, 4 years and 5 years post implantation.
Secondary outcome [1] 302744 0
Inter-subgroup comparison of auditory skills (CAP-II and SSQ for Parents)
Timepoint [1] 302744 0
The evaluation timepoints are baseline (0 months), 6 months, 12months, 18 months and 24 months post implantation.

Those continuing in the study, after two years, will be assessed on annual basis. That is at 3 years, 4 years and 5 years post implantation

Eligibility
Key inclusion criteria
Children < 10 years of age at time of first implantation;
Received an regulatory approved implantable hearing device/s;
Minimum age
No limit
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior experience with an implantable hearing device
Implantable devices not yet approved for sale by regulatory authority

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
28/01/2013
Actual
1/02/2013
Date of last participant enrolment
Anticipated
1/12/2025
Actual
31/08/2021
Date of last data collection
Anticipated
1/12/2025
Actual
31/08/2021
Sample size
Target
2000
Accrual to date
Final
1138
Recruitment outside Australia
Country [1] 5076 0
India
State/province [1] 5076 0
Gujarat, Maharashtra, New Delhi, Telangana
Country [2] 5077 0
China
State/province [2] 5077 0
Shandong, Beijing, Anhui,
Country [3] 7774 0
Belarus
State/province [3] 7774 0
Minsk
Country [4] 7775 0
Cuba
State/province [4] 7775 0
Havana
Country [5] 7776 0
Germany
State/province [5] 7776 0
North Rhine-Westphalia
Country [6] 7777 0
Indonesia
State/province [6] 7777 0
Jakarta
Country [7] 7778 0
Israel
State/province [7] 7778 0
Haifa, Jerusalem
Country [8] 7779 0
Portugal
State/province [8] 7779 0
Porto
Country [9] 7780 0
South Africa
State/province [9] 7780 0
Western Cape, Gauteng, KwaZulu-Natal, Free State, Eastern Cape
Country [10] 7781 0
Taiwan, Province Of China
State/province [10] 7781 0
Taipei
Country [11] 7782 0
Turkey
State/province [11] 7782 0
Ankara, Istanbul, Gaziantep, Adana, Izmir, Eskisehir, Kocaeli, Denizli, Antakya
Country [12] 7783 0
Ukraine
State/province [12] 7783 0
Sumy, Kiev
Country [13] 8989 0
Malaysia
State/province [13] 8989 0
Selangor
Country [14] 22354 0
Armenia
State/province [14] 22354 0
Yerevan
Country [15] 22355 0
Hungary
State/province [15] 22355 0
Csongrad

Funding & Sponsors
Funding source category [1] 287268 0
Commercial sector/Industry
Name [1] 287268 0
Cochlear Limited
Country [1] 287268 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Cochlear Limited
Address
No 1 University Avenue
Macquarie University, NSW 2109
Country
Australia
Secondary sponsor category [1] 286021 0
None
Name [1] 286021 0
Address [1] 286021 0
Country [1] 286021 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289248 0
Peking University Third Hospital
Ethics committee address [1] 289248 0
Peking University Third Hospital
No 49 Garden Road,
Haidian District, Beijing 100191
Ethics committee country [1] 289248 0
China
Date submitted for ethics approval [1] 289248 0
27/05/2013
Approval date [1] 289248 0
Ethics approval number [1] 289248 0
Ethics committee name [2] 294765 0
Institutional Ethics Committee Columbia Asia Hospitals
Ethics committee address [2] 294765 0
26/4 Brigade gateway, Beside Metro, Malleshwaram West, Bangalore - 560 055
Ethics committee country [2] 294765 0
India
Date submitted for ethics approval [2] 294765 0
Approval date [2] 294765 0
24/04/2015
Ethics approval number [2] 294765 0
Ethics committee name [3] 294766 0
MacKay Memorial Hospital Institutional Review Board
Ethics committee address [3] 294766 0
No.92, Sec. 2, Zhongshan N. Rd., Zhongshan Dist., Taipei City 104, Taiwan (R.O.C.)
Ethics committee country [3] 294766 0
Taiwan, Province Of China
Date submitted for ethics approval [3] 294766 0
Approval date [3] 294766 0
06/11/2014
Ethics approval number [3] 294766 0
Ethics committee name [4] 297226 0
Institute Ethics Committee - All India Institute of Medical Sciences
Ethics committee address [4] 297226 0
AIIMS
Room No 102, 1st Floor OLD O.T. Block,
Ansari Nagar, New Delhi 110029
India
Ethics committee country [4] 297226 0
India
Date submitted for ethics approval [4] 297226 0
01/04/2016
Approval date [4] 297226 0
13/10/2016
Ethics approval number [4] 297226 0
IEC-174-174/01.04.2016, AA-2/ 07.10.2016
Ethics committee name [5] 297978 0
Research Ethics Committee - The National University of Malaysia
Ethics committee address [5] 297978 0
Sukmaria
3rd Floor, Block Clinical
UKM Medical Centre, Cheras
Kuala Lumpur
Malaysia
Ethics committee country [5] 297978 0
Malaysia
Date submitted for ethics approval [5] 297978 0
01/06/2016
Approval date [5] 297978 0
13/04/2017
Ethics approval number [5] 297978 0
07/2017

Summary
Brief summary
To address these reported gaps in the literature regarding the clinical efficacy of implantable hearing devices, a global prospective observational study (a patient registry) has been developed to assess the effectiveness of hearing habitation with the aid of implantable hearing devices in infants and young children up to the age of 10 years, in their everyday life.
Trial website
Trial related presentations / publications
Public notes
Observational studies do not require EC approval in all jurisdictions.

The first centre to join the trial and recruit patients did not require EC. This means that he first patients recruited occured before the first EC approval was granted, which is appropriate in this context.

No patients will be recruited before EC approval is granted in a jurisdiction in which EC approval is applicable.

Contacts
Principal investigator
Name 39890 0
Ms Jasmin Kaur
Address 39890 0
Cochlear AG
Peter Merian-Weg 4
4052 Basel
Country 39890 0
Switzerland
Phone 39890 0
+41612058207
Fax 39890 0
Email 39890 0
[email protected]
Contact person for public queries
Name 39891 0
Jasmin Kaur
Address 39891 0
Cochlear AG
Peter Merian-Weg 4
4052 Basel
Country 39891 0
Switzerland
Phone 39891 0
+41612058207
Fax 39891 0
Email 39891 0
[email protected]
Contact person for scientific queries
Name 39892 0
Jasmin Kaur
Address 39892 0
Cochlear AG
Peter Merian-Weg 4
4052 Basel
Country 39892 0
Switzerland
Phone 39892 0
+41612058207
Fax 39892 0
Email 39892 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


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
SourceTitleYear of PublicationDOI
Dimensions AILongitudinal outcomes for educational placement and quality of life in a prospectively recruited multinational cohort of children with cochlear implants2023https://doi.org/10.1016/j.ijporl.2023.111583
N.B. These documents automatically identified may not have been verified by the study sponsor.