Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users - Tabular View

Tracking Information
First Received Date ^ICMJE	July 28, 2008
Last Updated Date	October 17, 2008
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00725998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
Official Title ^ICMJE	Longitudinal Study Of The Evoked Compound Action Potential Measured In Children Cochlear Implant Users
Brief Summary	Introduction: In Cochlear Implant (CI) users, the recording of the electrically evoked compound action potential (ECAP) of the auditory nerve represents an option to assess changes in auditory nerve responses and the interaction between the electrode and the neural tissue over time. Aim: To study ECAP in children during the first year of CI use. Material and methods: The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. SERIES STUDY. Descriptors: Cochlear Implantation,cochlear nerve,child.
Detailed Description
Study Phase
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Other, Other
Condition ^ICMJE	Cochlear Nerve Disease
Intervention ^ICMJE
Study Arms / Comparison Groups	The ECAP characteristics have been analyzed in 13 children implanted younger than three years old. Series Study Results: During the first year of CI use there was a significant statistical growth for the amplitude of N1 peak, in basal electrodes, between the second and third returns. There were not any significant differences obtained for N1 peak, latency, slope, neither for p-NRT nor recovery time, among the returns.
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	This study selected only children implanted younger than three years old and followed them during their first year of CI use.
Gender	Both
Ages	up to 3 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Brazil

Administrative Information
NCT ID ^ICMJE	NCT00725998
Responsible Party
Study ID Numbers ^ICMJE	CEP 039/2004
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	University of Sao Paulo
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP