Trial Outcomes & Findings for Littlears Auditory Questionnaire: Validation Study in CI Children (NCT NCT00785707)
NCT ID: NCT00785707
Last Updated: 2017-06-26
Results Overview
The LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.
COMPLETED
31 participants
24 months
2017-06-26
Participant Flow
Participant milestones
| Measure |
Cochlear Implant
children less than 24 months at time of cochlear implantation
|
|---|---|
|
Overall Study
STARTED
|
31
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Cochlear Implant
children less than 24 months at time of cochlear implantation
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cochlear Implant
n=31 Participants
children less than 24 months at time of cochlear implantation
|
|---|---|
|
Age, Continuous
|
16.2 months
n=31 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire.
Outcome measures
| Measure |
Cochlear Implant
n=24 Participants
children less than 24 months at time of cochlear implantation
|
|---|---|
|
To Validate the LittleEARS Auditory Questionnaire
|
34.75 units on a scale
Interval 33.0 to 35.0
|
SECONDARY outcome
Timeframe: 24 monthsThe LittleEARS auditory questionnaire (LEAQ) uses parent responses to assess auditory behavior in children up to 24 months of age. The questionnaire is scored from 0 to 35 with 0 indicating poorer performance and 35 indicating better performance. There are no subscales for the questionnaire. This outcome measure is reported as a change on the LEAQ scale from initial CI fitting to 24 months.
Outcome measures
| Measure |
Cochlear Implant
n=24 Participants
children less than 24 months at time of cochlear implantation
|
|---|---|
|
Change in LEAQ Scale Score of Cochlear Implanted Children Over 24 Months After First CI Fitting
|
28.78 units on a scale
Interval 10.0 to 35.0
|
Adverse Events
Cochlear Implant
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place