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Trial record 5 of 8 for:    auditory brainstem implant | Child

Auditory Brainstem Implantation in Young Children

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ClinicalTrials.gov Identifier: NCT01904448
Recruitment Status : Completed
First Posted : July 22, 2013
Results First Posted : June 6, 2018
Last Update Posted : July 4, 2018
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Developmental Cochlear Nerve Deficiency
Acquired Cochlear Nerve Deficiency
Cochlear Aplasia
Post-meningitis Cochlear Ossification
Cochlear Malformation
Intervention Device: Auditory Brainstem Implantation in Children
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pediatric Auditory Brainstem Implantation (ABI)
Hide Arm/Group Description Single-arm study of Auditory Brainstem Implantation (ABI) in children
Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Pediatric ABI
Hide Arm/Group Description Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
5
 100.0%
Between 18 and 65 years
0
   0.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 5 participants
3.4
(2.1 to 5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
  20.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
  80.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
 100.0%
1.Primary Outcome
Title Number of ABI Complications
Hide Description Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.
Time Frame Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: Events
2
2.Secondary Outcome
Title The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Hide Description OWLS-II: Listening Comprehension measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participant and he/she responds by pointing to or stating which of four pictures is correct. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better listening comprehension. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Time Frame Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: units on a scale
Subject 1 77
Subject 2 46
Subject 3 40
Subject 4 40
Subject 5 62
3.Secondary Outcome
Title The Oral and Written Language Scales (OWLS) Oral Expression Score
Hide Description OWLS-II: Oral Expression measures oral language expression, which is the use of spoken language. The examiner presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better oral expression. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Time Frame Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: units on a scale
Subject 1 48
Subject 2 50
Subject 3 40
Subject 4 40
Subject 5 58
4.Secondary Outcome
Title Goldman-Fristoe Test of Articulation Scores (GFTA)
Hide Description The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.
Time Frame Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Due to limited progress in spoken language development and test difficulty, this measure was replaced by Identifying Early Phonological Needs in children with hearing loss (IEPN). No data were collected for this measure.
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title MacArthur-Bates Communicative Development Inventories (CDIs) Score
Hide Description MacArthur-Bates Communicative Development Inventories (CDIs)
Time Frame Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Hide Description This is a measure of the child's ability to vocalize on demand elicited by pictures of objects. Scores are derived from the percentage of time the child vocalized for 25 words.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 100
Subject 1 Year 2 100
Subject 1 Year 3 100
Subject 2 Year 1 0
Subject 2 Year 2 100
Subject 2 Year 3 100
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 44
Subject 4 Year 1 100
Subject 4 Year 2 100
Subject 4 Year 3 100
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
7.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Hide Description Measure of percent correct for use of syllables elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct number of syllables on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 40
Subject 1 Year 2 80
Subject 1 Year 3 92
Subject 2 Year 1 0
Subject 2 Year 2 40
Subject 2 Year 3 80
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 40
Subject 4 Year 1 60
Subject 4 Year 2 100
Subject 4 Year 3 60
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
8.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Hide Description Measure of percent correct on initial consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced an initial consonant on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 63
Subject 1 Year 2 95
Subject 1 Year 3 100
Subject 2 Year 1 0
Subject 2 Year 2 66
Subject 2 Year 3 75
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 16
Subject 4 Year 1 71
Subject 4 Year 2 38
Subject 4 Year 3 60
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
9.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Hide Description Measure of percent correct on vowel production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct vowel on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 12
Subject 1 Year 2 31
Subject 1 Year 3 53
Subject 2 Year 1 0
Subject 2 Year 2 12
Subject 2 Year 3 26
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 20
Subject 4 Year 1 28
Subject 4 Year 2 17
Subject 4 Year 3 45
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
10.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Hide Description Measure of percent correct on consonant manner cues production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct manner of consonant production on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 18
Subject 1 Year 2 54
Subject 1 Year 3 56
Subject 2 Year 1 0
Subject 2 Year 2 24
Subject 2 Year 3 24
Subject 3 Year 1 0
Subject 3 Year 2 4
Subject 3 Year 3 4
Subject 4 Year 1 35
Subject 4 Year 2 25
Subject 4 Year 3 37
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
11.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Hide Description Measure of percent correct on final consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced a final consonant on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 29
Subject 1 Year 2 64
Subject 1 Year 3 94
Subject 2 Year 1 0
Subject 2 Year 2 0
Subject 2 Year 3 0
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 11
Subject 4 Year 1 11
Subject 4 Year 2 41
Subject 4 Year 3 41
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
12.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Hide Description Measure of percent correct on consonant place cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct place of consonant production on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 20
Subject 1 Year 2 58
Subject 1 Year 3 58
Subject 2 Year 1 0
Subject 2 Year 2 27
Subject 2 Year 3 27
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 5
Subject 4 Year 1 28
Subject 4 Year 2 21
Subject 4 Year 3 38
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
13.Secondary Outcome
Title Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Hide Description Measure of percent correct on consonant voicing cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct voicing of consonant production on 25 items.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percentage of correct answers
Subject 1 Year 1 16
Subject 1 Year 2 67
Subject 1 Year 3 90
Subject 2 Year 1 0
Subject 2 Year 2 41
Subject 2 Year 3 25
Subject 3 Year 1 0
Subject 3 Year 2 0
Subject 3 Year 3 3
Subject 4 Year 1 41
Subject 4 Year 2 20
Subject 4 Year 3 51
Subject 5 Year 1 0
Subject 5 Year 2 0
Subject 5 Year 3 0
14.Secondary Outcome
Title Change in Speech Perception Test Battery Scores-Detection Audiogram
Hide Description Sound detection for octave frequencies of 250 Hz through 8k Hz were collected and a 4 frequency average was calculated for each annual test interval
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-Arm Study of Auditory Brainstem Implantation (ABI) in Children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: averaged decibel level
Pure Tone Average (PTA) Subject 1 Year 1 30
PTA Subject 1 Year 2 42
PTA Subject 1 Year 3 30
PTA Subject 2 Year 1 120
PTA Subject 2 Year 2 47
PTA Subject 2 Year 3 35
PTA Subject 3 Year 1 33
PTA Subject 3 Year 2 32
PTA Subject 3 Year 3 30
PTA Subject 4 Year 1 32
PTA Subject 4 Year 2 30
PTA Subject 4 Year 3 33
PTA Subject 5 Year 1 35
PTA Subject 5 Year 2 33
PTA Subject 5 Year 3 32
15.Secondary Outcome
Title Speech Perception Test Battery Scores-IT-MAIS or MAIS
Hide Description

A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until demonstrating a minimum performance on the previous measure.

The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is a parent questionnaire consisting of ten questions regarding a young infant or toddler's auditory behavior, e.g., "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The aim of this tool is to assess the benefit of the child's personal amplification device(s) and is used to assess hearing aid benefit. Higher scores reflect more consistent auditory response. Scores reported are the percentage of correctly answered questions of the total asked.

Time Frame Pre-ABI, Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percent correct
Subject 1 Pre-ABI 3
Subject 1 Year 1 43
Subject 1 Year 2 32
Subject 1 Year 3 42
Subject 2 Pre-ABI 0
Subject 2 Year 1 28
Subject 2 Year 2 12
Subject 2 Year 3 72
Subject 3 Pre-ABI 0
Subject 3 Year 1 52
Subject 3 Year 2 70
Subject 3 Year 3 33
Subject 4 Pre-ABI 75
Subject 4 Year 1 50
Subject 4 Year 2 55
Subject 4 Year 3 52
Subject 5 Pre-ABI 0
Subject 5 Year 1 2
Subject 5 Year 2 5
Subject 5 Year 3 0
16.Secondary Outcome
Title Change in Speech Perception Test Battery Scores-Ling Sound Test
Hide Description

A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.

The Ling- 6 sounds test is a speech sound detection measurement of detection thresholds performed by an audiologist. Six sound files of “ah”, “ee”, “oo”, “sh”, “s”, and “m” are presented one at a time in varying order for measurement of hearing threshold groups, per sound. The selected sounds tested validate hearing device fitting across the frequency range important for understanding speech. If the child can detect the stimuli a point is given and if they can not detect, no point is given. A total of 3 trials per sound were presented for a total of 18 presentations. The score reflects a percent of the total sounds that were detected.

Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: percent correct
Ling 6 Subject 1 Year 1 100
Ling 6 Subject 1 Year 2 100
Ling 6 Subject 1 Year 3 100
Ling 6 Subject 2 Year 1 0
Ling 6 Subject 2 Year 2 100
Ling 6 Subject 2 Year 3 100
Ling 6 Subject 3 Year 1 100
Ling 6 Subject 3 Year 2 100
Ling 6 Subject 3 Year 3 100
Ling 6 Subject 4 Year 1 100
Ling 6 Subject 4 Year 2 100
Ling 6 Subject 4 Year 3 100
Ling 6 Subject 5 Year 1 100
Ling 6 Subject 5 Year 2 100
Ling 6 Subject 5 Year 3 100
17.Secondary Outcome
Title Change in Speech Perception Test Battery Scores-ESP Low Verbal
Hide Description

A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure.

The Early Speech Perception (ESP) low verbal version estimates speech perception abilities in very young children who have limited verbal abilities. Stimuli consist of words varying in pattern as well as spondees and monosyllabic words presented in sets of four. The format is four item closed-set. Test materials consist of objects (toys) instead of pictures. It is scored by the percent of correctly identified items from the set of 4; 3 repetitions of each item are given for a total of 12 trials.

Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Missing values indicate test was not administered at that interval and ESP-Standard was administered.
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of correct answers
Pattern Subject 1 Year 1 25
Monosyllable Subject 1 Year 1 58
Spondee Subject 1 Year 1 25
Pattern Subject 1 Year 2 100
Monosyllable Subject 1 Year 2 75
Spondee Subject 1 Year 2 67
Pattern Subject 2 Year 1 25
Monosyllable Subject 2 Year 1 25
Spondee Subject 2 Year 1 25
Pattern Subject 2 Year 2 25
Monosyllable Subject 2 Year 2 25
Spondee Subject 2 Year 2 25
Pattern Subject 2 Year 3 25
Monosyllable Subject 2 Year 3 25
Spondee Subject 2 Year 3 25
Pattern Subject 3 Year 1 25
Monosyllable Subject 3 Year 1 25
Spondee Subject 3 Year 1 25
Pattern Subject 3 Year 2 83
Monosyllable Subject 3 Year 2 25
Spondee Subject 3 Year 2 25
Pattern Subject 5 Year 1 25
Monosyllable Subject 5 Year 1 25
Spondee Subject 5 Year 1 25
Pattern Subject 5 Year 2 25
Monosyllable Subject 5 Year 2 25
Spondee Subject 5 Year 2 25
Pattern Subject 5 Year 3 25
Monosyllable Subject 5 Year 3 25
Spondee Subject 5 Year 3 25
18.Secondary Outcome
Title Change in Speech Perception Test Battery Scores-ESP Standard
Hide Description A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. This may have been due to child's age or inability to complete task. The Early Speech Perception (ESP) Standard measures the progression of speech discrimination skills in children (age 5+) with profound hearing loss as they develop. The stimuli consist of 3 subtests [1) patterns and words, 2) monosyllable, 3) spondees] of 12 pictured words each presented in an auditory-only condition. The format is a closed-set. Two repetitions of each item are given for a total of 24 items for each subtest. Each subtest is scored by the percent of correctly identified items from the set of pictured words.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Missing values indicate test was not administered at that interval and ESP-LV (Low Verbal) was administered.
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: percentage of correct answers
Pattern Subject 1 Year 3 70
Word Subject 1 Year 3 62
Monosyllable Subject 1 Year 3 50
Spondee Subject 1 Year 3 41
Pattern Subject 3 Year 2 66
Word Subject 3 Year 2 41
Monosyllable Subject 3 Year 2 25
Spondee Subject 3 Year 2 25
Pattern Subject 3 Year 3 46
Word Subject 3 Year 3 29
Monosyllable Subject 3 Year 3 25
Spondee Subject 3 Year 3 25
Pattern Subject 4 Year 1 50
Word Subject 4 Year 1 45
Monosyllable Subject 4 Year 1 25
Spondee Subject 4 Year 1 25
Pattern Subject 4 Year 2 45
Word Subject 4 Year 2 41
Monosyllable Subject 4 Year 2 16
Spondee Subject 4 Year 2 25
Pattern Subject 4 Year 3 53
Word Subject 4 Year 3 42
Monosyllable Subject 4 Year 3 8
Spondee Subject 4 Year 3 42
19.Secondary Outcome
Title Pre-School Language Scale (PLS-5) Scores
Hide Description The PLS-5 is a standardized language test designed for infants and young children. The Auditory Comprehension subscale targets skills known to precede language development, including: attention to speakers, appropriate object play, basic vocabulary, concepts, grammatical markers, and complex sentences. The Expressive Communication subscale assesses vocal development, social communication, naming of common objects, phonological awareness, sequencing skills, as well as use of concepts, prepositions, grammatical markers, and varying sentence structures.
Time Frame Year 1, Year 2, Year 3
Hide Outcome Measure Data
Hide Analysis Population Description
Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.
Arm/Group Title Pediatric ABI
Hide Arm/Group Description:
Single-arm study of Auditory Brainstem Implantation (ABI) in children
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event data were collected during the three year study course following enrollment for each participant.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pediatric ABI
Hide Arm/Group Description Single-arm study of Auditory Brainstem Implantation (ABI) in children
All-Cause Mortality
Pediatric ABI
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Pediatric ABI
Affected / at Risk (%) # Events
Total   2/5 (40.00%)    
Surgical and medical procedures   
Cerebral Spinal Fluid (CSF) Leak  [1]  1/5 (20.00%)  1
Aseptic Meningitis  [2]  1/5 (20.00%)  1
Indicates events were collected by systematic assessment
[1]
CSF wound leakage requiring second surgery to reinforce close and placement of lumbar drain.
[2]
Presumptive diagnosis of bacterial meningitis although negative gram stain and cultures throughout. Treated with six weeks of IV antibiotics with resolution.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pediatric ABI
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
This study included only 5 participants and statistically reliable results were not possible. There was a floor effect for measures chosen to demonstrate device efficacy; they were found to be unspecific and insensitive to change observed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Craig A. Buchman, MD, FACS
Organization: University of North Carolina at Chapel Hill
Phone: 314-362-7395
EMail: buchmanc@wustl.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01904448     History of Changes
Other Study ID Numbers: 12-0664
First Submitted: July 3, 2013
First Posted: July 22, 2013
Results First Submitted: March 27, 2018
Results First Posted: June 6, 2018
Last Update Posted: July 4, 2018