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CHIMES STUDY: CONGENITAL CHIMES STUDY: CONGENITAL CYTOMEGALOVIRUS INFECTION AND CYTOMEGALOVIRUS INFECTION AND HEARING MULTICENTER SCREENING HEARING MULTICENTER SCREENING
STUDYSTUDY
Karen Fowler, DrPHUniversity of Alabama in Birmingham
Faye P. McCollister, EdDUniversity of Alabama, Emeritus
Diane Sabo, PhDUniversity of Pittsburgh
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Confusion Regarding Congenital Confusion Regarding Congenital CMV Infection & Hearing LossCMV Infection & Hearing Loss
Studies/Reports of etiology of pediatric hearing loss seldom include routine screening for congenital CMV infection
Most congenital CMV infection is asymptomatic (90%)
No profile for audiometric configuration is available
Hearing may be normal; loss may be unilateral or bilateral; present at birth or delayed in onset; may be fluctuating and/or may be progressive
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•Common virus although not easily spread person to person
•Diagnosis needs to be made in the first 3 weeks of life
•Clinical observation of infection in the newborn period identifies < 5% of all infants with congenital CMV infection
•Delayed onset sequelae may occur over a long period with sensorineural hearing loss being the most common
Review of Congenital CMV Review of Congenital CMV InfectionInfection
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Review of Congenital CMV and Review of Congenital CMV and Hearing Loss ResearchHearing Loss Research
1960s - CID/symptomatic CMV infection and hearing loss first reported. Medearis, l964; McCracken, et al. 1969
1970s - inapparent / asymptomatic CMV infection and HL was first reported. Reynolds, et al. 1974; Dahle, et al. 1974; Hanshaw, et al. 1976; Stagno, et al. 1977
1970s & 1980s, progression and delayed onset HL first described. Dahle, et al, 1979; Williamson et al. 1982
3.9% at birth will have hearing loss; 8.3% at 6 yrs Symptomatic infection – 16.5% HL at birth; 36.4% at 6 yrs Asymptomatic infection – 2.9% HL at birth; 11.3% at 6 yrs
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The Natural History of CMV-Related Hearing Loss and the Feasibility of
CMV Screening as Adjunct to Hearing in the Newborn
NIH/NIDCD ContractNIH/NIDCD Contract
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CHIMES StudyCHIMES Study
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NIDCD CMV Grant, UABNIDCD CMV Grant, UAB
Multi-site investigation, 7 sites 100,000 newborns to be screened for
congenital CMV infection Link newborn hearing results Evaluate methods for CMV screening
Saliva vs. dried blood spots (DBS) Audiological follow up of CMV positive
infants for 4 years
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Screen at least 100,000 newborns for CMV infection who currently undergo newborn hearing screening
Audiological follow-up of all CMV positive infants
Compare the accuracy of two diagnostic methods for CMV screening (traditional rapid saliva cell culture vs. real time PCR on DBS)
Project DesignProject Design
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Define the long-term audiologic/otologic outcome in children with congenital CMV infection
Determine the clinical validity and utility of CMV screening:
in the detection of hearing impairment in the newbornin the prediction of hearing impairment with onset during infancy or in the early years of life
ObjectivesObjectives
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Project StaffProject Staff
The project is directed by Drs. Suresh Bopanna & Karen Fowler
Each site will have a person designated as a co-principal investigator
Site audiologists direct audiological assessments
Project consultants: Faye McCollister, Judy Gravel, Karl White
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Site AudiologistsSite Audiologists
Julie Woodruff Birmingham, AL Belinda Blackstone Birmingham, AL William Mustain Jackson, MS Marci Schwab New Brunswick, NJ Edie Cox Charlotte, NC David Brown Cincinnati, OH Dan Choo Cincinnati, OH John Greinwald Cincinnati, OH Diane Sabo Pittsburgh, PA Angela Shoup Dallas, TX Kris Owen Dallas, TX
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Birmingham, ALUniversity Hospital & Cooper Green Hospital
Jackson, MSUniversity of Mississippi Medical Center
New Brunswick, NJSaint Peters University Hospital
Charlotte, NCCarolinas Medical Center
Cincinnati, OHGood Samaritan Hospital
Pittsburgh, PAMagee Women’s Hospital
Dallas, TXParkland Memorial Hospital
Participating Hospitals
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38% Caucasian, Non Hispanic
34% Caucasian, Hispanic
24% African American
4% Asian
Selected Hospital PopulationsSelected Hospital Populations
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Challenges to the CHIMES Challenges to the CHIMES Study (1)Study (1)
Establishing consistency in protocols across 7 sites, getting everyone on the same page
Challenges inherent in longitudinal investigation: 6 year period of study, equipment changes, staff changes, protocol changes
Age of subjects, birth through age 4 years, more difficult to evaluate audiologically
Multiple disabilities, including developmental, vision, and motor for children with symptomatic infection
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Challenges to the CHIMES Challenges to the CHIMES Study (2)Study (2)
Variability of hearing loss: progression, delay in onset, and fluctuation
Subject ethnic background with language differences, cultural differences, social differences
Otitis media resulting in conductive overlay for sn hearing loss, delay in getting assessment data
Subject compliance with study protocol Subject retention
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Challenges to the CHIMES Challenges to the CHIMES Study (3)Study (3)
Specified protocol modified to accommodate clinical needs with rapidly progressive hearing loss
Accuracy/consistency in data collection, recording, transfer, and storage
Interpretation of data and clinical judgment
Ensuring client confidentiality
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Addressing the ChallengesAddressing the Challenges to the CHIMES Study to the CHIMES Study
Standardized collection of data: developed data forms using barcoded labels with unique study identifier for all data sent from 7 sites (scanned and processed)
Developed detailed Manual of Procedures (MOP) for study policies and procedures
Developed audiology protocols establishing optimal and minimal goals for audiology data at visits
Site Visits and Review of protocols Detailed retention plan with computerized database
at each site and data forms (Visit Forms & Missed Visit Forms) to collect information on amount of contact each site had with a study participant during the intervals between visits
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Addressing the Challenges to the Addressing the Challenges to the CHIMES StudyCHIMES Study
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Subject VariablesSubject Variables
Additional Disabilities (symptomatic infection)Vision
Can not see visual reinforcersCan not process visual instructionsNeed glasses for assessment, if prescribed
Seizure disorderFlicker stimulation with lighted reinforcerAbsence, petit mal, and grand mal seizures
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Cultural DiversityCultural Diversity Racial, cultural, socioeconomic differences
exist among individuals from same country Interpreters may have difficulty explaining
medical / technical information May be difficult for family to understand will not qualify for public assistance
medical and technical services (hearing aids)
finding financial assistance challenging, at best
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Cultural DiversityCultural Diversity
Project informational materials will be provided in English and Spanish for parents and at understandable reading levels.
Communication options chosen by families for their child will be respected and supported.
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CHIMES STUDY CHIMES STUDY
Audiological Assessment Protocol
Diane Sabo, PhDUniversity of Pittsburgh
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Components of Study Components of Study Audiological AssessmentAudiological Assessment
ABR tone bursts, bone conduction, Otoacoustic emissions, (DPs) Immittance with high frequency probe for
subjects less than 7 months of age, only when conductive involvement needs greater definition
Behavioral assessmentVRAPlay
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Screening Data ObtainedScreening Data Obtained
Physiologic dataABRAutomated-ABROAEsAutomated OAEsCombinations of the tests
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Objective Hearing Diagnostic Objective Hearing Diagnostic MethodsMethods
Auditory Brainstem Response (ABR) Tone Bursts –air and bone conduction
Auditory Steady State Response (ASSR) not required, optional
Acoustic Immittance Evoked Otoacoustic Emissions (EOAEs)
Distortion Product OAEs (DPOAEs)
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Entry or Baseline DataEntry or Baseline Data
Physiologic tests ABR
Tone bursts at .5, 1, 2 and 4k HzBone conduction if air conduction
abnormal (>25) DPOAEs
2-8k Hz60/45Signal and noise levels recorded
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Physiologic Assessment with Physiologic Assessment with ABR and EOAEsABR and EOAEs
• Advantages• “Objective”• Reliable• Correlate well with hearing• Age not a factor (but sometimes an issue)
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Physiologic Assessment Physiologic Assessment with ABR and EOAEswith ABR and EOAEs
LimitationsNot completely “objective”Not tests of hearingNot always good at predicting
thresholdNot independent of infant’s
behavior, state, or other factors
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Click SpectrumClick Spectrum
Frequency
FrequencyFrequency
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Comparison of Frequency Range for Comparison of Frequency Range for ABR Clicks and Tone BurstsABR Clicks and Tone Bursts
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What We Know About ABR ClicksWhat We Know About ABR Clicks
Click commonly used, but……can give misleading informationClick has energy at all frequencies transduced
by earphoneWithin limits, regions of normal hearing will
generate ABR, even with regions of hearing loss
ABR tests avoid problems associated with reverse middle ear transmission, but potential still exists for missing hearing loss with click-evoked ABR
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Progressive HL Secondary to SX Progressive HL Secondary to SX CMV in Six Month PeriodCMV in Six Month Period
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ABR Assessment at Enrollment ABR Assessment at Enrollment Visit Visit
Enrollment visit at 3-6 weeks of age Objective is to obtain valid/accurate
estimates of ear specific, frequency specific hearing thresholds for each ear and to characterize the type of any permanent loss present as baseline information
Case history/parent observation reportOtoscopic inspectionDPOAE
Medical referral if testing deferred because of otologic problems
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Physiologic Assessment with Physiologic Assessment with ABR and EOAEsABR and EOAEs
• Advantages• “Objective”• Reliable• Correlate well with hearing• Age not a factor (but sometimes an issue)
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Optimal Goal for ABR Assessment at Optimal Goal for ABR Assessment at Enrollment Visit (3-6 Weeks)Enrollment Visit (3-6 Weeks)
ABR minimum response levels at .5, 1.0, 2.0, and 4.0 kHz for each ear
DPOAE information at five frequency bands centered at 2,3,4,6, and 8
Bone conduction, tympanometry, and ipsilateral reflexes may be required if loss suspected
Record on ABR data form CF107 Record on OAE data form Record on immittance data form CF110
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Minimal Goal for ABR Assessment Minimal Goal for ABR Assessment at Enrollment Visit at 3-6 Weeks at Enrollment Visit at 3-6 Weeks
of Ageof Age
Due to the importance of obtaining baseline information that is a clear and accurate reflection of infant’s hearing level a minimum goal was set: Obtain MRL at 0.5, 2.0, and 4.0 kHz for each ear Bone conduction, tympanometry, and ipsilateral
acoustic reflexes may be necessary if loss is suspected
If additional assessment apt necessary, use sequence system of 1,2, and 3 on forms for enrollment visit
Prolonged delays between assessments avoided if possible
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ABR ProtocolABR Protocol
Order for tone bursts: 2000, 4000, 500 and 1000
Use 2-0-2 for 500 Hz Use 4-0-4 for Rate 27-29 Filter setting of 30-3000 Two replications <1000 sweeps for 2.0 and 4.0 No less than 2000 sweeps for 0.5 and 1.0
kHz
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ABR ParametersABR Parameters
15-20 msec window At least two replications at no response
level and next level up, using a 10dB step above the last response level; threshold determination is midpoint between these two levels
Electrode configuration of high forehead to earlobe, with low forehead as ground; assuming a two channel recording
Insert earphones
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Entry DataEntry Data
Acoustic Immittance Data Tympanometry
High frequency tymps (1k) < 7 months
Acoustic reflex thresholdsIPSI reflexes @ 1k only, if necessary
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Use Insert EarphonesUse Insert Earphones
Separation of stimulus artifact from the onset of the response makes wave I more visible
Prevent ear canal collapse Increase interaural attenuation Provide greater comfort for long periods of
time Can attenuate surrounding environmental
noise more efficiently Absolute latencies delayed by 0.9ms Affect amplitude of wave I, lower
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CHIMES STUDYCHIMES STUDY
Faye P. McCollister, EdDUniversity of Alabama, Emeritus
Behavioral AudiologicalAssessment Protocols
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Request Parental Help in Preparing for Request Parental Help in Preparing for Behavioral Diagnostic AssessmentBehavioral Diagnostic Assessment
Try to have child rested and feed,
comfortable and attentive for test Schedule appointment away from nap time
Bring diapers for diaper changeBring bottle for comfortingBring pacifier, if usedBring familiar car seat for test
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Manage Baby/Mom/Diagnostic Manage Baby/Mom/Diagnostic EnvironmentEnvironment
Quietest environment possible, no talking, no noisy toys
Reduce undesirable visual, auditory, tactile distractions
calm, alert child preferred, but not after heavy feeding, will fall asleep
Do not separate child from parent and create crying, agitated child
Wait for child to calm prior to initiating test
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Child/Parent Handling IssuesChild/Parent Handling Issues Child State
Activity levelComfort level
Infection controlClinic protocol
Gloves, disposables, cross contamination Parent inclusion
Pre-test information sharingTime during testingTime spent informing about procedureInforming about the results
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Visual Reinforcement AudiometryVisual Reinforcement Audiometry
Developmentally appropriate technique that gives valid estimate of hearing
Gives ear specific, frequency specific information Reliable method for early years Practical for repeat use
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Schedule for Behavioral Schedule for Behavioral Audiological AssessmentAudiological Assessment
Visual Reinforcement Audiometry scheduled at 7,12, 18, and 24 month follow-up visits
Play Audiometry scheduled at 24, 30, 36, 42, and 42 month
follow-up visit
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VRA Assessment InformationVRA Assessment Information
Beginning stimulus type warble tone, speech
Beginning transducerearphone, speaker# beginning conditioning trials# reconditioning trials# stimulus trials# control trials, if greater than 0, #
correct
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VRA VRA AssessmentAssessment Information Information Test time Number of breaks taken DPs completed, 2,3,4,6,and 8 Acoustic Immittance Measures Done?
Acoustic reflex threshold tympanometry
Follow up/ reschedule, no, yes- mark reason Fussy scared, wax occluding canal, time, refused
earphones/inserts, habituated, test reliability poor, failed to condition, mrl > 20, cnd if sn loss present, other- specify
Medical Follow-up Recommended- yes, no- mark reason Conductive component, tymps abnormal, ab gap,
draining ear, hearing aid clearance
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Visual Reinforcement Visual Reinforcement AudiometryAudiometry
Affix study id label, site initials, al, ms, nj, nc, oh, pa, tx Record ideal visit month according to protocol Record sequence number, 1 for first test in ideal month
sequence, sequence number of repeat assessments required to obtain complete assessment data
Was VRA testing done Date of assessment Minimal threshold level for each frequency
Lowest threshold level 999 frequency not tested 555 could not determine 888 tested, but no response
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VRA at Follow Up Visits at VRA at Follow Up Visits at 8, 12, 18, and 24 Months of Age8, 12, 18, and 24 Months of Age
Optimal goal: obtain pure tone minimum response level of 15 dB HL at 0.5, 1.0, 2.0, and 4.0 kHz
If MRLs elevated above 20 dB HL, tymps and/or bc will be needed to distinguish between sn, cond. Or mixed loss
Record VRA data on CF108 If immittance is administered, record data on CF110 Minimal goal: Obtain MRLs at 0.5, 2.0, and 4.0 kHz If MRLs elevated above 20 dB HL, administer tymps
and/or bc If MRLs for Minimal goal can not be obtained, schedule
up to 3 additional visits and report any valid data collected using sequenced numbered data forms: visit 1, 2, or 3, for 8 month data
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Visual Reinforcement Visual Reinforcement AudiometryAudiometry
Optional, 8000 hz and speech awareness threshold, record if obtained
Bc not required, leave field blank
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VRA Protocol (Widen)VRA Protocol (Widen) Pulsed, FM Tones, 1-2 sec. Duration, LV speech at 35 dB unconditioned, 2 responses naturally go to test
protocol 35 dB no response, go to 55 dB If no response, go to conditioning at higher level Training - pair the reinforcer with stimulus at 55 dB, 2 chances
then go to probe with reinforcement presented with correct head turn response, do second correct probe trial, then TEST
If training does not work at 55 dB, go to 75 dB and repeat process
Use down 20 dB, up 10 dB in TEST mode in first reversal, then down 10 up 5 thereafter
Next frequency, begin at level of previous response MRL – lowest level with 2 responses out of 3
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Ensuring Stimulus Control For Ensuring Stimulus Control For Behavioral ResponsesBehavioral Responses
Control trials - observation intervals in which no stimulus was present, but examiner notes head turn behavior and no reinforcement provided to ensure head turn linked to stimulus presentation (inserted at a rate of 25%) >30%, test validity ???
Probe trials - stimulus presentations at suprathreshold levels used to confirm conditioning at beginning and throughout session
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When Child Does Not When Child Does Not ConditionCondition
Change ear Change stimulus type- another frequency
or speech Mode of presentation change – sound
field Change reinforcer, strength of video
reinforcer not strong enough Take a 10 minute break
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Play Audiometry Data FormPlay Audiometry Data Form Complete at 24, 30, 36, 42, and 48 month follow up
visits Complete Header
Affix study id label, complete site id with state initials Was testing done- yes, no give reason, Parental refusal, late for apt, missed slot,
uncooperative, would not participate Date of audiology evaluation – mm/dd/yy Minimal threshold level, enter lowest threshold for
each freq. for each ear.Could not test, enter 555Was not tested, enter 999Was tested, no response , enter 888
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Play Audiometry Data Form Play Audiometry Data Form (2)(2)
Optional – if 12 kHz or speech recognition threshold (SRT) were obtained, enter otherwise, leave blank
Primary Language of household Dps completed Acoustic immittance measures completed Follow up/reschedule, specify reason Medical follow up recommended, specify
reason
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Looks Good, But…….Looks Good, But…….
Visual alerting by examiner can give normal audiogram for child who is deaf
Results may look confusing, but be accurate, evaluate carefully Hearing is dynamic, does not necessarily stay the same, be alert to progression Use all sources of information
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Contact the CHIMES StudyContact the CHIMES Study
www.uab.edu/chimesstudy
Karen Fowler [email protected]