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CHIMES STUDY: CONGENITAL CYTOMEGALOVIRUS INFECTION AND HEARING MULTICENTER SCREENING STUDY. Karen Fowler, DrPH University of Alabama in Birmingham Faye P. McCollister, EdD University of Alabama, Emeritus Diane Sabo, PhD University of Pittsburgh.

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chimes study congenital cytomegalovirus infection and hearing multicenter screening study
CHIMES STUDY: CONGENITAL CYTOMEGALOVIRUS INFECTION AND HEARING MULTICENTER SCREENING STUDY

Karen Fowler, DrPH

University of Alabama

in Birmingham

Faye P. McCollister, EdD

University of Alabama, Emeritus

Diane Sabo, PhD

University of Pittsburgh

confusion regarding congenital cmv infection hearing loss
Confusion Regarding Congenital CMV 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
slide3

Review of Congenital CMV Infection

  • 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 and hearing loss research
Review of Congenital CMV and Hearing 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

slide5

NIH/NIDCD Contract

The Natural History of CMV-Related Hearing Loss and the Feasibility of CMV Screening as Adjunct to Hearing in the Newborn

nidcd cmv grant uab
NIDCD 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
slide8

Project Design

  • 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)
slide9

Objectives

  • 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 newborn
    • in the prediction of hearing impairment with onset during infancy or in the early years of life
project staff
Project 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
site audiologists
Site 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
slide12

Participating Hospitals

Birmingham, AL

University Hospital & Cooper Green Hospital

Jackson, MS

University of Mississippi Medical Center

New Brunswick, NJ

Saint Peters University Hospital

Charlotte, NC

Carolinas Medical Center

Cincinnati, OH

Good Samaritan Hospital

Pittsburgh, PA

Magee Women’s Hospital

Dallas, TX

Parkland Memorial Hospital

slide13

Selected Hospital Populations

38% Caucasian, Non Hispanic

34% Caucasian, Hispanic

24% African American

4% Asian

challenges to the chimes study 1
Challenges to the CHIMES 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
challenges to the chimes study 2
Challenges to the CHIMES 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
challenges to the chimes study 3
Challenges to the CHIMES 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
addressing the challenges to the chimes study
Addressing the Challenges 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
subject variables
Subject Variables
  • Additional Disabilities (symptomatic infection)
    • Vision
      • Can not see visual reinforcers
      • Can not process visual instructions
      • Need glasses for assessment, if prescribed
    • Seizure disorder
      • Flicker stimulation with lighted reinforcer
      • Absence, petit mal, and grand mal seizures
cultural diversity
Cultural 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
cultural diversity22
Cultural 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.
chimes study23
CHIMES STUDY

Audiological Assessment

Protocol

Diane Sabo, PhD

University of Pittsburgh

components of study audiological assessment
Components of Study Audiological 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 assessment
    • VRA
    • Play
screening data obtained
Screening Data Obtained
  • Physiologic data
    • ABR
    • Automated-ABR
    • OAEs
    • Automated OAEs
    • Combinations of the tests
objective hearing diagnostic methods
Objective Hearing Diagnostic Methods
  • 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)
entry or baseline data
Entry or Baseline Data
  • Physiologic tests
    • ABR
      • Tone bursts at .5, 1, 2 and 4k Hz
      • Bone conduction if air conduction abnormal (>25)
    • DPOAEs
      • 2-8k Hz
      • 60/45
      • Signal and noise levels recorded
physiologic assessment with abr and eoaes
Physiologic Assessment with ABR and EOAEs
  • Advantages
    • “Objective”
    • Reliable
    • Correlate well with hearing
    • Age not a factor (but sometimes an issue)
physiologic assessment with abr and eoaes29
Physiologic Assessment with ABR and EOAEs
  • Limitations
    • Not completely “objective”
    • Not tests of hearing
    • Not always good at predicting threshold
    • Not independent of infant’s behavior, state, or other factors
click spectrum
Click Spectrum

Frequency

Frequency

what we know about abr clicks
What We Know About ABR Clicks
  • Click commonly used, but……can give misleading information
    • Click has energy at all frequencies transduced by earphone
    • Within 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
abr assessment at enrollment visit
ABR Assessment at Enrollment 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 report
      • Otoscopic inspection
      • DPOAE
        • Medical referral if testing deferred because of otologic problems
physiologic assessment with abr and eoaes36
Physiologic Assessment with ABR and EOAEs
  • Advantages
    • “Objective”
    • Reliable
    • Correlate well with hearing
    • Age not a factor (but sometimes an issue)
optimal goal for abr assessment at enrollment visit 3 6 weeks
Optimal Goal for ABR Assessment at 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
minimal goal for abr assessment at enrollment visit at 3 6 weeks of age
Minimal Goal for ABR Assessment at Enrollment Visit at 3-6 Weeks of 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
abr protocol
ABR 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
abr parameters
ABR 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
entry data
Entry Data
  • Acoustic Immittance Data
    • Tympanometry
      • High frequency tymps (1k) < 7 months
    • Acoustic reflex thresholds
      • IPSI reflexes @ 1k only, if necessary
use insert earphones
Use 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
chimes study43
CHIMES STUDY

Faye P. McCollister, EdD

University of Alabama, Emeritus

Behavioral Audiological

Assessment Protocols

request parental help in preparing for behavioral diagnostic assessment
Request Parental Help in Preparing for Behavioral Diagnostic Assessment
  • Try to have child rested and feed, comfortable and attentive for test
  • Schedule appointment away from nap time
    • Bring diapers for diaper change
    • Bring bottle for comforting
    • Bring pacifier, if used
    • Bring familiar car seat for test
manage baby mom diagnostic environment
Manage Baby/Mom/Diagnostic Environment
  • 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
child parent handling issues
Child/Parent Handling Issues
  • Child State
    • Activity level
    • Comfort level
  • Infection control
    • Clinic protocol
      • Gloves, disposables, cross contamination
  • Parent inclusion
    • Pre-test information sharing
    • Time during testing
    • Time spent informing about procedure
    • Informing about the results
visual reinforcement audiometry
Visual 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
schedule for behavioral audiological assessment
Schedule for Behavioral Audiological 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

vra assessment information
VRA Assessment Information
  • Beginning stimulus type
    • warble tone, speech
  • Beginning transducer
    • earphone, speaker
    • # beginning conditioning trials
    • # reconditioning trials
    • # stimulus trials
    • # control trials, if greater than 0, # correct
vra assessment information50
VRA Assessment 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
visual reinforcement audiometry51
Visual Reinforcement Audiometry
  • 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
vra at follow up visits at 8 12 18 and 24 months of age
VRA at Follow Up Visits at 8, 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
visual reinforcement audiometry53
Visual Reinforcement Audiometry
  • Optional, 8000 hz and speech awareness threshold, record if obtained
  • Bc not required, leave field blank
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
ensuring stimulus control for behavioral responses
Ensuring Stimulus Control For Behavioral 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
when child does not condition
When Child Does Not Condition
  • 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
play audiometry data form
Play 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 555
      • Was not tested, enter 999
      • Was tested, no response , enter 888
play audiometry data form 2
Play Audiometry Data Form (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
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
contact the chimes study
Contact the CHIMES Study
  • www.uab.edu/chimesstudy

Karen Fowler kfowler@uab.edu