Download The High-Risk Factors for hearing loss - Clinical Trials Registry

To,
The Member Secretary
Ethics committee,
Nazareth Hospital, Shillong
Subject: Submission of Research Protocol for Ethical Clearance
Sir/Madam,
I am hereby submitting a copy of the research protocol titled “Universal Newborn
Hearing Screening in a Tertiary Health Centre in North East India”, in the fulfillment for
conducting a research, for ethical clearance. It has been check and approved by the
other co-investigator in the project.
Thanking you.
Yours Sincerely,
Dr Henry B. Nongrum
Consultant
Department of Otolaryngology and Head & Neck Surgery
Nazareth Hospital
Shillong.
1
RESEARCH PROTOCOL
Department of Otolaryngology and Head & Neck Surgery,
Nazareth Hospital, Shillong
Title of the study:
Universal Newborn Hearing Screening in a Tertiary Health
Centre in North East India
Name of Principal
Investigtor;
Dr Henry Benson Nongrum (MS),
Consultant
Department of Otolaryngology and Head & Neck Surgery
Name of SubInvestigator:
Dr Santanu Deb (MD)
Consultant and Head of Department,
Department of Pediatrics, Nazareth Hospital, Shillong
Dr Palash R. Gogoi (MD)
Consultant, Department of Pediatrics,
Nazareth Hospital, Shillong
Dr Prasanjit Paul (Dch)
Consultant, Department of Pediatrics.
Nazareth Hospital, Shillong
Dr Indrani Roy (MD)
Consultant and Head of Department
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Dr Alok Deb (DGO)
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Dr Deborah Dkhar (DGO)
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
2
Dr Talitha Dkhar (DGO)
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Dr Star Pala (MD)
Assistant Professor
Department of Community Medicine
North Eastern Indira Gandhi Regional institute of Health and
Medical Sciences (NEIGRIHMS), Shillong
Lalhmangaihi Pachuau (MSc Audiology)
Audiologist and Speech Therapist
Nazareth Hospital, Shillong
Cost involved (appx.
In Rs.)
Who will bear the cost
the cost?
200 for General ward and 300 for private ward per patient.
1. Patient
2. Project
3. Exempted
Patient information
Sheet (mark if yes)
English
Khasi
Certified that the khasi version is a true translation of
the English version
Whether any work on
this project has started
or not
Yes
No
Attached Documents
1. Consent form
2. Patient information sheet
Date of Submission
of Research Protocol
3
RESEARCH PROTOCOL
Universal Newborn Hearing Screening in a Tertiary Health Centre in North East
India
Principal Investigator:
Dr Henry Benson Nongrum (MS)
Consultant
Department of Otolaryngology and Head Neck Surgery
Sub-Investigator:
Dr Santanu Deb (MD)
Dr Palash Gogoi (MD)
Consultant and Head of Department,
Department of Pediatrics
Nazareth Hospital, Shillong
Consultant, Department of Pediatrics
Nazareth Hospital, Shillong
Dr Prasanjit Paul (Dch)
Dr Indrani Roy (MD)
Consultant, Department of Pediatrics.
Nazareth Hospital, Shillong
Consultant and Head of Department
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Dr Alok Deb (DGO)
Dr Deborah Dkhar (DGO)
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Dr Talitha Dkhar (DGO)
Lalhmangaihi Pachuau(MSc Audiology)
Consultant
Department of Obstetrics and gynaecology
Nazareth Hospital, Shillong
Audiologist and Speech Therapist
Nazareth Hospital
Dr Star Pala (MD)
Assistant Professor
Department of Community Medicine
North Eastern Indira Gandhi Regional
institute of Health and Medical Sciences Shillong
(NEIGRIHMS), Shillong
4
INTRODUCTION
It is generally recognized that unidentified hearing loss has affected many children in
their social-emotional development as well as their academic performance. Hearing loss
in a child was always detected late well beyond the newborn period and many a times
until the school age. But with the development of new technologies, in the late 1980s,
Dr. C. Everett Koop, then U.S. Surgeon General, encouraged that detection of hearing
loss be included in the Healthy People 2000 goals for the nation 1.
Since then there is
an increasing acceptance in many countries regarding the hearing screening of
newborn. Studies have shown that congenital hearing loss is one of the common
congenital anomalies, occurring in 1 to 2 infants per 1000 life birth 2. The prevalence of
hearing loss has been shown to be greater than that of most other diseases and
syndromes screened for at birth (eg, phenylketonuria and sickle cell disease). The
incidence of hearing loss is considerably higher in infants in the NICU (1–2 cases per
200 infants; 1.9% bilateral and 0.6% unilateral3.
It is realized that the negative effects of congenital hearing loss can be diminished and
even eliminated through early intervention at or before 6 months of age 4.
With the advancement of technologies reliable screening test have become available
which are highly sensitive in detecting even mild hearing loss.
Thus, early detection of hearing loss in children has been a long standing clinical priority
in the field of Audiology because language and communication serve as the foundation
for normal child development, delays in the acquisition of these skills affect literacy,
academic achievement, and social and personal development. Ultimately, the earlier
5
detection occurs, the earlier intervention can begin, thereby increasing the likelihood of
optimizing a child’s potential in all developmental areas
6
REVIEW OF LITERATURE
HISTORICAL BACKGROUND
The earlier proponent of early detection of hearing loss in a child was provided by
the Joint committee on Infant Hearing (JCIH)5, who had endorsed a high risk register
(HRR) for selecting infants who should receive hearing evaluation. However, this
resulted in identification of only about 50% of infants with sensory neural hearing loss.
With the widespread implementation of Universal Newborn Hearing Screening (UNHS),
the JCIH6 revised the risk indicators for neonates where universal screening is not yet
implemented. Any infant with the risk indicators who had passed the birth screen
should, nonetheless, receive audiological monitoring every 6 months until 3 years of
age.
The goal of universal neonatal hearing screening (UNHS) is to maximize linguistic and
communicative competence and literacy development for children who are hard of
hearing or deaf. Bess et al.7 challenged the need for earlier identification and
intervention, stating that no evidence support the notion "that outcomes in children with
congenital hearing loss are more favorable if treatment is begun early in infancy rather
than later in childhood." This statement was however refuted by many, and several
authors have proven a higher language score, vocal communicative, linguistic skills
when hearing loss was detected earlier and rehabilitated at the earliest. The difference
in the performance was significantly different when hearing loss was detected below 2
and after 2 months of age8,9,10,11. It is also demonstrated that even children identified as
early as age 7-12 months had lower receptive and expressive language quotients than
those of children identified by age 6 months. No significant difference was found
7
between children identified at age 7-12 months and those identified at age 25-30
months11.
So, the importance of early identification and intervention has been clearly
demonstrated. Identification and intervention before age 6 months can have a
significant impact on the development of expressive and receptive language. The
finding that language scores were not significantly different between the children
identified later truly establishes the critical period of early identification and intervention
to be within the first 6 months of life.
Prevalence and Incidence
Retrospective studies of large universal newborn hearing screening programs have
shown that permanent hearing loss is one of the most common abnormalities present at
birth. The World Health Organization (WHO) in 1998 estimated 123 million people in the
world with a hearing loss of 41 dB or more, in the better ear, and a majority of them
were living in Asia. The prevalence of hearing loss is approximately 1 to 3 per 100
newborns in well baby nursery population compared to 2 to 4 per 1000 infants in the
intensive care unit population12. A retrospective study conducted by Connolly et al,
found that 1 of every 811 infants without risk factors and 1 of every 75 infants with risk
factors have hearing loss13.
There are various studies from the United States showing the prevalence of hearing
loss in Newborns as:
8
Investigator, Year
Connolly13,
State
2005 Mississippi
Rate of Hearing Loss
1.00/
811
(no
risk)
Study Population
17,602
1.00 / 75 (high risk)
Finitzo14,
1998 Texas
3.14 / 1000
54,228
Vohr15,
1998 Rhode Island
2.00 / 1000
53,121
Downs16,
1995
3.20 / 1000
14,404
Colorado
Surveys from India in 1986, shows a deaf population of 3.02 million and in 1991the
population increase and stated that 3.24 millions deaf population are between the age
group of 5 -14 years17. However the report of 1999 survey estimated a 0.3 million
hearing impaired population between 0-4 years age group and 1.5 million in the age
range of 5-12 years18.
Surprisingly, no dedicated national programme has been carried out so far, in India, for
early detection of hearing loss in newborns. The prevalence and incidence rate in India
is quite alarming. Very few studies were conducted in India to suggest the prevalence
and incidence of hearing loss in newborns. Nagapoornima et at. extrapolated the
incidence of hearing loss in newborns as 5.60 per 1000 screened. They showed an
incidence of 5.65 per 1000 screened amongst the not at risk newborns, whereas 10.70
per 1000 screened when risk factors were associated19.
The prevalence of hearing loss may continue to change as more data becomes
available from universal newborn hearing screening programs.
9
The High-Risk Factors for hearing loss
Prior to the implementation of universal newborn hearing screening, only infants
identified as being at high risk for hearing loss on the basis of the high-risk register
(HRR) were routinely screened. According to the Joint Committee on Infant Hearing
Position Statement20, the risk factors for newborns are as follows:

Family history of permanent childhood sensorineural hearing loss

In utero infection such as cytomegalovirus, rubella toxoplasmosis, or herpes

Craniofacial anomalies, including those with morphological abnormalities of the
pinna and ear canal

Neonatal indicators, specifically hyperbilirubinemia at a serum level requiring
exchange transfusion, persistent pulmonary hypertension of the newborn (PPHN)
associated with mechanical ventilation, and conditions requiring the use of
extracorporeal membrane oxygenation (ECMO)

Postnatal infections associated with sensorineural hearing loss, including bacterial
meningitis

Stigmata or other findings associated with a syndrome known to include a
sensorineural or conductive hearing loss or eustachian tube dysfunction

Syndromes associated with progressive hearing loss such as neurofibromatosis,
osteopetrosis, and Usher syndrome

Neurodegenerative disorders, such as Hunter syndrome, or sensory motor
neuropathies, such as Charcot-Marie-Tooth syndrome

Parental or caregiver concern regarding hearing, speech, language, and/or
developmental delay
10

Head trauma

Recurrent or persistent otitis media with effusion lasting for at least 3 months
However the use of the HRR as the primary indicator for screening of newborns for
hearing loss was inadequate. Finitzio et al.21 reported that, approximately 8,000-16,000
newborns are born with hearing loss each year. Of these, 50% are discharged home
from the well-baby nursery with no known risk factors for hearing loss, according to the
National Institutes of Health (NIH). Although these risk factors should not be ignored, a
program in which only neonates meeting the HRR criteria are screened was found to
exclude as many as 50% of newborns with significant congenital hearing loss.
An updated HRR is still used to identify children who are at risk for hearing loss. All
newborns should be screened, regardless of risk. If a newborn passes the newborn
hearing screening but has an identified risk for sensorineural and/or conductive hearing
loss, these infants should be closely monitored for any changes in hearing status. Many
states in the United States recommend that at-risk children should be evaluated by an
audiologist every 6 months for the first 3 years of life. This helps to quickly identify
hearing status changes so that intervention can occur; limiting any impact the hearing
loss has on speech and language development.
Methods of screening
Physiologic measures must be used to screen newborns and infants for hearing loss.
Such measures include Oto Acoustic Emision (OAE) and Auditory Brainstem Response
(ABR) testing. Both OAE and ABR technologies provide noninvasive recordings of
11
physiologic activity underlying normal auditory function, both are easily performed in
neonates and infants, and both have been successfully used for UNHS 14,15.
(i)
Oto Acoustic Emission (OAE)
OAEs are used to assess cochlear integrity and are physiologic measurements of the
response of the outer hair cells to acoustic stimuli. They serve as a fast objective
screening test for normal preneural cochlear function. To measure OAEs, a probe
assembly is placed in the ear canal, tonal or click stimuli are delivered, and the OAE
generated by the cochlea is measured with a microphone.
Currently, two types of evoked OAE measurements are used for newborn hearing
screening: transient evoked otoacoustic emissions (TEOAEs) and distortion product
otoacoustic emissions (DPOAEs). Provided that the patient's middle ear function is
normal, these measurements can be used to assess cochlear function for the 500-6000
Hz frequency range. The presence of evoked OAE responses indicates hearing
sensitivity in the normal to near-normal range.
OAEs are fast, efficient, and frequency-specific measurements of peripheral auditory
sensitivity. However, the effectiveness of the test is reduced by contamination with lowfrequency ambient noise in a busy nursery, vernix in the ear canal, or any middle ear
pathology.
(i)
Auditory Brainstem Response
In contrast, ABR measurements are obtained from surface electrodes that record
neural activity generated in the cochlea, auditory nerve, and brainstem in response to
acoustic stimuli delivered via earphones. The ABR is not used to assess hearing in a
12
perceptual sense; rather, it helps in evaluating the integrity of the peripheral auditory
system from which estimates of hearing can be derived.
Auditory brainstem response (ABR), otoacoustic emissions (OAEs), and automated
ABR (AABR) testing have all been used in newborn hearing-screening programs. For
20 years, manual or diagnostic ABR testing has been a reliable means of assessing
auditory function from the eighth nerve through the auditory brainstem. A modified
screening version of the ABR test, called the AABR test, has been available for
screening since approximately 1987. The 2 methods used in most universal hearingscreening programs are automated OAEs and AABR. The AABR methods produces a
simple pass or fail result without requiring interpretation and the test can be conducted
in the presence of background noise. However, it lacks frequency-specific information
and requires increased preparation time prior to testing.
Both OAE and ABR are used as a screening tool and are sensitive in detecting sensory
(cochlear) hearing loss22. ABR is the however the method of choice for hearing
screening in infants less than 5 months of age, as it does not require child participation
and can be done without sedation23. However both technologies may be affected by
outer or middle ear dysfunction. Consequently, transient conditions of the outer and
middle ear may result in a ‘fail’ screening test result in the presence of normal cochlear
and/ or neural function24. Moreover, because OAEs are generated within the cochlea,
OAE technology cannot be used to detect neural (eight nerve or auditory brainstem
pathway) dysfunction. Thus, infants with neural conduction disorders or auditory
neuropathy/dyssynchrony without concomitant sensory dysfunction will not be detected
by OAE testing6.
13
OAE represents a quick, cost effective and a valid method of testing cochlear function,
though ABR is a more sensitive and specific test, therefore there are proponent of
utilizing OAE for screening and confirm the presence of hearing loss with ABR if a child
fails a second OAE screen25.
The sensitivity and specificity of OAE is as a screening tool varies between 95 – 100%
and 75 – 85%26,27,28, whereas that for ABR is 97 -100% and 96 -98% 29,30,respectively.
Some author prefers ABR to OAE for screening, but considering the ease, cost
effectiveness and practicability first screening with OAE may be preferred to ABR. From
the various studies conducted performing a first screen with OAE followed by a second
stage screen with ABR (in those who failed the first screen) have shown to have a
sensitivity and specificity approaching 100% in detecting hearing loss and also the
likelihood of obtaining a pass outcome by chance alone is increased when screening is
performed repeatedly. This is also a recommended approach for universal newborn
hearing screen31,32,33,34,35,36.
In view of a high incidence of auditory neuropathy/dyssynchrony amongst newborn
admitted in Neonatal Intensive Care Unit (NICU), where OAE may be normal but with
an abnormal ABR, therefore ABR is recommended as an appropriate screening tool 37.
Follow-up testing
Infants who do not pass an initial hearing screening at birth should return for follow-up
testing within 1 month. This follow-up allows for multiple testing sessions, medical
intervention, parent counseling, and appropriate amplification measures to be initiated
before the age of 6 months. The goal for identification and intervention by 6 months is
important for language development, and diagnosis before this critical age can prevent
14
the need for sedation37. As the age of an infant increases, the ability to obtain a full
diagnostic test battery decreases. If follow-up is delayed, sedation may be required in
order to obtain electrophysiological measures.
Diagnostic OAE and ABR testing is recommended for any infant who does not pass the
second screening session. Both tests are necessary to differentially diagnose an infant's
hearing impairment. OAE tests are used to assess the outer, middle, and inner ear
portions of the auditory system. ABR testing helps in assessing the whole system, from
the periphery to the auditory nerve and brainstem 37.
Aetiology:
Congenital hearing loss is attributed to various causes which may be pre, peri and post
natal factors. This therefore demands for a thorough history taking and clinical
examination for all newborns undergoing the screening test. Declau et al38 identified
etiologic factors in 55.2% of the cases referred after failed screening. Of the causes
identified, a genetic mechanism was present in 60.4% of the cases, peripartal problems
in 20.8%, and congenital cytomegalovirus infection in 18.8%.
Figure. Etiologic diagnosis for children with congenital permanent hearing loss (Declau et al. 2008).
15
Hearing impairment can be genetic (inherited) or non-genetic. Non-genetic causes
include illness or injury before, during or after birth. In some cases, the cause of hearing
impairment is not known. About 90 percent of babies with congenital hearing
impairment
are
born
to
parents
with
normal
hearing39.
Genetic factors are believed to cause 50 percent of cases of hearing impairment in
infants and young children. Scientists believe that mutations (changes) in as many as
400 genes may contribute to hearing impairment40
Genetic causes of hearing impairment can be:
Syndromic: Syndromic means that the hearing impairment happens with a specific
group of birth defects. It’s not the only birth defect a baby has. This type of hearing
impairment accounts for about 30 percent of genetic cases39,40.
Non-syndromic: Non-syndromic means that hearing impairment is the only birth defect
a baby has. About 50 percent of cases of non-syndromatic genetic hearing impairment
are caused by a mutation in a gene called connexin 2640.
As per these studies, about 25 percent of cases of hearing impairment are caused by
non-genetic factors. These include premature birth (before 37 completed weeks of
pregnancy) and illnesses during pregnancy, such as:

Rubella (German measles)

Cytomegalovirus infections

Toxoplasmosis

Herpes infection

Syphilis
Non-genetic causes of hearing impairment after birth include:
16

Head injuries

Childhood infections (such as meningitis, measles or chickenpox)

Certain medications (such as the antibiotic streptomycin and related drugs)

Ear
infections
(otitis
media) – These
usually
cause
temporary
hearing
impairment. However, frequent and poorly treated ear infections can cause permanent
hearing impairment.
The causes of the remaining 25 percent of cases of hearing impairment in infants
and children are unknown.
Study done on children with cleft lip and palate shows abnormal BERA on 78% of the
children with cleft palate having ABR thresholds of greater than 30dBnHL in at least one
ear, however 70% of the children showed elevated thresholds in both the ears. 4%
presented with a sensory neural hearing loss41.
Amongst the non-genetic cause of sensorineural hearing loss, Cytomegalovirus
infection have been shown to be a major attribution 42,43,44. Congenital abnormalities of
the head and neck and birth asphyxia were the strongest predictors of conductive
hearing impairment, outshooting family history which was the cause for the largest
number of referrals45. Whereas hyperbilirubinemia appears to be the most prevalent
factor causing sensory neural hearing loss outnumbering other common risk factors like
anoxia, family history etc. (see table below)46.
17
Table. Shows the relation between etiology and the type of loss
18
AIMS AND OBJECTIVES
1. To assess the incidence of congenital hearing loss amongst newborn delivered in a
tertiary health centre in Shillong.
2. To find out the associated etiological factors of congenital hearing loss in Newborn.
METHODS
Study Design:
Cohort Study
Inclusion Criteria:
All newborn in the hospital including those born elsewhere
(desiring evaluation of hearing status).
Exclusion Criteria:
Refusal for screening / not consented
Auditory canal deformities like microtia (type II onwards)
Study Duration:
2years.
Setting:
Nazareth Hospital, Shillong.
PROCEDURE:
The team of the hearing screening includes a Pediatrician, Otorhinolaryngoloist,
Gynecologist, Audiologist, Staff nurses, Statistician, Counselor and a computer typist.
Hearing screening Test is carried out by an audiologist. A written informed consent is
taken after explaining the need and importance of the test, procedure, the possible
outcome and the cost for the test.
Detailed recordings are made for all babies regarding demographic information,
birthweight, gestational age, prenatal, perinatal, post natal details, clinical examination,
19
examination of the ear, nose and throat, hematological and biochemical reports are
noted, use of ototoxic drugs, NICU admission, phototherapy etc. as shown in the below
proforma.
The babies will be divided into two groups: 1) Not at risk and 2) High Risk babies
(as defined in the above review of literature).
Preparation before screening:
At the time the child is delivered, the external auditory canal is gently cleaned
with a swab to remove the liquor/amniotic fluid which will make the initial screening
much more effective.
In case of neonates, if the baby does not sleep during the test they are breast fed
and once they go to sleep the test can be performed. In case the child does not sleep,
the child is sedated with syrup promethazine (Phenargan) at the dose of 5ml for every
10kg or in consultation with the pediatrician. In this case the pediatrician is kept inform
in case of any on-toward incidence. But as far as possible all efforts are made not to
give any sedation to the child.
The Room temperature is maintained at 24o to 30o depending upon the
environmental condition. But all precaution is taken to avoid hypothermia to the child.
Screening Methodology (fig 1):
All babies included in the screening protocol, who are not at high risk, will be
initially screened with Oto-Acoustic Emission (OAE). If they fail the initial screen, they
will be called back for a repeat screen at after two months. The second screen will again
be done with OAE. If they fail the second screen, Brain Stem Evoked Auditory
Response (BERA) will then be done to confirm the hearing loss.
20
In the case of a high-risk babies (define in the above review of literature), the
initial screening will be done by both OAE and BERA. In case the child fails BERA, the
test will be repeated after two months with BERA only. The intention here is to detect
the presence of suspected auditory neuropathy and to confirm hearing loss.
If the child fails the screening test, the child will be subjected to further
confirmation
using
Behavioural
Observational
Audiometry
(BOA),
Impedance
audiometry and Reflex audiometry, before the child is planned for rehabilitation.
In case of a low birth weight neonate, where the ear canal is too small and the
ear tip cannot be snugly fitted into the canal, these neonate are ask to come for
screening between 2weeks and 1 month, till the child grows enough to enable the
audiologist to fit in the ear tip.
In case a child fails the screening test, the counselor explains the condition of the
child and convinces the parents to bring back the child for a repeat screen. All efforts
will be done to complete the screening between 3 – 6 months of age.
Rehabilitation Methodology:
On detection of any hearing loss of any degree, the infant will be subjected to
rehabilitation initially with Hearing Aids (which is the standard of rehabilitation). The
infant will be assessed at regular interval to assess the improvement in response with
hearing aid rehabilitation. The aim is to start the rehabilitation as early as 6 months of
age. For those infants who show good response, the parents will be counseled for
rehabilitation with cochlear implant (depending on the response and affordability).
21
OPERATIONAL DEFINITION:
1. Measurement of transient evoked otoacoustic emissions (TEOAEs)
All babies are first screened using an Intelligent Hearing Systems (IHS, Miami,
Florida) Smart TrOAE which involves placing a probe into the baby’s outer ear. This test
concentrates on the main speech frequency band range of
1 to 4 KHz. A “Pass Screening’’ response is based on detecting a non-linear TEOAE
cross correlated signal-to-noise ratio of at least 3 decibels (dB) on at least 3 frequencies
out of the 5 frequencies tested. And for a “Pass Diagnostic” signal- to noise ratio of at
least 6 dB on at least 4 frequencies out of the 5 are required. The test stimulus is 80dB
SPL click at the rate of 19/sec with a total sweep of 1024.
"Refer" outcome during the various stages of screening in particular are not
presented as evidence of hearing loss but rather as indication that further tests are
required to rule out any uncertainty regarding the hearing status of the child.
2. Brainstem Evoked Auditory Responses (BERA) or Auditory Brainstem
Response (ABR):
The detection of ABR is more specific, but the test is more time consuming than
the TEOAE screen, requiring the placement of scalp electrodes after carefully cleaning
the baby’s forehead and mastoid region. A gentle abrasive skin preparing gel ( NuPrep)
is used to clean the skin. A Ten20 conductive EEG Paste is used to attach the Gold cup
electrodes on the sites enforced with Transpore surgical tapes. Foam insert ear tips are
used to deliver the signal to the ear. The ABR instrument used is the Intelligent Hearing
Systems (IHS, Miami, Florida).
22
A click stimulus is delivered at 60 dB and if responses are recorded, a 40 dB
recording is repeated. If there is a no identifiable response at 60 dB, the intensity is
increased to 80 dB. Auditory brainstem response is a modified electroencephalogram
recording of brain activity in response to auditory stimuli presented in the form of brief
clicks. By averaging techniques, the electrical potential can be detected and used to
determine the hearing threshold.
Fig1. Screening methodology
(OAE-Otoacoustic emission, BERA – BrainStem Evoke Response Audiometry,
BOA-Behavioral Observational Audiometry, I/A-Impedance Audiometry)
23
Study Finances
Presently there are no funding sources for the research project. The Subject will have to
pay a nominal charge of Two hundred to Three hundred rupees only (necessary for the
maintenance of instruments and other requirements). However in case the subject
cannot afford to make the necessary payments, on behalf of the hospital, the charges
will be waived off in order to avoid missing out on the screening. However any time later
when funding sources are available, this will be intimidated to the Institutional Ethics
Committee and the necessary action are taken.
24
REFERENCES
1.
U.S. Department of Health and Human Services, Office of Disease Prevention and
Health Promotion. (1991). Healthy People 2000: National health promotion and
disease prevention objectives. Washington, DC: U.S. Government Printing Office.
Retrieved January 24, 2007, from
http://odphp.osophs.dhhs.gov/pubs/hp2000/hppub97.htm.
2.
Parving A, Hauch AM, Christensen B. Hearing loss in children: epidemiology, age
at identification and causes through 30 years [in Danish]. Ugeskr Laeger. 2003; 165
(6): 574- 579.
3.
Van Straaten HL, Tibosch CH, Dorrepaal C, Dekker FW, Kok JH. Efficacy of
automated auditory brainstem response hearing screening in very preterm
newborns. J Pediatr. 2001;138(5): 674–678
4.
Yoshinaga-Itano C, Coulter D, Thomson V. Developmental outcomes of children
with hearing loss born in Colorado hospitals with and without universal newborn
hearing screening programs. Semin Neonatol. 2001;6(6):521–529
5.
Joint Committee on Infant Hearing (JCIH). Supplementary statement on infant
hearing screening. ASHA. 1972; 16, 160.
6.
Joint Committee on Infant Hearing (JCIH). Year 2000 position statement: principles
and guidelines for early hearing detection and intervention programs. American
Journal of Audiology. 2000; 9: 9- 29.
7.
Bess FH, Paradise JL. Universal screening for infant hearing impairment: not
simple, not risk free, not necessarily beneficial, and not presently justified.
Pediatrics. Feb 1994; 93(2):330-4.
25
8.
White SJ, White RE. The effects of hearing status of the family and age of
intervention on receptive and expressive oral language skills in hearing-impaired
infants. ASHA Monogr. Oct 1987;(26):9-24.
9.
Apuzzo ML, Yoshinaga-Itano C. Early identification of infants with significant
hearing loss and the Minnesota Child Development Inventory. Semin Hearing.
1995;16:124-37.
10. Robinshaw HM. Early intervention for hearing impairment: differences in the timing
of communicative and linguistic development. Br J Audiol. Dec 1995;29(6):315-34.
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PATIENT INFORMATION SHEET
Title: Universal Newborn Hearing Screening in a Tertiary Health Centre in North
East India
Date:
This study is being performed to find out the incidence of congenital hearing loss
amongst the North-Eastern India population delivered in a Tertiary health Care Centre.
In this study we will also try to find out the common associated factors amongst those
newborns or infants born with congenital hearing loss.
Principal Investigator:
Dr Henry Benson Nongrum
Consultant
Department of Otolaryngology and Head & Neck Surgery
Nazareth Hospital,
Shillong.
31
PATIENT INFORMATION SHEET
Title: Universal Newborn Hearing Screening in a Tertiary Health Centre in North
East India
Date:
Kane ka jingpyrshang jong ngi ka long ban wad ba katno ki don ki khyllung kiba kha lem
bad ka jingduna ha ka bor iohsngew. Ka jingwad jong ngi ka long tang ia kito ki ba kha
ha kane ka hospital, kaba long ha kliar tam napdeng ki jaka ai sumar ha ka jylla. Ka
jingpyrshang jong ngi kan long ruh ban wad ia ki daw kiba iasnoh lang lane kiba long ki
daw kaba pynlong ia I khyllung ban kha lem bad ki jingduna ha ki bor jingiohsngew
namar ka jingkthah ia ki thied ki jaw kiba iadei bad ka jingiohsngew.
Principal Investigator:
Dr Henry Benson Nongrum
Consultant
Department of Otolaryngology and Head & Neck Surgery
Nazareth Hospital,
Shillong
32
NAZARETH HOSPITAL, Shillong
Hearing Screening Consent Form
Principal Investigator; Dr Henry Benson Nongrum
Dear Parent,
It is through hearing that your child will learn to talk. Approximately 3 newborns per 1000 are born with
hearing loss. Although it is unlikely your baby will have a hearing loss, if there is one, it is important that
you know about it as soon as possible.
The first two years of your child’s life are the most important for learning speech and language. It is
important to diagnose hearing problems early because a hearing loss can prevent your baby from
learning speech and language.
Before your new baby leaves the hospital, we will do a hearing screening. The purpose of the screening
is to check your baby’s ability to hear and to help find those babies who need more hearing testing. We
are screening for a mild hearing loss or greater.
Your baby will receive one or both of the tests below.
____________________________________________________________________________________
Evoked Otoacoustic Emissions test (EOAE). This test will not hurt your baby. Most babies sleep
through the test. A soft rubber earphone is placed in your baby’s ear and makes a soft clicking sound.
Healthy ears will “echo” the click sound back to a tiny microphone that is inside the earphone. Both ears
will be tested.
____________________________________________________________________________________
____________________________________________________________________________________
Brainstem Auditory Evoked Response test (BAER). This test will not hurt your baby. Most babies
sleep through the test. Special sensors are placed on your baby’s skin. A soft rubber earphone sends a
series of quiet sounds into your sleeping baby’s ear. The sensors measure the response of your baby’s
hearing nerve. These responses are recorded and stored in a computer. Both ears will be tested.
__________________________________________________________________________________
Please ask your doctor or nurse if you have any questions about the hearing screening.
CONSENT
I authorize/request a hearing screening test for my newborn,
Date
Signature of Parent/Legal
Guardian
I DO NOT wish to have this service provided at this time. The importance of testing my newborn’s hearing
has been explained to me, and I will contact my pediatrician if I decide to have my baby’s hearing tested
at a future date. I release Nazareth hospital, physicians and staff of any liability by requesting such. I have
read and fully understand the brochure “Newborn Hearing Screening” and accept full responsibility for
choosing not to have this test performed.
Date
Signature of Parent/Legal Guardian
33
NAZARETH HOSPITAL, Shillong
Hearing Screening Consent Form
Principal Investigator; Dr Henry Benson Nongrum
Na ka bynta ki Kmie/ki kpa,
Dei lyngba ka jingtreikam ki shkor ba i khyllung in nang ia ka ktien ka thylliej. Kumba 3 na ki 1000 ki
khyllung la kha bad ka jingduna ka bor jingiohsngew. I khyllung jong phi lehse in ym don ki jingduna,
hynrei lada I don, ka long kaba kongsan eh ban tip dang kloi katba lah.
Ka snem kaba nyngkong bad kaba ar ka long kaba kongsan bha ha ka kyrta ki khyllung ba kin nang ia ka
ktien ka thylliej. Kumta ka long kaba donkam ban tip ba I khyllung I iohsngew bha ne em, namar lada ka
bor jingiohsngew ka tlot, ka lah ban khang lynti ia I khyllung ban nang kloi ia ka ktien ka thylliej.
Shuwa ba I khyllung in mih na hospital, ngin test ia ka bor jingiohsngew jong i. Ka daw ba ngin leh ia kane
ka “Screening Test” ka long ban tip ia ka jingiohsngew jong I khyllung bad ruh kino ki khyllung kiban
donkam ban test shuh shuh.
Ngin leh kawei ne ar tylli na kine ki test harum.
____________________________________________________________________________________
Evoked Otoacoustic Emissions test (EOAE). Kane ka test kan ym pynmynsaw ia i khyllung. Bun ki
khyllung kin iohthiah ha ka por ba leh ia ka test. Ngin pyndait ia ki “Earphone” ha ki shkor bad ngin ai ia ki
jingsawa (Sound) iba rit bha. Da kane ngin lah ban tip ia ka bor jingiohsngew lyngba ki jingthew ha ki kor
computer. Ngin test ia ki shkor baroh arliang.
____________________________________________________________________________________
____________________________________________________________________________________
Brainstem Auditory Evoked Response test (BAER). Kane ka test kan ym pynmynsaw ia i khyllung.
Bun ki khyllung kin iohthiah ha ka por ba leh ia ka test. Ngin pyndait ia ki “Earphone” ha ki shkor bad ngin
ai ia ki jingsawa (Sound) iba rit bha.Ngin pyndait ruh ia ki sensor ha shyllang. Da kane ngin lah ban tip ia
ka jingtreikam ki thied ki jaw ha ki shkor. Ngin thew ia kine da ki kor computer. Ngin test ia ki shkor baroh
arliang.
__________________________________________________________________________________
Phi lah ruh ban kylli bniah na ki doctor ne ki Nurse shaphang kane ka screening ia ka jingiohsngew.
CONSENT
Ngi Mynjur ban test ia ka bor jingiohsngew jong I khyllung jong ngi.
Tarik
Jingsoi da ki kmie ki kpa /
Bahaiing
Ngim mynjur ban leh ia kane ka test mynta. Ka jingdonkam ban leh ia kane ka test lah batai bniah ia ngi,
bad ngin ia kren shuwa bad ki doctor lane ki nurse lada ngi kwah ban leh ia kane ka test hadien. Ngim ym
kynnoh sniew ia ka hospital lane kiba trei ha hospital ba ki tyrwa ia ngi ban leh ia kane ka test, namar ka
jingtyrwa ka long na ka bynta ka jingbha ka lawei I khyllung hi. Ngin kitkhlieh hi ruh ia kane ka rai ka jong
ngi.
Tarik
Jingsoi da ki kmie ki kpa / Bahaiing
34