RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BANGALORE

KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1.

Name of the Candidate and Address

DR. ARJUN.S.K

( In Block Letters )

S/O KAMARAJA GUPTA .S.T

GUPTA CHIT FUNDS,
R.T.STREET
SIRA 572137 (TUMKUR DIST.)
KARNATAKA.

Name of the Institution

J.J. M. MEDICAL COLLEGE,

DAVANGERE 577 004
KARNATAKA.

3.

Course of the study and Subject

POST GRADUATE
M.D. IN PEDIATRICS

4.

Date of Admission to the Course

09/05/2011

5.

Title of the Topic

STUDY

OF

BRAINSTEM

EVOKED

RESPONSE AUDIOMETRY IN HIGH

RISK

NICU

GRADUATES

IN

TERTIARY CARE CENTER

6.

Brief Resume of the Intended Work

6.1 Need for the Study
Severe pre-lingual hearing impairment has important consequences
for language acquisition , communication , and cognitive, social ,and emotional
development . Indeed evidence is increasing that even moderate hearing loss in very
young children can be detrimental.1
Hearing loss presents high incidence, affecting around 3 out of every 1000
live births, and 2 to 4 out of every 100 newborns leaving the neonatal intensive care
unit(NICU). The initial signs of hearing loss are very subtle and systematic neonatal
hearing screening is the most effective means of early detection. Early diagnosis and
immediate intervention are decisive factors in the development and prognosis of these
children.2
During the past 30 years, infant hearing screening have been attempted with a
number of different methods using behavioral and physiological measures. Brainsten

evoked response audiometry is one of the objective methods of hearing screening.

Brainstem evoked response audiometry, when used and interpreted properly, provide a
powerful method of obtaining reliable estimates of auditory sensitivity in infants , young
children, and other individuals who cannot or will not provide reliable results on
behavioral hearing tests.3
Hence I intend to undertake a study on Brainstem evoked response
Audiometry (BERA) in all high-risk NICU graduates :in 3 hospitals attached to JJM
Medical college, Davanagere.
6.2 Review of Literature
Meyer C, Witte J, Hildmann A, Hennecke KH, Schunck KU, Maul K et al
studied Seven hundred seventy recordings from 777 infants enrolled consecutively
constitute the basis of this analysis. Mean gestational age was 33.8+/-4.3 weeks, birth
weight 2141+/-968g; 431 infants being male and 339 female; 41(5.3%) infants exhibited
pathologic A-ABR results(16 bilateral and 25 unilateral). Follow-up examinations in 31
infants revealed persistent hearing loss in 18 infants (13 infants sensorineural, 5 from
mixed disorders), 7 requiring amplification.4
Zamani A, Daneshjou K, Ameni A, Takand J performed a cross-sectional
study on 230 neonates who were at risk of hearing loss in

Tehran University of

medical sciences hospitals between September 2000 and February 2002. Hearing was
examined before 3rd month by auditory brainstem responses (ABR) . Eighteen
neonates (8%) had sensorineural hearing loss . They found significant statistical
relationships between hearing loss and craniofacial anomalies(P value<0.000001), the
neonates

age

during

hospitalization (P value <0.0005),

hyperbilirubinemia (P

value<0.001), using artificial ventilation (P value<0.05) and use of ototoxic drugs(P

value<0.05).5
Taghdiri M M , Eghbalian F , Emami F , Abbasi B et al studied that out of
834 neonates , 34(4.07%) had sensory-neural hearing loss. The most common risk factors
of hearing loss included hyperbilirubinemia(11%), asphyxia(8%), birth weight less than
1500g(6%), septicemia(6%),

convulsion(2%) and meningitis(1%).There

was a

statistically significant association between hyperbilrubinemia(P=0.001), weight less

than 1500g(P=0.002), cesarian section(P=0.005) and impaired ABR results. There was
no relation between family history of congenital hearing loss and craniofacial
malformation as risk factors for hearing loss.2
Aiyer R G, Parikh B recorded Auditory brainstem responses (ABR) in 30
normal and 60 high risk neonates with a gestational age between 30 and 45 weeks .
The normative data of normal group

as regard to age , sex , and various

parameters of ABR were compared with high-risk group. 12 of the high-risk neonates
showed mild to moderate hearing impairment and 2 of them showed severe to
profound hearing impairment. 9 of the failed group were reevaluated within 3 months
and several times thereafter

if

the abnormal

infants showed persistent hearing

responses persisted. 2 ( 3.3% )

loss , which was confirmed by behavioral

audiometry.3
6.3

Objectives of the study

To know the hearing impairment by Brainstem evoked response audiometry
(BERA) in high risk NICU graduates and

to analyse the associated risk

factors.
7

Materials and Methods

7.1 Source of Data
In this study High-risk infants having one or more risk factors, according to the
criteria stated by American Academy of Pediatrics, Joint committee on Infant Hearing
are selected from 3 hospitals attached to J.J.M. Medical College, Davanagere namely,
Bapuji child health institute and research centre, Davangere.
Chigateri general hospital, Davangere.
Women and children hospital, Davangere.
7.2 Method of Collection of Data (Including Sampling Procedures if any)
The study performed to evaluate all neonates who were hospitalized or referred
to the hospitals attached to J.J.M. Medical College from November 2011 to November
2013 .All patients were followed up and High-risk patients were referred for Brainstem
evoked response audiometry (BERA) at 3 months to 6 months of their corrected age.7

Inclusion Criteria
Family history of permanent childhood hearing loss.
In utero infections (toxoplasmosis, rubella, cytomegalovirus, herpes simplex
virus infections, and syphilis )

 Craniofacial anomalies
Birth weight >1500gms
Hyperbilirubinemia at serum levels requiring phototheraphy and or exchange
transfusion
Ototoxic medications (eg; aminoglycosides alone or in combination with loop
diuretics )
Bacterial meningitis
Birth asphyxia ( Apgar <5 at 1 minute or <6 at 5 minutes )
Mechanical ventilation lasting 3 days or longer
Gestational age <37 weeks.
Exclusion Criteria
Babies more than one year of life
Severe multiple anomalies incompatible with life
Untreated otitis externa
Atresia or stenosis of external ear canals of both ears.
Sample Size and Design
Initially a minimum of fifty cases are intended to be taken up. However the
scope of increasing the number of cases also exists depending upon the study pattern.
Method of Examination
Purpose of the study will be explained to the parents and a pre structured proforma
will be used to record the relevant information from individual case selected for the
study. The necessary clinical examination will be conducted in the Department of
Pediatrics, all 3 hospitals attached to JJM Medical College, Davangere.
Duration of study : 2 Years
Statistical Analysis :
Proportion (%) of hearing loss will be estimated with 95% confidence interval.

7.3.

Does the study require any investigation, or intervention to be conducted on

patients or other humans or animals? If so describe briefly.
Yes
Non invasive investigations like thorough ENT examination.
All necessary relavant investigations with prior consent of parents.

7.4. Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8.

List of References
1. McClelland R J, Watson D R, Lawless V, Houston H G, Adams D. Reliability and
effectiveness of screening for hearing loss in high risk neonates.BMJ 1992;304:806-9.
2. Taghdiri M M , Eghbalian F , Emami F , Abbasi B et al. Auditory Evaluation of High
Risk Newborns by Automated Auditory Brainstem Response. Iran J Pediatr Dec 2008;
Vol 18 (No 4): 330-334.
3. Aiyer R G, Parikh B. Evaluation of auditory responses for hearing screening of highrisk infants. Indian J Otolaryngol Head Neck Surg 2009; 61:47-53.
4. Meyer C, Witte J, Hildmann A, Hennecke KH, Schunck KU, Maul K et al. Neonatal
Screening for Hearing Disorders in Infants at Risk: Incidence, Risk Factors, and Followup. Pediatrics 1999; 104:900.
5. Zamani A, Daneshjou K, Ameni A, Takand J. Estimating The Incidence Of Neonatal
Hearing Loss In High Risk Neonates. Acta Medica Iranica 2004; 42(3):176-180.
6. Kramer S J, Vertes D R, Condon M. Auditory brainstem Responses and Clinical
Follow-up of High-Risk Infants. Pediatrics 198;83:385.
7. Mishra U K, Kalita J. Clinical Neurophysiology. Elsevier 2004.

Signature of Candidate
(Dr Arjun .S. K)

10. Remarks of Guide

Hearing loss is a common problem in high risk

neonates admitted to NICU, (2-4/100 neonates).
Signs of hearing loss are subtle. BERA is the
most effective & objective method of screening
for hearing loss in young infants. Early
diagnosis and intervention help them to attain
near normal development.

11. Name and Designation (In block

letters)
11.1. Guide

Dr.SIDDANAGOUDA . S .MAJIGOUDAR
PROFESSOR,

M.D

DEPARTMENT OF PEDIATRICS,
J.J. M. MEDICAL COLLEGE,
DAVANGERE-577004.
11.2 Signature

11.3 Co-Guide (If any)

11.4 Signature

11.5 Head of Department

Dr. M.L. KULKARNI .

M.D., F.I.A.P., F.A.M.S.

F.R.C.P.H. (U.K.), F.C.P. C.C. (Lon)

PROFESSOR AND HEAD,

DEPARTMENT OF PEDIATRICS,
J.J.M. MEDICAL COLLEGE,
DAVANGERE 577 004.
11.6 Signature

12. Remarks of the

12.1 Chairman and Principal
12.2 Signature