RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES BANGALORE

ANNEXURE II

THESIS SYNOPSIS

1. Name of candidate and Address Dr. Manjunatha Prasad

Post Graduate in

Department of ENT

A.J. Institute Medical Science

Mangalore

2. Name of the Institution A.J. Institute Medical Science

Mangalore

3. Course of Study and Subject MS in ENT

4. Date of Admission June 2009

5. Title of Topic Neonatal Screening for hearing loss

using DPOAE and Comparison it with

Conventional Clinical Methods – A

Pilot Study

6. Brief Resume of the intended Work

6.1 Need For the Study Hearing loss in children constitutes a considerable

handicap because it is invisible disability &

compromises optimal development & personnel

achievement of a child. Congenital Sensorineural

hearing impairment has been estimated 1.2 – 5.7 /

thousand live birth (1- 5) .

The Prevalence of hearing loss in infant is more than

twice that of other Screened new born disorders like

hypothyroidism and phenyl ketonuria (6) . In addition 50

per. of children with moderate to propound congenital

hearing loss exhibit no risk factor for hearing loss (6-

10). Early detection followed by appropriate treatment

provided the best choice maximizing the critical period

of hearing to avail of resources to improve hearing and

oral communication skills. On the other hand late

deduction and treatment leaves the childe with poor

speech development and school achievement

6.2. Review of literature A study was done at Christian Medical College Vellore

from 2005 t0 July 2005 – 500 new burns were included

using the machine SMART –DPOAE. It included both

normal and high risk neonates. In this study neonates

under went for screening negative respond response was

6.4 per. on repeat testing of 32 (6.4 per) neonates with

a DPOAE, 8(25 per) continues to have a negative

response. Further testing with a ABR with 40 dB

threshold level -3 showed no response but with 70 dB

threshold level they all passed. This study states

prevalence of mild to moderately sever sensorineural

hearing loss is 0.6 per (11)

A study done at university of Ferrara Italy using both

DPOAE and TEOAE a group of 250 neonates were

screened with the DPOAE response for a worked by on

a symmetrical 75 65 dB SPC Protocol, with a frequency

ratio of 1.22. 5 frequency pretested 1.5 2.0 3.0 4.0 and

5.0 KHZ (12)

A study done at university of Michigan health system to

compare effectiveness and utility of DAPAE and ABR

testing as screening methodologies suitable for

universal application at large birthing hospital. 569

neonates without risk indicators for hearing loss

underwent DPOAE and ABR Screening before hospital

discharge at birth. All the ears passed ABR Screening.

DPOAE results for categories on the basis of no of

frequency at which emission pass obtained as well as

presents verses absence of replicated response at which

each test frequency passed and refer rates varied widely

on the basis of whether the present of DPOAE response

at 2000HZ or replications for required. With the most

stringent criteria, only 64.44 % of ears passed, where as

with the least stringent criteria 88.94% passed. Giving

that 100% ears passed according to the gold Std of the

ABR Screening these results indicates false positive

rates ranging from 11% to 35 % by DPOAE Screening

this discrepancy in pass and refer rates when various

criteria are applied indicates the need for the

standardization and further comparison of appropriate

pass criteria for new born hearing screening program.

(13) .

At Christ church Women’s Hospital New Zealand 12

months study in which 435 babies were screened for

hearing loss using DPOAE the machine GSI-70 which

provides either a pass or refer results at 2000, 4000 and

6000 Hz. Only NICU admitted neonates are screened.

In total 435 babies under went universal neonates

hearing screening of those 389 (89.4%) passed the

screening on the 1st test the 46 babies that required 2nd

Screening 19 babies failed the 2nd screening and were

referred for diagnostic ABR, the 19 babies (4.37%) who

did not pass the retest were referred to the diagnostic

ABR at Christ church Hospital timed to 1 month past

their due date. The diagnostic area conformed that 2

babies a moderate to sever bilateral sensory neural

hearing loss importantly, one of the babies had no risk

factor for deafness while the other had hearing last loss

part of a congenital syndrome (14)

6.3 Objective of the

study

This study is directed to words early identification of

deafness in neonates using DPOAE with the

OTOREAD Screener (machine) .

This study compares DPOAE with other conventional

clinical methods which are there for hearing screening.

7 Material and Methods

7.1 Source of Data Neonates born at AJ institute of Medical Science and

occupying the bed for 5 days

Inclusion Criteria

1. neonates born in AJ institute of Medical Science

occupying bed for 5 days between January 2010 to

December 2010.

2. Study includes both normal and high risk neonates

Exclusion Criteria

Neonates suffering from other critical illnesses they

excluded from hearing evolution until they stable

7.2 Method of

Collection of data and

sample

Data Collection

Detailed ANC history will be taken about eruptive

fever, consanguinity, family history of deafness,

ototoxicdrug intake, radiation exposure, malnutrition,

prematurity, eclampsia, birth asphyxia, prolonged,

labour, low birth Weight,

Detailed examination of neonates including ENT

examination will be done.

Using the instrument OTOREAD DPOAE is recorded in

noise free room next to the maternal word in natural

sleep, no sedation is given.

First recording of DPOAE is done with in 48 hour of

birth, If the result is PASS hearing is normal (PHASE

1)

If the result is REFER DPOAE will be repeated next

day (PHASE 2), If the result is pass hearing is normal. If

the result is refer DPOAE repeated before discharge

(PHASE 3). At the time result is pass hearing is normal,

if the result is refer neonates will go to next PHASE – 4.

In PHASE 4 at the age of 1½ Month when child come

for immunization DPOAE will be repeated, if the result

is pass hearing is normal if the result is refer neonates is

advise for ABR (PHASE-5). ABR is pass hearing is

normal if ABR is fail neonates deaf advice intervention.

For the high risk neonates even if DPOAE is pass at

birth they will be advice to under go complete audio

logical evaluation at 12 month of age (15).

In all the phases whether the neonates respond for loud

sounds will be tested (Clap), whether neonates pause

sucking bell is present (16).

PROTOCOL – FLOW CHART

Neonates (Normal + High Risk)

DPOAE Between 24-48 hr of birth PHASE - 1

Pass Refer

Hearing Normal

DPOAE Next Day PHASE – 2 Pass Normal Hearing Refer

DPOAE before Discharge PHASE – 3 Pass Normal Hearing

Refer

DPOAE at 6 Week PHASE – 4 Pass Normal Hearing

Refer

ABR before 2 month of age PHASE – 5 Pass Normal Hearing

Fail

Intervention Advised

7.3 Dose the study requires Yes, detail given in 7.2

any investigations or

interventions to be

conducted on patient or other

human or animals? If so,

please describe briefly.

7.4 has the ethical clearance

obtained four your

investigation

Clearance obtained

8. List of References 1. Watkins P, Baldwin M, Mc Enery G (1991)

neonatal at risk screening and the

investigation

of deafness. Arch Dis Child 66:1130-1135

2. Parving A (1993) Congenital hearing

disability :

epidemiology and identification : a

comparison

between two health authority districts. Int J

Pediatr Otorhimolaryngo 27:29-46

3. auk GW, Behrens TR (1993) Historical,

Political

a technological context associated with early

identification hearing loss. Seminars in

Hearing

14:1:17

4. Northerm JL> Hayes DH (1994) Universal

screening for infant hearing impairment

Necessary, beneficial and justifiable.

Audilogy

Today 6:10-13

5. Kim SY, Bothwell NE, Backousn DD (2002)

The

expanding role of the otolaryngologist in

managing infants and children with hearng

loss.

Otolaryngol clin N Am 35:699

6. Michele AM De (2004) Newborn hearing

screening. eMedicine 1-14

7. White KR, Vohr Br, Behrens TR (1993)

Universal

newborn hearing screening using transient

evoked otoacoustic emissions: Results of the

Rhode Island hearing assessments project.

Seminars in Hearing 14:18-29

8. White K Maxon A (1995) universal

screening for

the hearing impairment : simple, beneficial

and

Presently justified. INT J Pediatr

Otorhinolaryngol

32(3):201-211

9. Mehl A, Thompson V (1998) newborn

hearing

Screening: The Great omission. Pediatrics

101:1

10. Isaacson G (2001) Universal Newborn

Hearing

Screening and Intervention. Advances in

Otolaryngology-Head and Neck Surgery

15:1-19

11. M. Jhon . A. Balaji, M. Kurien. Neonatal

Screening for hearing loss: pilot Study from

Tertiary care center. Indian J

Otolaryngology –

Head neck surgery (Jan. – March - 2009)

61:23-26

12. Hatzopoulos. S, PELOSI G,

OETRUCCESSI J.

ROSSI M., VIGI V, CHIERICI R,

MARTINI A.

efficient Otoacoustic emission protocols

employed in hospital based Neonatal

Screening program. ACTA

otolaryngologica

ISSN 0001-6489 CODEN

AOLAAJ:2001:VOL:

121:N2(204)(23Ref),PP.269-273.

13. Susan E: Barker, Marci M. Lesperance and

Paul

R. Kileny. Out come of new born hearing

screening by ABR compared with four

deferent

DPOAE pass Criteria. American Journal of

Audilogy : VOL 8; December 2000; 142 to

149

14. Mark Flynn, Nicola Austin, Traci

Schmidtke

Flynn, Rodney Ford, Liz Buckland.

Universal

newborn hearing screening introduced to

NICU

infants’ in CANTER BURY PROVINCE,

New Zealand. The new Zealand Medical

Jurnal :

VOL:117 No 1206 ISSN 8716 : page No :

1 to 9 :

November 2004

15. Mohd . Shamim Ansari , Anirban Biswas.

Implementation of nation wide newborn

hearing screening program in India.:

Necessity

Significance, justification and suggested

Protocol. Journal of Indian society of

otology ;

June 2003 ; VOL.2 No. 142; Page No,. 127

16. Nelson text box of Pediatric : 18th edition :

VOL

2; Page No. ; 2436

9. Signature of Candidate:

10 Remarks of the Guide This is an excellent work which will have

profound impact on early detection of hearing

loss in new born children.

11. 11.1 Name and designation

of Guide

Dr. Devan P. P.

Professor & HOD of ENT

A.J. Institute of Medical Science Mangalore.

11.2 Signature

11.3 Go –Guide (if any) No

11.4 Signature No

11.5 head of the department

:

Dr. Devan P. P.

Professor & HOD of ENT

A.J. Institute of Medical Science Mangalore

11.6 Signature

12 12.1 Remarks of the

Chairman and Principal

12.2 Signature

BUDGET ANALYSIS

TITLE: - Neonatal Screening for hearing loss using DPOAE and Comparison it

with

Conventional Clinical Methods – A Pilot Study

PRINCIPAL INVESTIGATOR: - Dr. Manjunatha Prasad Post Graduate

ENT A.J. Institute of Medical Science, Mangalore

DETAILED BUDGET FOR THE WHOLE PROJECT:-

SL

NO.

PARTICULAR TOTAL COST Rs.

1. Personal 1000.00

2. Investigation 2000.00

3. Printing & Copying supplies 5000.00

4. Miscellaneous 1000.00

Total 9000.00

TIMELINE

TITLE : - Neonatal Screening for hearing loss using DPOAE and Comparison

it with

Conventional Clinical Methods – A Pilot Study

Phase Time Period Activity

1. June - 2009 to

December – 2009

1. Identification of the Problem

2. Review of literature

3. Preparing of Proforma

4. Pilot Study

5. Preparation and submission of synopsis

2. January 2010

To

December 2010

Collection of Data

3. January 2011

To

November 2011

Analysis and Discussion of collected data

Publication

From,Dr. Manjunatha Prasad,Post Graduate in Department of ENTA.J. Institute of Medical Science Mangalore

To,The Registrar (Evaluation)Rajiv Gandhi University of Health SciencesBangalore, Karnataka

(Through Proper Channel)

Sub:- Submission of Synopsis of Dissertation

Respected Sir,

Herewith, I am submitting synopsis of my dissertation work “Neonatal Screening for hearing loss using DPOAE and Comparison it with Conventional Clinical Methods – A Pilot Study” for registration in M.S. (ENT) of A.J. Institute of Medical Science Mangalore.

Kindly accept the same and oblige.

Thanking you. Yours faithfully,

Place : Mangalore Date : 17.11.2009 (Dr. Manjunatha Prasad)

Head of the Department DEAN

A. J. Institute of Medical Science MangaloreDr. Devan P.P.

Prof. and Head, Department of ENT A.J. Institute of Medial Science

Appendix B. SAMPLE CONSENT FORM

TITLE OF RESEARCH Neonatal screening for hearing loss using DPOAE and Comparison it with

Conventional Clinical Methods – A Pilot Study

INVESTIGATORS: DR. DEVAN P.P., DR. MANJUNATH PRASAD

INTRODUCTION:-

You are being invited to participate in research project design to

early identification of hearing loss in newborn using DPOAE and comparing

with it other conventional clinical methods. This study directed towards early

identification of deafness in neonates using Oto read Instrument this has been

used in many countries for early identification and so that early intervention

can be possible, early intervention will leads to improve hearing and oral

communication skills. In this project you have been selected because you baby

was born in A.J. Institute of Medical Science.

EXPLANATION OF PROCEDURES:-

In this project if you are selected DPOAE us recorded in both the ears

using Oto read instrument, Mother will be asked about high risk related

questions. Neonates examined for hearing making loud noise.

POSSIBLE BENEFITS:

The investigator do not promise are guarantee that you are baby will

received direct benefit being in the study. Information gained from the study

main benefit at other risk babies in the future. There also may be benefits

involved that are not known to the researches at this time.

POSSIBLE RISKS:-

There are no known physical risks for the child are person associate with

these methods.

ALTERNATIVE PROCEDURES:-

If you don’t want your baby to participate in the study He /She will

received the usual care given in the hospital.

CONFIDENTIALITY:-

The result of the study may be published for scientific purpose, however

your identification will not be revealed. All the information colleted will be

collected and coated so that no one will known your identity.

WITHDRAWAL:-

Participation in the study Is voluntary, if you do not wish to participate in

the study your baby will not loose benefits to which He/She entitled. You are

free to withdraw your consent and discontinued your babies’ participation in

this project at any time.

SIGNIFICANT NEW FINDINGS

Any significant new findings discovered during the course of the study,

which may influence your decisions to allow your baby to continue

participations, will be made known to you.

COSTS OF PARTICIPATIONS

The cost of the study will be covered by a research grant, there will be no

additional cost to you for participating in this study.

PAYMENT OF PARTICIPATION.

There will be no payment to you or your baby for participating in this

study

Payment of Research Related Injuries.

If, as a result of your baby’s participation, He/She experiences injuries

from known or unknown risk of the research procedures as described,

immediate care and treatment, including Hospitalization in necessary, will be

available. Neither UAB, A.J. Institute of Medical Science as made provision for

monetary composition in the event of injury resulting from the research and in

the event of such injury, treatment is provided, at free of charges.

QUESTIONS:

If you have any questions about this study, questions about a research

related injury or experience any problems during the study, you should contact

Dr. Manjunatha Prasad at 9448628475 and Dr. Devan P.P. at 9243301213. if

you have questions about your rights as a research participant, you may contact

Research Ethics Committee AJIMS Mangalore.

LEGAL RIGHTS

By signing this consent form, you are not waiving any of your or your

child’s legal rights.

CONSENT STATEMENT

My signature below indicates that I have decided to let my baby

participate, that I have read (or been read) the information provided above, that

I was given the opportunity to ask questions and that they have answered to my

satisfaction, and that I have received a copy of this signed consent form.

__________________________________

_____________________________

Signature or Thumbprint of parent or Date

Legally Authorized Representative

__________________________________

_____________________________

Signature of Person Obtaining consent Date

If other than the Principal Investigator

__________________________________

_____________________________

Signature of Principal Investigator Date

__________________________________

_____________________________

Signature of Witness Date

A. J. INSTITUTE OF MEDICAL SCIENCE MANGALORE

Title:-

“Neonatal screening for hearing loss using DPOAE and Comparison

it with Conventional Clinical Methods – A Pilot Study”

PROFORMA FOR DATA COLLECTION

A. Personal Details

1. Name :

2. Age :

3. Sex :

4. Weight :

5. I.P. No. :

6. DOD :

7. DOA :

8. DOB :

9. Date of collection of Data :

10. Address :

11. Mother Name & Occupations :

13. Father Name & Occupations :

14. Family Income :

15. Has mother attended ANC Clinic regularly (Y/N):

B. Questionnaire for high risk factor:

1. Consanguinity (Y/N) :

2. Family history of neonatal deafness (Y/N) :

3. Toxic drug intake (Y/N) :

4. Eruptive fever (Y/N) :

5. Pre-ecclampsic toxemia (Y/N) :

6. Malnutrition (Y/N):

7, History of repeated abortion (Y/N) :

8. Radiation exposer (Y/N) :

9. Parity (Y/N) :

10. Pre – Maturity (Y/N) :

11. Prolonged labour (Y/N) :

12. low birth weight (Y/N) :

13. Birth asphyxia (Y/N) :

14. Syndrome Associated with hearing loss (Y/N) :

15. Craniofacial Anomaly (Y/N) :

16. Apgar score 0 - 4 at 1 minute and 2-6 at five minute after birth (Y/N) :

17. Skin tag preauricular (Y/N) :

18. NICU Admission more then 3 days (Y/N) :

C. EXAMINATION OF NEONATE:

General Physical Examination: weight (more them 1500) Y/N

Icturus Y/N, Consanguinity (Y/N), Dwarfism (Y/N), Micro cephalic

(Y/N),Down syndrome(Y/N), Goiter (Y/N), Polydactyl (Y/N), High Arched

Palate (Y/N), Kyphosis (Y/N), Mandibular Hypoplasia (Y/N), Congenital

bell’s Palsy (Y/N),

D. ENT Examinations:-

Ear

Skin Tag a preauricular region

Steno sis external canal

Muconium in here canal / wax Other findings

Nose

Throat

E. Systemic Examinations: - CVS

RS

PA

F. Weather neonate respond for loud sound (Clap) (Y/N).

Weather newborn pause sucking when bell is present (Y/N)G. RECORDING OF RESULTS

PHASE Date DPOAE Result Passed in conventional

Screening Method

I PASS / REFER Y/ N

II PASS / REFER Y/ N

III PASS / REFER Y/ N

IV PASS / REFER Y/ N

V PASS / FAIL Y/ N

H. Advice to Parents

PHASE Date Advise

PHASE 1 Hearing Normal / DPOAE will be repeated

next day

PHASE 2 Hearing Normal / DPOAE repeated before

discharge

PHASE 3 Hearing Normal / DPOAE will be repeated

when the child come for immunization at 6

week of age.

PHASE 4 Hearing Normal /ABR to be done before 2

Month of age.

PHASE 5 Hearing Normal / Intervention