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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
Recommended