Of health sciences, karnataka, bangalore



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RAJIV GANDHI university OF HEALTH SCIENCES, KARNATAKA, BANGALORE

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION



1.

Name of the candidates and address

(in block letters)

Dr. SHARAN KUMAR DESHMUKH

DEPARTMENT OF PEDIATRICS

MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585 105




Permanent Address

Dr. SHARAN KUMAR DESHMUKH

S/O BASAWARAJ DESHMUKH

H.NO.1-1165/12(4),AIWAN-E-SHAHI

COLONY, PDA COLLEGE ROAD,

GULBARGA-585102 (KARNATAKA)

2.

Name of Institution

H.K.E. SOCIETY’S

MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585 105.

3.

Course of study and subjects

M.D.(PEDIATRICS)

4.

Date of admission to the course

30.05.2012

5.

Title of topic

RETINOPATHY OF PREMATURITY: A

CLINICAL STUDY

6.

Brief Resume of the intended work




6.1

Need for the study







Retinopathy of prematurity(ROP)is a disease related to low birth weight, prematurity, oxygen administration, and other unidentified factors.

There are several compelling reasons to have screening progamme for retinopathy of prematurity. Firstly, the premature child is not born with ROP and retinal disease is not present at birth. Each such child has a potential for normal vision, even if the retina is immature at birth. Screening aims to identify those infants who have reached or have the potential to reach threshold ROP, which if untreated may cause blindness or visual impairment. This has medicolegal implications. There are indefensible legal repercussions should an infant develop ROP and retinal detachment, but had not received eye examination. Secondly the grief and personal tragedy for the family is tremendous, besides the economic burden of such childhood blindness. Early recognition of ROP by screening provides an opportunity for effective treatment.

While the incidence of retinopathy of prematurity is on the wane in west, thanks to the improvement in neonatal care and screening. In India we are just beginning to face the storm mainly due to increased awareness. The most important determinant of any retinopathy of prematurity management program is an effective screening strategy. So retinopathy of prematurity is becoming a major cause of potentially preventable blindness among children in middle income countries that have introduced neonatal intensive care units for preterm and low birth weight babies.

The present study is first of its in North Karnataka state to avoid blimdness in premature babies born between 27-34 weeks of gestation.ROP screening helps the neonate from loosing vision permanently by repeated screening and intervention at proper intervals and finding incidence of ROP will help Government to deal with blindness arising from prematurity and exposure of neonates to oxygen.






6.2

Review of Literature



In general, prematurity, low birth weight, a complex hospital course, and prolonged supplemental oxygen are today’s established risk factors for the development of ROP1.


In 1984 the committte for the classification of retinopathy of prematurity2 presented an international classification of retinopathy of prematurity.
According to study done by cryotherapy for retinopathy of prematurity co-operative group3, it supports the efficacy of cryotherapy in reducing the unfavorable retinal outcome from threshold retinopathy of prematurity.
A study conducted by Benner et al4 suggested that both diode and argon laser indirect ophthalmoscopy appear to be equally effective in treating threshold retinopathy of prematurity. But patients with argon laser indirect ophthalmoscopy sustained burns of the tunica vasculosa lentis and anterior lens capsule.
In a study done by Gopal L et al5 a total of 50 infants of less than 2000 gm birth weight were screened for retinopathy of prematurity (ROP) by binocular indirect ophthalmoscopy. The incidence of ROP was found in 19 patients (38%). Of these, 8 patients (16 eyes) had threshold disease. Significantly, occurrence of threshold ROP was seen in both 1600 gm birth weight in one infant and in the absence of oxygen administration in 2 infants. Ten of the 16 eyes underwent therapeutic intervention while 6 eyes did not receive treatment for lack of consent from the parents. The treatment consisted of indirect laser photocoagulation (8 eyes) and transconjunctival cryopexy (2 eyes). Good regression of the disease (favourable outcome) was noted in all the treated eyes.
A study done by rohit charan et al6 showed that Babies with lower birth weights and lower gestation age at birth had a significantly higher incidence of ROP.
A study done by Donna M knight-Nanan et al7 showed that refractive error(myopia)fallowing diode laser is less as compared to cryotherapy.
A study conducted by Dr.Clare Gilbert et al8 showed that retinopathy of prematurity is becoming a major cause of potentially preventable blindness among children in middle income countries that have introduced neonatal intensive care services for preterm and low birth weight babies.

A study done by Varugese S et al9 conducted in large maternity unit with a medium size level-3 nursery describes the extent of severity of retinopathy of prematurity. Screening of 79 preterm babies showed that ophthalmic examinations should become an important part of neonatal care.

A study conducted by Parag K Shah et al10 suggested that binocular indirect ophthalmoscope is the gold standard for screening retinopathy of prematurity.


6.3

Objectives of the study
To know the incidence and outcome of RETINOPATHY OF PREMATURITY in all neonates between 28-34 weeks of gestation admitted in NICU of Basaveshwar Teaching & General Hospital and Sangameshwar Teaching Hospital attached to M.R.Medical College, Gulbarga.


7.

Materials and methods




7.1 Source of Data



All neonates born between 28-34 weeks of gestation admitted in NICU, who are under oxygen, screened for ROP







7.2 Methods of collection of data(including sampling)







  1. Place of study : Basaveshwar Teaching & General Hospital and Sangameshwar Teaching Hospital attached to M.R.Medical College, Gulbarga




  1. Duration of study : December 2012 to May 2014

Sample size : 100



Inclusion Criteria

  1. All neonates born between 28-34 weeks of gestation admitted in NICU, who are under oxygen, screened for ROP

  2. Both sexes.

Exclusion Criteria

  1. Neonates >35 weeks of gestation.






7.3 Does the study require any investigations or interventions to be conducted on Patients or other humans or animals? If so please describe briefly.




Yes

Genarally investigations are not necessary and are required only in the following instances.



  1. Anemia (Hb%)

  2. Septicemia (Total leucocyte count, differential leucocyte count, toxic granules, band count, CRP, blood culture, cerebro spinal fluid examination.)

  3. Hyperbilirubinemia (Vandenberg test- Direct, indirect)

  4. Intraventricular haemorrhage. ( C.T scan)

  5. PDA/other malformations. (Echocardiography)





7.4 Has ethical clearance been obtained from institution in case of 7.3?





Yes, ethical clearance has been taken from “ethical clearance committee” of the

institution.






8. References





  1. Stephen J. Ryan. Retina. Fourth edition, volume 2, section 5, chapter 80, page 1464.

  2. The Committee for the Classification of Retinopathy of Prematurity. An International Classification of Retinopathy of Prematurity. Arch Ophthalmol 1984;102:1130-1134.

  3. Cryotherapy for Retinopathy of Prematurity Co-operative Group: Multicentre trial of cryo therapy for retinopathy of prematurity. Preliminary results. Arch Ophthalmol 1988;106:471-479.

  4. BENNER, JEFFREY D, MORSE, LAWRENCE S, HAY, ANDY, LANDERS, MAURICE B. A Comparison of Argon and Diode Photocoagulation Combined With Supplemental Oxygen for the Treatment of Retinopathy of Prematurity. Retina 1993;13(3):222-229.

  5. Gopal L, Sharma T, Ramachandran S, Shanmugasundaram R, Asha V. Retinopathy of prematurity: A study. Indian J Ophthalmol 1995;43:59-61.

  6. Charan R, Dogra MR, Gupta A, Narang A. The incidence of retinopathy of prematurity in a neonatal care unit. Indian J Ophthalmol 1995;43:123-6

  7. Donna M Knight-Nanan, Michael O'Keefe. Refractive outcome in eyes with retinopathy of prematurity treated with cryotherapy or diode laser: 3 year follow up. British journal of Ophthalmology 1996;80:998-1001.

  8. Dr Clare Gilbert MD, Jugnoo Rahi FRCOphth, Michael Eckstein FRCOphth, Jane O'Sullivan FRCOphth, Allen Foster FRCOphth. Retinopathy of prematurity in middle-income countries. The Lancet, 5 July 1997; Volume 350, Issue 9070, Pages 12 – 14.

  9. Varughese S, Jain S, Gupta N, Singh S, Tyagi V, Puliyel JM. Magnitude of the problem of retinopathy of prematurity. Experience in a large maternity unit with a medium size level-3 nursery. Indian J Ophthalmol 2001;49:187-8.

  10. Shah PK, Narendran V, Saravanan VR, Raghuram A, Chattopadhyay A, Kashyap M. Screening for retinsopathy of prematurity-a comparison between binocular

indirect ophthalmoscopy and RetCam 120. Indian J Ophthalmol 2006;54:35-8.




9.


Signature of Candidates





10.

Remarks of Guide


With the advent of large number of level II and level III NICU coming up and resultant survival of premature baby and in whom we see lot of ROP. So to know the incidence and also get treated for the same this study is helpful.

11.




Name and designation of the

(In block letters)









11.1

Guide


Dr. SHARANAGOUDA PATIL

M.D

associate PROFESSOR,

DEPARTMENT OF PEDIATRICS,

MAHADEVAPPA RAMPURE Medical COLLEGe, GULBARGA-585105



11.2

Signature







11.3

Co-guide







11.4

Signature







11.5

Head of the Department


Dr.SHRIKANT S.W.

PROFESSOR & HEAD

DEPARTMENT OF PEDIATRICS

MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA






11.6


Signature





12

12.1

Remarks of the chairman and principal








12.2



Signature






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