BANGALORE.
ANNEXURE- II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE & ADDRESS / Dr.CHAYA K A POST GRADUATE IN PAEDIATRICS KIMS, HUBLI-22
2. / NAME OF THE INSTITUTION / KARNATAKA INSTITUTE OF MEDICAL SCIENCES(KIMS), HUBLI-580022
3. / COURSE OF STUDY AND SUBJECT / MD IN PEDIATRICS
4. / DATE OF ADMISSION TO THE COURSE / 31ST MAY 2012
5. / TITLE OF TOPIC / A STUDY ON INCIDENCE,RISK FACTORS AND CLINICAL PROFILE ON RETINOPATHY OF PREMATURITY IN PRETERM BABIES.
BRIEF RESUME OF THE INTENDED WORK:
6.1 Need for the study:
Retinopathy ofprematurity (ROP) is a multi-factorial vasoproliferative retinaldisorder. Prematurity being theimportantconsistentrisk factorforthe development of ROP, along with other risk factors like– low birth weight (LBW), very low birth weight (VLBW),extremely low birth weight(ELBW), unmonitored oxygen therapy, sepsis, apnea,blood transfusion, babies on mechanical ventilation for longer duration.1
Infants with birth weight <1,250 grams (g) have 65% risk of developing ROP and 80% of those with birth weight <1,000g.Indian studies reveal incidence of ROP in LBW as 38% to 51.9%.2 Worldwide around 50,000 children are blind due to ROP and majority of them belong to India and Latin America.3Initial incidence of ROP was low due to lack of adequate facilities leading to extreme mortality in VLBW and lack of awareness of screening and monitoring of ROP. However due to improving outcome of “at-risk” preterm infants, the incidence is becoming high.1
There are 1.4 million blind children,of which around 25% of blindness is due to retinal disease. In industrialized countries 15% of blindness in children is due to ROP.4 Since ROP is essentially asymptomatic in early stages without clinical signs or symptoms, present recommendation is to screen and conduct regular examination of retinal changes of ROP in “at risk” infantsto minimizerisk of visual loss.1
Blindness due to ROPhas inherent economic burden on any country’s GDP, the cost of screening and managing is much lower than the cost of productivity loss on the state exchequer.5Considering the high incidence of ROP as reported in few of the studies done in Karnataka,we are under takingthis study to look in to the incidence, risk factors, and staging of ROP in preterm babies admitted to NICU,KIMS,Hubli. This will also create an awareness of ROP screening amongst neonatologist, ophthalmologist in this part of Karnataka.
6.2 Review of the literature:
- A prospective study conducted in St.John’smedical college, Bangalore by SwarnaRekha et al on 100 babies who were below 1500 g or whose gestational age (GA) was < 34 wks(weeks)were screened for 4 year period,showed the incidence of ROP to be 46%. Stage I changes were seen in 21 babies, 14 had stage II, 8 had stage III and 3 had stages IVand V. The incidence of ROP was 73.3% among babies1000 g and 47.3% among babies < 1500 g. The incidence of ROP among 28-29 weeks, 30-31 weeks and 32-33 weeks babies were83%, 60% and 50%, respectively. The maximum stage of ROP developed between 37-42 weeks post conceptional age in 69% subjects. GA < 32 wks, anemia, blood transfusions, apnea and exposure to oxygen significantly increased the risk of developing ROP. Anemia and duration of oxygen therapy were the significant independent predictors of development of ROP.6
- A retrospective study in AIIMS,New Delhiby Pradeep kumar et al, on risk factors for severe retinopathy of prematurity in preterm LBW babies, found that among 704 neonates screened, 84(11.9%) developed any ROP and 33 (4.7%) infants had severe ROP. The mean birth weight was 1113g and GAwas 29wks. Significant risk factors were gestation ≤30 wks, birth weight <1000 g, respiratory distress syndrome(RDS), use of surfactant, apnoea, hypotension, patent ductusarteriosus(PDA), sepsis, necrotizing enterocolitis, pneumonia, meningitis, intraventricularhaemorrhage, packed cell transfusion, use of oxygen, continuous positive airway pressure and positive pressure ventilation.RDS, PDA requiring medical or surgical management and meningitis were found to be independently associated with severe ROP. All infants with severe ROP had regression of the disease after laser therapy.7
- A prospective study in Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Coimbatore,Tamil Nadu, conducted by Parag K. Shah et al on severe ROP over a period of 3 years had 114 babies who were divided into two groups. Group 1 had high risk prethreshold or threshold ROP while group 2 had stages 4 or 5 ROP. The overall mean GA was 30.7 wks (range 25–35 wks) and the mean birth weight was 1410 g (range 650–
2310 g). A statistical significant correlation was found between supplemental oxygen and severe ROP (p < 0.05) in both the groups.8
- In a study conducted in Aga Khan University, Karachi, Pakistan, by Ather M T et al, the frequency of ROP in the premature infants with birth weight <1500g or GA32 wks were analyzed. Out of 68 infants, 22(32.4%) developed ROP (inclusive of all stages) and 14 (20.6%) developed threshold disease. Low gestational age, sepsis and RDS were found to be independentpredictors of ROP development. ROP is an important emerging cause of preventable childhood blindness in urban areas.9
- In study conducted in Tata Motors Hospital and Vishnu Netralaya Hospital, Jamshedpur,Jharkhand, by Rajiv Sharan et al, evaluated the incidence and risk factor of ROP in a secondary care setting in newborns <37 wks of GA and or birthweight < 2000gas per the guidelines of International Classification of Retinopathy (ICROP). Out of 84 infants studied, 3 were excluded (died). ROP was present in 16/81 (19.7%), of whom 4 infants had stage 3 ROP or greater. The incidence of ROP requiring surgery was 4 (4.9%). Incidence of ROP in survivors <28 weeks was 67%. Threshold ROP requiring surgery in infants <28 wks gestation at birth was 75%. There was one stage 3 ROP in an infant >32 wks gestation. For infants <1000 g, the incidence of ROP of any degree was 50% (3/6), of whom 33% had threshold ROP. The birthweight and GA were significant risk factors for ROP. Their study emphasized the need to screen preterm babies >32 wk and >1500 g also.10
- In a prospective cohort study conducted by J.B.Fortes et al,they analyzed the incidence and risk factors for ROP and survival rates among ELBW and VLBW preterm infants. Of the 352 neonates screened, 88 were ELBW babies. Survival rates among ELBW and VLBW were 47.8% and 88.7%, respectively. ROP affected 48.9%of ELBW infants and 18.2%of VLBW babies. Threshold disease occurred in 21 patients, 15 of whom were born weighing <1000 g. Only 2.3%of the neonates born with more than 1000 g developed treatable disease. GA, birth weight, use of indomethacin and erythropoietin, blood transfusions, and intraventricular haemorrhage were associated with ROP. Most important adjusted risk factors were BW and use of erythropoietin.11
- In a prospective cohort observational study conducted in KEM Hospital, Pune by Sudha Chaudari et al, a total number of 552 infants were screened for ROP in the NICU from2000 to 2006. Their BW ranged from 550-2499g (mean =1306±267g). The GA ranged from 26-37 wks (mean = 31.4±2.2 wks). The incidence of ROP in 58 ELBW infants was 36.2%, in the 381 VLBW infants it was 23.6% and was 11.4% in 105 infants weighing 1500-1999g. No ROP was seen in infants with BW 2000gand GA > 36 weeks. In 116 infants, both eyes were affected. In 7 infants, only one eye was affected. Laser photocoagulation was done in 41 (33.3%) infants out of the 123 infants having ROP. More than one laser was needed in 9 infants. An effort was made to recall all children who had undergone laser therapy at the age of 3 years. Out of 552 children, 4 were lost to follow up, 22 had a complete ophthalmic checkup (53.6%), 10 had myopia and needed glasses and one had amblyopia, 9 had completely normal structural and visual outcome, 2 had poor outcome (9%), 1girl had retinal detachment and is blind in one eye, and another boy had retinal detachment in both eyes and is totally blind.12
To study the incidence, risk factors, clinical profile of ROP in preterm neonates.
7. / MATERIALS AND METHODS:
7.1 Source of data:
Preterm babies admitted to NICU, KIMS, Hubli over a period of 1 year(01-12-2012 to
30-11-2013) with a diagnosis of ROP.
7.2Type of the study:
Prospective Observational hospital based time bound study.
7.3Inclusion criteria:
Preterm babies admitted to NICU, KIMS with gestational age ≤35wks or Birth weight
<2000g.
7.4Exclusion criteria:
Congenital cataract, hazy cornea, abnormal anterior chamber.
Consent not given
7.5Methods of collection of data:
- After obtaining consent, data regarding history, BW, GA and correlation between BW and GA (weight for GA) and complaints related to babies will becollected.Risk factors will be reviewed and managed as per the standard protocols on day to day basis.First ophthalmic examination for all surviving preterm babies satisfyinginclusion criteria will be done between 3 to 6 weeks of postnatal age on every Tuesday to collect information on ROP. Further follow up screening will be considered as per the staging.
- Infants with normal vascularisation upto the periphery were not examined again. Those with ROP were examined every week or 2 weeks till regression occurs or till they reached threshold (any stage 3 ROP with plus disease with 5 contiguous clock hours of disease or a total 8 noncontiguousclock hours in zone 1 or 2) for laser treatment.
- RETCAM machine is used for screening and therapy (CLARITY COMPANY)
Yes,The following investigations will be done in all cases from the day of admission as and
When required. Those are like:
- Complete haemogram
- Random blood sugar
- Urea and creatinine
- Chest X ray
- Other investigations like blood culture, CT scan, USG abdomen, arterial blood gas (ABG) analysis, CSF analysis will be done in selected cases to find the etiology and risk factors.
7.4?
“Yes”, ethical clearance has been obtained.
Statistical analysis
Results will be analyzed by usingSPSS version 10.0, chi-square test or fischer’s exact test,
multiple logistic regression analysis.Student‘t’ test for analyzing difference between means.
8. / LIST OF REFERENCES
- Cloherty J P, Eichenwald E C, Hansen A R, Stark A R. Manual of Neonatal Care.7th ed. New Delhi : Wolters Kluwer Pvt Ltd ; 2012. Chapter 64, Retinopathy of Prematurity;p.840-45.
- Chawla D, Agarwal R, Deorari A, Paul VK, P Chandra,RV Azad. Retinopathy of prematurity. AIIMS- NICU protocols 2010.
- Gilbert C, Foster A. Blindness in children: control priorities and research opportunities.Br JOphthalmol . 2001 May; 85:p.1025-7.
- Zin AA, Moreira MEL, Bunce C, Darlow BA and Gilbert CE.Retinopathy of Prematurity in 7 Neonatal Units in Rio de Janeiro: Screening:Criteria and Workload Implications. Official journal of the American Academy of Pediatrics.2010 July; 126:p. e410-17.
- Azad R. Retinopathy of prematurity-a giant in the developing world. Indian paediatrics.2009 March;46: p.211-2.
- Rekha S and Battu RR .Retinopathy Of Prematurity: Incidenceand Risk Factors.Indian Pediatrics. 1996 Dec; 33:p.999-1003.
- Pardeep K, Sankar MJ, Deorari A, Azad R, Chandra P, Agarwal R, Paul VK. Risk Factors for Severe Retinopathy of Prematurity in Preterm Low Birth Weight Neonates. Indian J Pediatr .2011July; 78:p.812–6.
- Shah PK, Narendran1 V, Kalpana N and Gilbert C.Severe Retinopathy of Prematurity in Big Babies in India: History Repeating Itself?Indian Journal of Pediatrics.2009 August;76:p.801-4.
- Taqui AM, Syed R, Chaudhry TA, Ahmad K, Salat MS.Retinopathy of Prematurity: Frequency and Risk Factors in a Tertiary Care Hospital in Karachi, Pakistan,.J Pak Med Assoc. 2008 April; 58:p.86-90.
- Sharan R, Jha AK,Bhusan B and Nath S. Retinopathy of Prematurity-Experience from a Secondary Care Center.Indian pediatrics. 2012 August;49:p. 675.
- Filho JBF, Eckert GU, Procianoy L, Barros CK, Procianoy RS .Incidence and risk factors for retinopathy of prematurity in very low and in extremely low birth weight infant in a unit based approach in Southern Brazil. Clinical study.2006 Dec: p.1-6.
- Chaudhari S, Patwardhan V, Vaidya U, Kadam S, Kamat A. Retinopathy of prematurity in a tertiary care center – incidence, risk factors and outcome. Indian Pediatr.2009;46:p.219-24.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / RECOMMENDED FOR THE STUDY
11. / NAME AND DESIGNATION
11.1 GUIDE / Dr.PRAKASH K WARI
PROFESSOR
DEPARTMENT OF PEDIATRICS
KIMS, HUBLI.
11.2 SIGNATURE
11.3 CO-GUIDE / .
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT / Dr. T A SHEPUR
PROFESSOR AND HEAD
DEPARTMENT OF PEDIATRICS
KIMS HUBLI.
11.6 SIGNATURE
12. / 12.1 REMARKS OF
CHAIRMAN AND
PRINCIPAL
12.2 SIGNATURE