RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA, BANGALORE
(ANNEXURE II) PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. Name of the candidate : Dr. MADHU B JAGALASAR VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
2. Name of the institution : VYDEHI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
3. Course of study and subject : M.D. PAEDIATRICS
4. Date of admission to course : 25 May 2012
5. Title of the topic : A Study Of Retinopathy Of Prematurity With Special Reference To Risk Factors In Infants Admitted to V.I.M.S.&R.C.,Bangalore
6. BRIEF RESUME OF INTENDED WORK: ABSTRACT Need For The Study
Retinopathy of prematurity (ROP), previously known as Retrolental Fibroplasia (RLF), is an eye disease that affects prematurely-born babies. It is thought to be caused by disorganized growth of retinal blood vessels which may result in scarring and retinal detachment. ROP can be mild and may resolve spontaneously, but it may lead to blindness in serious cases.1
Advances in management and care of newborns, especially preterms and better survival of preterm babies has increased the population of babies at risk for developing ROP. Oxygen has been both a vital therapeutic tool and an agent of harm in Neonatal care. There has been a trend of using lower oxygen saturation targets in extremely low gestational age infants to minimize retinopathy of prematurity (ROP) based largely on small uncontrolled series and retrospective reviews. Now, large randomized trials have shown that while such targets reduce severe ROP, mortality is increased significantly. Until current trials and follow-up are completed, it is prudent to avoid saturation targets <89%. 2
Recent studies done by Monuj Triven Bashambu, Monika Bhola, Michele Walsh on “Evidence for oxygen use in preterm infants ” (March 2012) at Rainbow Babies & Childrens Hospital, Case Western Reserve University suggest preterm infants should be resuscitated with blended oxygen (30–90%) targeted to avoid hyperoxia. Later, saturation management remains uncertain. Until ongoing trials and follow-up are complete, it is prudent to avoid saturation of 85–89%. 2
This prospective clinical study is undertaken to determine the incidence and risk factors for the development of ROP in our neonatal unit at V.I.M.S&R.C., Bangalore. Objectives
1. To determine the incidence of ROP. 2. To study the clinical profile, with special reference to the correlation between ROP and : A. Gestational age B. Birth weight C. Respiratory distress syndrome needing oxygen D.sepsis
Review Of Literature
As such, all preterm babies are at risk for ROP, primarily affecting premature infants weighing about 1500 grams or less that are born before 32 weeks of gestation. Both oxygen toxicity and relative hypoxia can contribute to the development of ROP along with Oxygen exposure, apnea, septicemia ventilation, respiratory distress syndrome , blood transfusion, hypoxia, hyperoxia, hypercarbia, hypotension and intracranial hemorrhage are well recognized risk factors of ROP.3
Today, with advances in neonatal care, smaller and more premature infants are being saved. These infants are at a much higher risk for ROP. Not all babies who are premature develop ROP. There are approximately 3.9 million infants born in the U.S. each year; of those, about 28,000 weigh 2¾ pounds or less. About 14,000–16,000 of these infants are affected by some degree of ROP. The disease improves and leaves no permanent damage in milder cases of ROP. About 90 percent of all infants with ROP are in the milder category and do not need treatment. However, infants with more severe disease can develop impaired vision or even blindness. About 1,100– 1,500 infants annually develop ROP that is severe enough to require medical treatment. About 400–600 infants each year in the US become legally blind from ROP.4 Palmer and colleagues showed that African Caribbean infants are less likely to develop ROP than their Caucasian counterparts.5 The incidence is slightly greater in male infants than in female infants.6 Multiple gestation may be taken as an independent risk factors for retinopathy of prematurity causation.Sicker the twin infant is,the more are the chances that he/she will develop ROP.7
Another study showed atrend towards clinical significance with 4 systemic conditions,which were more commonly observed in the cohort with ROP compared to the group without.Tese were respiratory distress(26.5% vs 14.5%),oxygen therapy(18.4% vs 8.7%),neonatal jaundice(32.7% vs 23.2%) and clinically proven sepsis(22.4% vs 15.9).8 Infants with ROP are considered to be at higher risk for developing certain eye problems later in life, such as retinal detachment, myopia (nearsightedness), strabismus (crossed eyes), amblyopia (lazy eye), and glaucoma. In many cases, these eye problems can be treated or controlled.9 Current treatment options are expensive and can have potentially serious complications, thus prevention is still the best strategy available at present to avoid visual deficits caused by ROP.10 Traditional modalities of treatment included cryotherapy and laser therapy, which were laborious and required special training. Hence, research is on way to find novel treatment modalities directed at various levels of pathogenesis for this blinding disease. We reviewed the published and unpublished literature on newer methods of ROP management. The pathogenesis of ROP has been studied with respect to the mediators of angiogenesis. Anti vascular endothelial growth factor (Anti-VEGF) therapy has been extensively studied and the studies have demonstrated its promising role early stages of ROP. The role of Insulin like growth factor (IGF), Granulocyte colony stimulating factor (GCSF), and June kinases (JNK) inhibitors are being studied by various researchers across the world. Gene therapy holds promise in the reversal of ROP changes.11
Methodology
Source Of Data: Neonates with gestational age ≤ 35 weeks and/or birth weight ≤ 1800 gm and the babies admitted into the NICU at V.I.M.S.
Method Of Collection Of Data: All infants will be examined regularly by the ophthalmologist at 1-2 weeks intervals from the 4th postnatal week onwards. Clinical examination is done after full dilation using tropicamide drops 1%. Risk factors and details of ROP will be recorded in the proforma.Babies will be followed once fortnightly upto 4 visits.Data will be analyzed by SPSS(Statistical Package for Social Sciences) statistical package.
Statistical Method: Descriptive statistics including the mean and standard deviation for numerical variables, and the percentage of different categories for categorical variables. The prevalence rate of ROP will be described in simple proportion. Group comparisons will be done by the Chi-squared (χ²) test or Fisher's exact test for categorical variables. A logistic regression model will be performed and obtained for the risk factors using univariate and multivariate analysis.
Inclusion Criteria: A) Babies weighing lesser than 1800 grams B) Babies born at ≤ 35 weeks of gestation C) Selected pre-term infants with birth weight between 1800-2500 grams or gestational age of more than 35 weeks with sickness like need of cardiorespiratory support,prolonged oxygen therapy, apnea of prematurity, anaemia needing blood transfusion and neonatal sepsis or believed by their attending pediatrician or neonatologist to be at high risk.
Exclusion criteria: A. All babies with severe chromosomal anamolies. B.Babies with birth weight above 1800 and gestational age above 35weeks.
Q) Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so please describe briefly.
Yes. Binocular indirect ophthalmoscopy will be done with the consent of the parents.
Q) Has ethical clearance been obtained from your institution in case of 7.3?
Yes. Copies enclosed. List Of References:
1) http://en.wikipedia.org/wiki/Retinopathy_of_prematurity 2) Triven Bashambu, M., Bhola, M. and Walsh, M. (2012), Evidence for oxygen use in preterm infants. Acta Paediatrica, 101: 29–33. doi: 10.1111/j.1651-2227.2011.02548.x 3) Azad R, Chandra P, Patwardhan SD, Gupta A. Importance of the 'third criterion' for retinopathy of prematurity screening in developing countries. J pediar Ophthalmol strabismus 2009;46:332-4; quiz 5-6. 4) National Eye Institute, USA. http://www.nei.nih.gov/health/rop/rop.asp 5) Palmer EA, Flynn JT, Hardy RJ, et al. Incidence and early course of retinopathy of prematurity. The Cryotherapy for Retinopathy of Prematurity Cooperative Group. Ophthalmology. Nov 1991;98(11):1628-40. [Medline]. 6) Mounir Bashour, MD, CM, FACS, FRCS(C), Ph.D http://emedicine.medscape.com/article/1225022-overview#a0101 7) Vikrant sood,Harish Chellani,Sugandha Arya,B.P.Gullani(Dept of paediatrics) Vardhaman Mahavir Medical College and Safdarjung Hospital,New Delhi.changing Spectrum of ROP and Variations among siblings of multiple gestation.Indian Journal Of Paediatrics(July 2012)79(7):905-910 8) Bhavana Huggi,Anand Vinekar,Narendra Datti et al.Retinopathy Of Prematurity in rural Neonatal Intensive Care Unit in South India-A Prospective study.Indian Journal of Paediatrics(July 2012)79(7):911-915 9) National Eye Institute, USA. http://www.nei.nih.gov/health/rop/rop.asp 10) Gilbert C, Foster A. Childhood blindness in the context of vision 2020- the right to sight . Bull World Health Organ 2001; 79 : 227-32. 11) HS Niranjan, Naveen Benakappa, KR Bharath Kumar Reddy, Shivananda and M Vasudeva Kamath (Division of Neonatology, Indira Gandhi Institute of Child Health, Bangalore, Karnataka). Retinopathy of Prematurity –Promising Newer Modalities of Treatment. Indian Pediatr 2012;49: 139-143. Signature Of the Candidate:
Remarks Of the Guide:
Name and Designation of Guide: Dr. M.L.Siddaraju Professor Of Department of Pediatrics, V.I.M.S.&R.C.
Signature:
Head of the Department: Dr. M G Javali Professor and HOD Department of pediatrics V.I.M.S.&R.C.
Signature:
Remarks of the Principal:
Signature:
Remarks of the Chairman:
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