Incidence and risk factors of retinopathy of prematurity in Goa, India: a report from tertiary care centre
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International Journal of Contemporary Pediatrics Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234 http://www.ijpediatrics.com pISSN 2349-3283 | eISSN 2349-3291 DOI: http://dx.doi.org/10.18203/2349-3291.ijcp20192017 Original Research Article Incidence and risk factors of retinopathy of prematurity in Goa, India: a report from tertiary care centre Sarvesh Kossambe, Shilpa Joglekar, Annely D’Lima*, M. P. Silveira Department of Pediatrics, Goa Medical College, Goa, India Received: 13 February 2019 Accepted: 08 March 2019 *Correspondence: Dr. Annely D’Lima, E-mail: annelydlima@yahoo.com Copyright: © the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. ABSTRACT Background: To report the incidence and risk factors leading to the development of retinopathy of prematurity (ROP) from a tertiary care center in the western Indian state of Goa, India. Methods: This was a prospective observational study carried out in a level II neonatal intensive care unit (NICU) for a period of 18 months. Babies born at < 34 weeks’ gestation and having a birth weight of
Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234 either laser photocoagulation or intravitreal anti-VEGF Parameters recorded at the time of study enrollment were injections.9 gestational age, gender, birth weight, maternal complications, APGAR score at birth, fetal distress, The incidence of ROP in India has been reported over the respiratory distress syndrome (RDS), and congenital past 2 decades, with a reducing trend in the incidence malformations detected at birth. Oxygen administration across India. The reported incidence in India varies was performed via hood, CPAP or intubation as required between 38%-51.9% among premature and low birth- and continuous monitoring of oxygen saturation (SpO2) weight babies.10-12 In addition to low birth weight and was done by a pulse oximeter. Details of oxygen gestational age, other risk factors implicated for the administration immediately after birth or anytime during development of ROP include a high concentration of the NICU stay were also recorded. Additionally, the oxygen therapy, respiratory distress syndrome, apnea, partial pressure of oxygen (PaO2) and partial pressure of sepsis, blood transfusions, and anemia.13,14 carbon dioxide (PaCO2) were also measured using arterial blood gas estimation. This study was conducted at a level II NICU in a tertiary care center which is a part of a large multispecialty Statistical analysis government general hospital. Here, all preterm babies are routinely screened for the presence of ROP. Although Considering an incidence of 19.7% obtained from our there are well-documented studies on the incidence of prior pilot study, the total sample size required for the ROP from northern, eastern and southern India, there is study was 240 babies. Data were analyzed with a scant data from western India. Specifically, there is no computerized statistical package for social sciences 19 data on the incidence of ROP from Goa. In this study, (SPSS 19). A database was created using the software authors present the incidence and risk factors associated and the frequency of variables was obtained. Univariate with ROP over an 18-month period from a tertiary care analysis was conducted using a chi-square test to study hospital in Goa, India. the association between the categorical variables and outcome. METHODS RESULTS The study was approved by the institutional review board and was conducted as per the tenets of the declaration of A total of 244 babies fulfilled all the inclusion criteria Helsinki. Informed consent was obtained from all the and were screened for ROP as detailed above. Thirty- parents of the neonates enrolled in the study after seven (74 eyes) of the 244 babies (15.16%) developed explaining the nature of the study. This was a prospective ROP of which 14 babies (28 eyes) (5.73%) developed observational study conducted for a period of 18 months threshold ROP requiring laser photocoagulation therapy. in a level II NICU. All neonates weighing ≤1500gm In the remaining 23 babies, the retinopathy regressed and/or with a gestation ≤ 34 weeks admitted to the NICU spontaneously with complete vascularization (Figure 1). were included in the study. Infants with lethal congenital anomalies were excluded. The initial examination was carried out at 4 weeks after birth or at 31 to 33 weeks’ postconceptional age, whichever was later. Following the initial examination, the retina was examined weekly or every 2 weeks based on the course and severity of ROP, till complete vascularization of the retina. Those with ROP were examined every week till regression occurred or till they reached the threshold for laser treatment. The screening was done by an ophthalmologist using a binocular indirect ophthalmoscope. Babies were swaddled for pain control. Eyes were examined with an infant speculum and a Kreissig scleral depressor, under topical anesthesia using 2% proparacaine drops. The pupils were dilated by using 5% phenylephrine hydrochloride eye drops diluted in artificial tear drops in 1:3 dilution,2 drops in each eye two or three times at an interval of 20 minutes till the pupils are fully dilated. Retinopathy was graded into Figure 1: Incidence of ROP. stages and zones as per the international classification of retinopathy of prematurity (ICROP) classification. Laser Mean gestational age of the study group was 32.05±2.20 photocoagulation was advised for infants who developed weeks and the mean birth weight was 1292.3±240.2 gm. threshold disease as per ICROP classification. Neonates with threshold ROP had a significantly lower birth weight (1067.3±185 gm) compared to those with International Journal of Contemporary Pediatrics | May-June 2019 | Vol 6 | Issue 3 Page 1229
Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234 ROP which spontaneously regressed (1308.9±309 gm) The presence of maternal risk factors like pregnancy and no ROP (1305.7±228 gm) (p=0.036). induced hypertension/ pre-eclampsia, premature rupture of membranes for more than 18 hours, symptoms Similarly, those with threshold ROP requiring laser suggestive of urinary tract infections and photocoagulation had a significantly lower gestational chorioamnionitis and placental abruption and their age at birth (29.4±2 weeks) compared to those with ROP association with the occurrence of ROP were analyzed which spontaneously regressed (31.3±2 weeks) and no using univariate analysis by chi-square test. The P-values ROP (32.3±2 weeks) (p=0.001) (Table 1). obtained for each were pregnancy induced hypertension/ pre-eclampsia (0.14), premature rupture of membranes Shows differences in baseline demographics between all for more than 18 hours (0.41), symptoms suggestive of babies, those with any ROP (which includes all cases of urinary tract infections (0.83), chorioamnionitis (0.98) ROP) and threshold ROP (which includes those cases of and placental abruption (0.02). ROP which required laser photocoagulation). Table 1: Association between ROP and demographic risk factors (univariate analysis). Characteristics -Demographic Outcome P value Total babies screened Any ROP Threshold ROP (n=14) (n=244) (n=37) Gender Male 127 (52%) 21 (57%) 7 (50%) 0.671 32 weeks 99 (40%) 9 (24%) 1 (7%) 1500 gm 23 (9%) 6 (16%) 0 SGA ≤SD) 173 (77%) 24 (65%) 9 (64%) Weight for AGA 54 (22%) 11 (30%) 4 (29%) 0.804 gestational age LGA (≥2SD) 17 (1%) 2 (5%) 1 (7%) *Statistically significant (p28days 1 (7days 22 (9%) 9 (24%) 7 (50%) International Journal of Contemporary Pediatrics | May-June 2019 | Vol 6 | Issue 3 Page 1230
Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234 Table 3: Comparison of arterial blood gas levels. ABG levels Outcome P value Total babies screened Any ROP Threshold ROP (n=244) (n=37) (n=14) Not required 108 (44%) 4 (11%) 0 Highest FiO2 0.5 98 (40%) 25 (67%) 12 (86%) No 107 (44%) 5 (14%) 1 (7%) Max SO2 (%) >95 136 (56%) 32 (86%) 13 (93%) 0.002*
Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234 oximetry and higher PaO2 values on ABG. These Oxygen therapy, its duration (>7 days) of administration neonates also had significantly higher incidences of and higher FiO2 (FIO2>0.5) had a significant association hyperoxia, and hypercapnia noted on arterial blood gas with ROP in present study. Present study has shown that (Table 3). hyperoxia (PaO2>70mmHg), hypoxia (PaO2
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