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
Kossambe S et al. Int J Contemp Pediatr. 2019 May;6(3):1228-1234

of prematurity was shown in human infants in a clinical             4.    Gilbert C, Foster A. Childhood blindness in the
study in 2009.25 Low serum IGF-1 after preterm birth is                   context of VISION 2020: the right to sight. Bull
associated with poor postnatal growth and retinopathy of                  World Health Organization. 2001;79:227-32.
prematurity is also affected by immaturity, increased               5.    Cryotherapy for retinopathy of prematurity
metabolic rate, insufficient nutrition, and concomitant                   cooperative group. Multicenter trial of cryotherapy
illness, which could result in a vicious circle whereby                   for retinopathy of prematurity: preliminary results.
nutrition is poorly assimilated and both general and                      Pediatr. 1988;81(5):697-06.
vascular growth are impaired during the first few weeks             6.    Early treatment for retinopathy of prematurity
of life.                                                                  cooperative group. The incidence and course of
                                                                          retinopathy of prematurity: findings from the early
CONCLUSION                                                                treatment for retinopathy of prematurity study.
                                                                          Pediat. 2005;116(1):15-23.
In conclusion, the incidence of any stage of ROP in                 7.    Fielder AR, Shaw DE, Robinson J, Ng YK. Natural
present study, in premature neonates born at gestation 34                 history of retinopathy of prematurity: a prospective
weeks or less and/or birth weight 1500 gm or less was                     study. Eye. 1992;6(3):233.
15.16%. The incidence of threshold ROP requiring laser              8.    Darlow BA. Incidence of retinopathy of prematurity
photocoagulation therapy was 5.73%. To the best of our                    in New Zealand. Archives Dis Childhood.
knowledge, this is the first study in Goa, that has reported              1988;63(9):1083-6.
on the incidence and risk factors of ROP. The merits of             9.    Network S, Carlo WA, Finer NN, Walsh MC, Rich
the study were a relatively large sample size, reporting on               W, Gantz MG, et al. Target ranges of oxygen
many aspects of oxygen delivery including assisted                        saturation in extremely preterm infants. N Engl J
ventilation, duration of oxygen delivered and associating                 Med. 2010;362(21):1959-69.
ROP risk with arterial blood gas levels. The limitations of         10.   Gopal L, Sharma T, Ramachandran S,
the study are the lack of photographic imaging of ROP                     Shanmugasundaram R, Asha V. Retinopathy of
due to lack of availability of a RetCam at our institution.               prematurity: a study. Indian J Ophthalmol.
Judicious use of oxygen, correct ventilation strategies,                  1995;43:59-61.
proper transfusions guidelines, control of sepsis, early            11.   Charan R, Dogra MR, Gupta A, Narang A. The
initiation of enteral feeds and adequate nutrition may help               incidence of retinopathy of prematurity in a neonatal
prevent the development of ROP. All premature babies                      care unit. Indian J Ophthalmol. 1995;43:123-6.
and those having predisposing risk factors should be                12.   Varughese S, Jain S, Gupta N, Singh S, Tyagi V,
regularly screened for ROP till complete vascularization                  Puliyel JM. Magnitude of the problem of
of the retina. This will help in early diagnosis and timely               retinopathy of prematurity. experience in a large
treatment with laser photocoagulation and will contribute                 maternity unit with a medium size level-3 nursery.
to preventing blindness.                                                  Indian J Ophthalmol. 2001;49:187-8.
                                                                    13.   Penn JS, Henry MM, Wall PT, Tolman BL. The
ACKNOWLEDGEMENTS                                                          range of PaO2 variation determines the severity of
                                                                          oxygen-induced retinopathy in newborn rats. Invest
Authors would like to thank Sengupta’s Research                           Ophthalmol Visual Sci. 1995;36(10):2063-70.
Academy, Ms. Nachninolkar Pallavi, Lecturer in                      14.   Chaudhari S, Patwardhan V, Vaidya U, Kadam S,
Biostatistics, Department of Community Dentistry, Goa                     Kamat A. Retinopathy of prematurity in a tertiary
Dental College and Hospital.                                              care center- incidence, risk factors and outcome.
                                                                          Indian Pediatr. 2009;46:219-4.
Funding: No funding sources                                         15.   Gupta VP, Dhaliwal U, Sharma R, Gupta P, Rohatgi
Conflict of interest: None declared                                       J. Retinopathy of prematurity-risk factors. Indian J
Ethical approval: The study was approved by the                           Pediatr. 2004;71(10):887-92.
Institutional Ethics Committee                                      16.   Kumar P, Sankar MJ, Deorari A, Azad R, Chandra
                                                                          P, Agarwal R, et al. Risk factors for severe
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