https://doi.org/10.36570/jduhs.2024.3.

2346
JDUHS

ORIGINAL ARTICLE
Prevalence and Associated Risk Factors of Retinopathy of Prematurity in
Preterm Infants: A Cross-Sectional Study
Manisha Kumari, Mohsina Noor Ibrahim, Versha Rani Rai, Zubair Khoso, Roshia Parveen, Ajea Rani
National Institute of Child Health, Jinnah Sindh Medical University, Karachi, Pakistan.
Correspondence to: Dr. Manisha Kumari, Email: [email protected], ORCiD: 0009-0004-4799-4206
ABSTRACT
Objective: To determine the prevalence of Retinopathy of Prematurity (ROP) and its associated risk factors in
preterm infants at the National Institute of Child Health (NICH), Karachi, Pakistan.
Methods: This cross-sectional study was conducted in the neonatal intensive care unit (NICU) department of
NICH, Karachi, Pakistan from October 2020 to March 2021. The study included preterm infants with a gestational
age under 32 weeks, admitted to the NICU at the NICH, Karachi. ROP was diagnosed by indirect ophthalmoscopy
following pupil dilation, performed by a trained ophthalmologist. Risk factors were assessed based on preterm
infants' age, gestational age, residence, gender, maternal education, sepsis, respiratory distress syndrome
(RDS), anemia, oxygen dependency duration, and mechanical ventilation.
Results: Of total 310 preterm infants, the mean age was 5.73 ±1.49 days. There were 184 (59.3%) males and 126
(40.6%) females. ROP was observed in 139 (44.8%) preterm infants. Binary logistic regression indicated
significantly increased ROP risk in infants of illiterate mothers (aOR 3.31, 95% CI 1.08 to 10.17, p-value 0.036), those
with family income ≤ 45,000 rupees (aOR 3.70, 95% CI 1.40 to 9.76, p-value 0.008), and reduced risk in female
infants (aOR 0.12, 95% CI 0.04 to 0.31, p-value <0.001), infants on oxygen ≤ 4 days (aOR 0.04, 95% CI 0.01 to 0.12, p-
value <0.001), and NICU stay ≤ 12 days (aOR 0.02, 95% CI 0.01 to 0.08, p-value <0.001).
Conclusion: Nearly half of the preterm neonates were affected by ROP, with contributing factors including
maternal illiteracy, low family income, prolonged oxygen dependency, and extended NICU stays.
Keywords: Body Mass Index, Circuit Training, High Intensity Interval Training, Obesity, Overweight.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http:// creative commons.
org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

INTRODUCTION smaller infants, which, while improving survival rates,

4
has also led to an increased incidence of ROP. The
Retinopathy of Prematurity (ROP) is a major World Health Organization and the International
contributor to preventable blindness among preterm Agency for the Prevention of Blindness recognize ROP
infants worldwide. It is particularly prevalent in middle- as a major public health issue, emphasizing the
5
and low-income countries, where the burden is importance of early detection and timely intervention.
exacerbated by the limited availability and accessibility Key risk factors for ROP include low gestational age,
1,2
of advanced neonatal care facilities. The incidence of low birth weight, prolonged oxygen dependency, and
ROP in these regions remains alarmingly high due to comorbidities such as sepsis and respiratory distress
factors such as inadequate monitoring of oxygen syndrome (RDS). These factors significantly increase
therapy, suboptimal preterm care, and insufficient the susceptibility of preterm infants to developing this
screening programs.1,2 It is a vascular proliferative 6-8
condition. Additionally, the use of mechanical
disorder affecting the underdeveloped retina in ventilation-a common intervention in neonatal
preterm infants, particularly those with low birth intensive care units (NICUs) to manage respiratory
weight or those requiring supplemental oxygen complications in preterm infants-exposes the
therapy. It arises due to disrupted vascularization of the developing retina to higher oxygen levels, further
9
retina, often exacerbated by the use of oxygen, leading increasing the risk of ROP.
to abnormal blood vessel growth and potential retinal This study was conducted in the National Institute of
detachment if left untreated.3 Advances in neonatal Child Health (NICH), Karachi, one of the largest public
care have led to the survival of increasingly younger and sector pediatric hospitals in Sindh Province, Pakistan,
J Dow Univ Health Sci 2024, Vol. 18(3): 157-163 157
Kumari et al. Prevalence and Associated Risk Factors of Retinopathy
which serves a diverse population with limited access to mydriasis using 0.5% tropicamide and 2.5% phenyle-
specialized neonatal care. Given the high rates of phrine eye drops, administered three times at 15-minute
preterm births and related complications in this setting, intervals. Binocular indirect ophthalmoscopy was
an in-depth understanding of ROP frequency and conducted with a 20 D lens. Lid speculum and scleral
associated risk factors is essential for improving depressors were utilized as standard practice to
neonatal outcomes. This study aims to determine the facilitate examination. Observations were documen-
frequency of ROP in preterm infants at NICH and to ted, noting the presence or absence of ROP and the
explore demographic, clinical, and socioeconomic risk associated stages or findings.
factors contributing to its development. Sepsis diagnosis was confirmed through positive blood
culture results for bacterial pathogens or clinical
METHODS diagnosis based on the combination of symptoms and
laboratory findings. RDS was diagnosed by observing
This cross-sectional study was conducted in the NICU signs such as grunting, flaring, chest retractions, and
department of NICH, Karachi, Pakistan from October increased respiratory rate, with confirmation by chest
2020 to March 2021. Ethical approval was obtained radiograph showing ground-glass appearance and air
from the Institutional Review Board of NICH (Reference broncho-grams. Anemia is diagnosed through
Number: 26/2020). Signed informed consent was laboratory testing, with hemoglobin levels typically
obtained from parents/guardians of preterm infants measuring below 10 g/dL in very preterm infants born at
prior to the enrolment of participants in the study. less than 32 weeks of gestation.
Parents were informed of the study's purpose, Data entry and analysis were performed using the
procedures, and potential risks and benefits. Statistical Package for Social Sciences (SPSS) version
Confidentiality of participants' information was strictly 20.0. Mean ±SD was computed for quantitative
maintained. variables like age, gestational age, and birth weight
By using OpenEPI sample size calculator taking while frequency and percentages were computed for
prevelance of ROP 28%,10 level of confidence 95%, 5% categorical variables like gender, residential status,
margin of error. The estimated sample size was 310. mothers educational level, family income, oxygen
Eligible participants were selected using a consecutive dependency days, NICU stay, sepsis, anemia, RDS, and
sampling method. The inclusion criteria for this study mechanical ventilation. Inferential statistics were
required infants born preterm, specifically those with a explored using the Chi-square and Independent t-test
gestational age of less than 32 weeks and admitted to test to compare ROP with baseline and clinical
the NICU at the NICH, Karachi. Exclusion criteria characteristics of infants. The p-value of ≤0.05 was
included preterm infants who expired before considered statistically significant. Moreover, binary
undergoing the initial ROP examination, those whose logistic regression was applied to all those variables
guardians declined consent for participation, infants found significant in the Chi-square/Fisher exact
without a history of oxygen therapy during their NICU contingency table. Both univariable and multivariable
stay, infants with major congenital anomalies, as these logistic regression were applied. p-value of ≤0.05 was
may complicate ROP screening and outcomes, and considered statistically significant. Moreover, binary
infants with severe systemic infections or conditions, logistic regression was applied to all those variables
which might interfere with ROP development or found significant in the Chi-square/Fisher exact
screening accuracy. contingency table. Both univariable and multivariable
Data on demographics, including age, gestational age, logistic regression were applied.
birth weight, gender, and residential status, were
collected from medical records and recorded on a RESULTS
structured proforma. ROP is defined as an abnormal
development of retinal blood vessels in preterm Of total 310 preterm infants, the mean age, gestational
infants. The presence of ROP was identified through age, and birth weight were 5.73 ±1.49 days, 29.22 ±1.47
ophthalmologic examination, characterized by weeks, and 1.81 ±0.44 kg respectively. There were 184
abnormal vascular proliferation and development (59.3%) males and 126 (40.6%) females. Most of the
within the retina. The condition is classified into stages infants had family income 45,000 or above 183 (59.0%)
(1 to 5) based on the severity of retinal changes, in and their mothers were illiterate 123 (39.7%). Oxygen
accordance with established international screening dependency was ≤ 4 days in majority of the infants 160
guidelines. ROP screening was performed under (51.6%), however their NICU stay was more than 12 days
158 J Dow Univ Health Sci 2024, Vol. 18(3): 157-163
Kumari et al. Prevalence and Associated Risk Factors of Retinopathy
161 (51.9%). Sepsis, anemia, and RDS were observed in 75 in illiterate mothers (aOR 3.31, 95% CI 1.08 to 10.17, p-
(24.2%), 94 (30.3%), and 95 (30.6%) infants respectively. value 0.036), approximately 5 times significantly higher
Mechanical ventilation was reported in 74 (23.9%) in mothers educated upto higher secondary (aOR 4.85,
infants. 95% CI 1.40 to 9.76, p-value 0.011), 3.7 times significantly
ROP was reported in 139 (44.8%) preterm infants. A higher among infants with ≤45,000 rupees of family
significantly higher association of ROP found with income (aOR 3.70, 95% CI 1.40 to 9.76, p-value 0.008),
female infants (p-value <0.001), gestational age ≤ 30 while 88% significantly lower among female infants
weeks (p-value <0.001), maternal illiteracy (p-value (aOR 0.12, 95% CI 0.04 to 0.31, p-value <0.001), 96%
<0.001), birth weight ≤ 1.8 kg (p-value 0.014), family significantly lower among infants dependent on
income ≤ 45,000 (p-value <0.001), oxygen dependency oxygen ≤4 days (aOR 0.04, 95% CI 0.01 to 0.12, p-value
more than 4 days (p-value <0.001), and NICU stay more <0.001), and 98% significantly lower among infants
than 12 days (p-value <0.001). Furthermore, infants with stayed in NICU ≤ 12 days (aOR 0.02, 95% CI 0.01 to 0.08, p-
sepsis (p-value 0.002) and mechanical ventilation (p- value <0.001).
value <0.001) were also showed higher association of
RDS (Table 1 and 2).
DISCUSSION
Table 3 reveals binary logistic regression analysis for The frequency of ROP in our cohort of preterm infants
predicting ROP in preterm infants. At the univariate was found to be high, aligning with recent studies
11,12
level, all variables presented in Table 3 showed reporting similar prevalence in preterm infants. This
significant odds ratios. Furthermore, the findings of the high frequency underscores critical importance of ROP
multivariable analysis were presented after adjusting screening programs in NICUs, especially in settings like
the variables that were significant in the univariable Karachi, where access to comprehensive neonatal care
13-15
analysis. The risk of ROP was 3 times significantly higher can vary.

Table 1: Comparison of retinopathy of prematurity with baseline characteristics of preterm infants (n= 310)
Retinopathy of Prematurity
Variables Total p-value
Yes (n =139) No (n= 171)
Age (days) 5.73 ±1.49 5.53 ±1.29 5.90 ±1.62 0.028$*
≤5 164 81 (49.4) 83 (50.6)
0.088^
>5 146 58 (39.7) 88 (60.3)
Gender
Male 184 41 (22.3) 143 (77.7)
<0.001^*
Female 126 98 (77.8) 28 (22.2)
Gestational Age (weeks) 29.22 ±1.47 28.95 ±1.30 29.4 ±1.57 0.004$*
≤ 30 241 120 (49.8) 121 (50.2)
<0.001^*
> 30 69 19 (27.5) 50 (72.5)
Residential Status
Urban 107 53 (49.5) 54 (50.5)
0.228^
Rural 203 86 (42.4) 117 (57.6)
Maternal Education Status
Illiterate 123 79 (64.2) 44 (35.8)
Secondary or Higher Secondary 102 32 (31.4) 70 (68.6) <0.001^*
Intermediate or above 85 28 (32.9) 57 (67.1)
Birth Weight (kg) 1.81 ±0.44 1.75 ±0.47 1.85 ±0.41 0.037$*
≤ 1.8 168 86 (51.2) 82 (48.8)
0.014^*
> 1.8 142 53 (37.3) 89 (62.7)
Family Income (PKR)
≤ 45,000 127 72 (56.7) 55 (43.3)
<0.001^*
> 45,000 183 67 (36.6) 116 (63.4)
-Quantitative variables described by mean ±SD, Categorical variables described by frequencies (percentages), PKR:
Pakistani rupee
* p-value ≤ 0.05 (^Chi-Square test and $Independent t-test)
J Dow Univ Health Sci 2024, Vol. 18(3): 157-163 159
Kumari et al. Prevalence and Associated Risk Factors of Retinopathy
Table 2: Comparison of retinopathy of prematurity with clinical characteristics of preterm infants (n= 310)
Retinopathy of Prematurity
Variables Total Yes No p-value
(n =139) (n= 171)
Oxygen Dependency (days) 4.85 ±1.60 5.87 ±1.38 4.02 ±1.27 <0.001$*
≤4 160 24 (15.0) 136 (85.0)
<0.001^*
>4 150 115 (76.7) 35 (23.3)
NICU Stay (days) 12.45 ±3.41 15.28 ±2.01 10.16 ±2.48 <0.001$*
≤ 12 149 14 (9.4) 135 (90.6)
<0.001^*
> 12 161 125 (77.6) 36 (22.4)
Sepsis
Yes 75 45 (60.0) 30 (40.0)
0.002^*
No 235 94 (40.0) 141 (60.0)
Anemia
Yes 94 43 (45.7) 51 (54.3)
0.832^
No 216 96 (44.4) 120 (55.6)
Respiratory Distress Syndrome
Yes 95 47 (49.5) 48 (50.5)
0.275^
No 215 92 (42.8) 123 (57.2)
Mechanical Ventilation Applied
Yes 74 49 (66.2) 25 (33.8)
<0.001^*
No 236 90 (38.1) 146 (61.9)
-Quantitative variables described by mean ±SD, Categorical variables described by frequencies (percentages), NICU:
Neonatal intensive care unit
* p-value ≤ 0.05 (^Chi-Square test and $Independent t-test)

Our findings highlight several significant risk factors These finding highlights the need for targeted health
associated with ROP, including female gender, low education and support for mothers in similar socio-
maternal education, sepsis, and the use of mechanical demographic settings to improve neonatal health
ventilation. Mechanical ventilation along with birth outcomes. Sepsis emerged as a key contributor to ROP
weight were also reported as significant risk factors in in our study. Preterm infants with sepsis face an
previous studies.16,17 In this study, a higher prevalence of increased inflammatory response and oxidative stress,
ROP was observed in female infants. A systematic which are known to affect retinal vascular develop-
review did not find a significant association between ment.22 This result is consistent with previous studies
female gender and ROP prevalence. However, contrary indicating a strong association between systemic
to current study findings, they reported significant infections and ROP.12,23 Infection control measures and
18
association of male gender with ROP. However, it was early treatment of sepsis are essential strategies to
reported that the association between male sex and reduce this risk factor in vulnerable preterm popula-
24
severe ROP was primarily observed in cohorts from tions.
countries with high or high-middle sociodemographic This study has several limitations. First, as a single-
18
indices. Another study also reported a number of male center study conducted in a public sector hospital, the
infants who were treated for ROP were higher as findings may not be fully generalizable to other
19
compared to females. The suspicion that more male settings, especially private healthcare institutions
infants are treated for ROP than female infants has where NICU resources and protocols might differ.
been confirmed, potentially due to a known pathoph- Second, the cross-sectional design limits our ability to
ysiological fragility of male neonates.19 establish causal relationships between identified risk
Maternal education, particularly low or no formal factors and ROP. Additionally, the sample size, though
education, was another significant risk factor in the adequate for preliminary observations, may not
current study. This could be due to the reason that capture the full spectrum of factors influencing ROP
mothers with limited education may have less access to across a more diverse population. The study also relied
healthcare resources, including antenatal care, poten- on maternal recall for certain sociodemographic
tially affecting prenatal and postnatal outcomes.20,21 variables, such as educational level, which could
160 J Dow Univ Health Sci 2024, Vol. 18(3): 157-163
Kumari et al. Prevalence and Associated Risk Factors of Retinopathy
Table 3: Binary logistic regression analysis for predicting retinopathy of prematurity in preterm infants
Univariable analysis Multivariable analysis
Variables
cOR (95% CI) p-value aOR (95% CI) p-value
Gender
Male 0.08 (0.04 to 0.14) <0.001* 0.12 (0.04 to 0.31) <0.001*
Female 1 1
Gestational Age (weeks)
≤ 30 2.61 (1.45 to 4.68) <0.001* 2.31 (0.67 to 7.89) 0.181
> 30 1 1
Maternal Education Status
Illiterate 3.65 (2.03 to 6.55) <0.001* 3.31 (1.08 to 10.17) 0.036*
Secondary or Higher Secondary 0.93 (0.50 to 1.72) 0.819 4.85 (1.40 to 9.76) 0.011*
Intermediate or above 1 1
Birth Weight (kg)
≤ 1.8 1.76 (1.11 to 2.77) 0.015* 2.63 (0.98 to 7.02) 0.054
> 1.8 1 1
Family Income (pkr)
≤ 45,000 2.26 (1.42 to 3.59) <0.001* 3.70 (1.40 to 9.76) 0.008*
> 45,000 1 1
Oxygen Dependency (days)
≤4 0.05 (0.03 to 0.09) <0.001* 0.04 (0.01 to 0.12) <0.001*
>4 1 1
NICU Stay (days)
≤ 12 0.03 (0.01 to 0.05) <0.001* 0.02 (0.01 to 0.08) <0.001*
> 12 1 1
Sepsis
Yes 2.25 (1.32 to 3.82) 0.003* 0.85 (0.20 to 3.50) 0.822
No 1 1
Mechanical Ventilation Applied
Yes 3.18 (1.83 to 5.50) <0.001* 2.75 (0.63 to 11.98) 0.176
No 1 1
-NICU: Neonatal Intensive Care Unit
cOR: Crude odds ratio, aOR: Adjusted odds ratio, CI: confidence interval, *p-value ≤ 0.05

introduce recall bias. Despite these limitations, our oxygen therapy protocols and infection control in
study has notable strengths. It provides valuable data NICUs, could further aid in reducing ROP incidence.
on the prevalence and risk factors of ROP in a public Lastly, exploring the psychosocial aspects, such as
sector setting in Karachi, addressing a significant gap in maternal support and access to health education, may
local neonatal research. The use of well-defined provide comprehensive insights into modifiable risk
operational criteria for ROP, oxygen dependency, and factors, guiding more effective ROP prevention program.
other key variables strengthens the reliability of our
findings. Future research should aim to validate our CONCLUSION
findings through multi-center studies that encompass
both public and private hospitals, enhancing the This study identified ROP as a prevalent health concern,
generalizability of results. Prospective cohort studies affecting nearly half of preterm infants, underscoring
would be particularly valuable in examining causality ROP as a major health concern in neonatal care. Key risk
and temporal relationships between risk factors and factors for ROP include maternal illiteracy, low family
ROP development. Additionally, larger sample sizes income, prolonged oxygen dependency, extended
could help to identify less common risk factors and NICU stay. The findings emphasize the need for
investigate any regional variations in ROP prevalence. targeted interventions, such as improving maternal
Research on preventive strategies, including optimal education, enhancing neonatal care practices, and
J Dow Univ Health Sci 2024, Vol. 18(3): 157-163 161
Kumari et al. Prevalence and Associated Risk Factors of Retinopathy
addressing socioeconomic disparities, to lower the yearretrospective study. Earl Hum Dev 2023; 185:105844.
prevalence of ROP and improve outcomes for preterm doi:10.1016/j.earlhumdev.2023.105844
infants. 7. Martins FM, Santos AC, Neves CM, Bicho M, Guimaraes
H. Retinopathy of prematurity in eight portuguese
neonatal intensive care units: incidence, risk factors,
ETHICAL APPROVAL: The study protocol was approved
and progression-a prospective multicenter study.
by the Ethical Review Board of National Institute of Children (Basel) 2024; 11:1154.
Child Health, Karachi (Reference Number: 26/2020, doi: 10.3390/children11101154
dated: 22 October, 2020) 8. Lin YW, Chen SN, Muo CH, Sung FC, Lin MH. Risk of
retinopathy of prematurity in preterm births with
AUTHORS’ CONTRIBUTIONS: MK & MNI: Substantial respiratory distress syndrome: a population-based
contributions to the conception or design of the work. cohort study in Taiwan. Int J Gen Med 2022: 15:2149-62.
MK, VRR, ZK, RP, AR: Data acquisition, analysis and doi: 10.2147/IJGM.S344056
interpretation. MK, MNI, VRR, ZK, RP, AR: Drafting the 9. Ramirez NL, Aranda GL, Frías FJ, Tamayo TS. Risk factors
manuscript or revising it critically for important associated with retinopathy of prematurity
development and progression. Sci Rep 2022; 12:21977.
intellectual content. MNI & VRR: Provided supervision
doi: 10.1038/s41598-022-26229-4
and/or project administration. Including oversight of 10. Riaz M, Rafique S, Hina A, Bashir M, Majeed MT, Maqbol
the research activity planning and execution. All S. Frequency and risk factors of retinopathy of
authors critically reviewed and gave final approval of prematurity in preterm babies at a tertiary care hospital
the manuscript. in Lahore: Frequency and risk factors of Retinopathy of
prematurity in preterm babies. J Fatima Jinnah Med
CONFLICT OF INTEREST: All authors do not have any Univ 2019; 13:110-5. doi:10.37018/j mu.v13i3.607
conflict of interest. 11. Dani C, Coviello C, Panin F, Frosini S, Costa S, Purcaro V, et
al. Incidence and risk factors of retinopathy of
FUNDING: No Funding. prematurity in an Italian cohort of preterm infants. Ital J
Pediatr 2021; 47: 64. doi:10.1186/s13052-021-01011-w
Received: October 26, 2024 12. Yucel OE, Eraydin B, Niyaz L, Terzi O. Incidence and risk
factors for retinopathy of prematurity in premature,
Accepted: December 10, 2024
extremely low birth weight and extremely low
gestational age infants. BMC Ophthalmol 2022; 22:367.
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