PERINATOLOGY • Vol 24 • No. 1 • May–Aug 2023 • 3 Research Article Datta M, et al. Determinants of Severe Neonatal Jaundice their venous blood total serum bilirubin (TSB) level at admission. Inclusion and exclusion criteria Inclusion criterion for cases was TSB level ≥ 15 mg/dL at admission, and for controls, TSB level 10 to 14.9 mg/dL. Neonates with major congenital anomalies were excluded from the study. Sample size calculation Considering 34% delayed diagnosis of neonatal jaundice based on data from previous studies, type 1 error of 5%, and power of 75%, the minimum sample size was 125 cases.8,9 The hypothetical delayed diagnosis among controls was set at 20%. Cases and controls were enrolled at a ratio of 1:1.5. So, 189 controls were recruited by Fleiss’ continuity correction method of sample size calculation. The sample size was calculated using the OpenEpi software version 3.01.8 Thus, the target sample size was 125 cases and at least 189 controls. Study procedure Data were collected using a predesigned schedule. Variables assessed were mean TSB levels for both groups; demographic variables such as age at admission, sex, maternal age and education, and family income; perinatal factors such as parity, known maternal risk factors (obstetric or medical risks), mode of delivery, gestational age, birth weight, and early initiation of breastfeeding (EIBF); service utilization factors such as the number of antenatal care (ANC) visits, distance to the nearest public health facility, place of delivery, whether Matri Yan (a 24 × 7 transport facility run by the West Bengal government, that can be availed for care during pregnancy, delivery, and care of sick neonates) was availed; and the interval between the diagnosis of jaundice and the neonate’s admission and variables related to the severity of jaundice. A minimum of 5 ANC visits are mandated as per the current guidelines—registration, 3 visits across the second and third trimesters, and 1 additional visit as per the Pradhan Mantri Surakshit Matritva Abhiyan (an ANC program run by the Government of India).10 Bilirubin level was estimated using the Van den Bergh test. Venous blood bilirubin level of 15 mg/dL is the accepted cutoff level for categorizing the severity of neonatal jaundice; the high level of bilirubin is considered to be pathologic due to its association with kernicterus.11 However, this cutoff is not absolute, and therapeutic interventions such as phototherapy and exchange transfusion would be necessary to lower the bilirubin level, which depends on the gestational age, body weight, and known high-risk factors. EIBF was defined as the initiation of breastfeeding within 1 hour of vaginal delivery and 4 hours of cesarean delivery. Statistical analyses Mean and standard deviation were calculated for neonatal age at admission and TSB. For all the other variables, frequency and proportion of observations in the subcategories were calculated. Crude odds ratio (COR) and 95% confidence interval (CI) were calculated to estimate and compare the risks of jaundice in cases and controls. As COR is estimated for dichotomous categories, some variable categories were merged. SPSS version 19.0 for Windows (IBM Corp, Armonk, NY, USA) was used for all the statistical analyses. Results A total of 327 neonates were included in the study— 125 cases and 202 controls. The mean TSB level in cases was significantly higher than that in the controls (21.98 vs 12.2 mg/dL, respectively). The onset of jaundice was observed to be between days 2 and 7 of life, in most neonates in both the groups. Of the 327 neonates, home remedies and medications were tried in 187 (57.2%) neonates prior to hospital admission. There was a need for exchange transfusion in 64 (19.6%) neonates (Table 1). The median age at admission was 4 days for cases and 6 days for controls. Table 2 presents a comparison of the demographic and socioeconomic risk factors among the
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