PERINATOLOGY • Vol 24 • No. 1 • May–Aug 2023 • 9 Research Article Gupta T, et al. The Need for Mandatory Newborn Screening in India 2. The natural history of the condition should be well understood. 3. The condition should be detectable at an early age. 4. Treatment for the condition at an early stage should be beneficial. 5. A suitable test should be devised for early detection. 6. The test should be acceptable. 7. Intervals for repeating the test should be available. 8. Adequate health service provision should be made for the extra clinical workload from the screening. 9. The physical and psychological risks should be less than the benefits. 10. The cost should be balanced against the benefits. Study procedure Among the neonates that were born during the study period, 396 neonates were selected for screening. The blood samples were collected using the heel prick method. This method was chosen because it is a frequently used and accepted method of collecting blood from neonates and is much easier, safer, and less painful than an arterial puncture or venipuncture. The blood samples were tested for the 4 IEM using tandem mass spectrometry. While screening neonates, many parents expressed apprehension, regarding the method of blood collection. The problems faced by the clinicians while screening neonates included parents not understanding the importance of the screening activity and not wanting their neonate to be pricked even after informing about the safety and noninvasiveness of the procedure. Some parents did not find the procedure worthy in terms of cost, although the charges were minimal and reasonable. Another significant challenge was that as many metabolic errors did not manifest symptoms at birth, parents ignored or overlooked the importance of these tests. Because of strict protocols of COVID-19, the number of patients visiting the hospital decreased relatively, due to which the number of deliveries also reduced, which directly affected the rate of screening done at the hospital during this period. Statistical analyses Data were analyzed at an aggregate level using Python. Categorical data were represented in the form of frequencies and proportions, and continuous data were represented as mean and standard deviation. Results A total of 396 neonates were selected for the study. The demographic profile of the neonates enrolled in the study is shown in Table 1. Table 1. Demographic Profile of the Neonates Characteristic Value Sex, n (%) Male 210 (53) Female 185 (46.7) Ambiguous genitalia 1 (0.3) Birth Weight, kg Average birth weight, kg, mean (SD) 2.88 (0.47) 95% lower confidence interval for mean 2.83 95% upper confidence interval for mean 2.93 Gestation, wk Average gestation, wk, mean (SD) 37.48 (1.12) 95% lower confidence interval for mean 37.37 95% upper confidence interval for mean 37.59 Gestational Age of the Neonates at Birth, n (%) Preterm 45 (11.4) Term 351 (88.6) Single/Twin, n (%) Single 371 (93.7) Twin 25 (6.3) The neonates were screened for 4 major IEM—G6PD deficiency, CAH, CH, and CG. The screening results showed that in these neonates, G6PD deficiency was more prevalent (2.27%) than the remaining 3 disorders. The prevalence of CAH and CH was 0.25%, while that of CG was 0.51% (Figure 1). From October 2018 to December 2021 (38 mo), 724 neonates were delivered in our hospital, of which 396
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