Physiological Icterus of the Newborn and the Role of Liv.52

Neonatal jaundice can be a major health threat to the newborn. The present study compared the effects of Liv.52 to that of phenobarbitone with a third group serving as control, in a total of 260 newborn babies. It was found that Liv.52 pretreatment has no deleterious effect on development of icterus. Continued treatment with Liv.52 led to early disappearance of icterus. It was also safe, without side effects. INTRODUCTION Jaundice during the neonatal period is quite common. Sixty percent of terms infants and 80% of preterm infants develop jaundice (Kivlahane, C., James, E.J.P. 1984). Jaundice may lead to low motor and mental scores later in life (Bougre et al., 1967) by having a toxic effect on the brain (Odell, 1980). Certain Asian groups (Chinese, Indian and Malaysian) and some American Indians and Greeks have a higher peak of physiological jaundice (Johnson, 1975). Keeping this pathophysiology of physiological jaundice in mind, various management lines were proposed for this condition. Cremer et al., (1957) recommended exposure to sunlight; Srivastava et al., (1972) used Liv.52 drops; agar (Morrer, 1973) and cholestyramine (Micalopaulos, 1978) have also been recommended. Sircar, Bhalla and Chandu (1979) recommended the use of phenobarbital and phototherapy in combination. The present study was undertaken to compare the effects of Liv.52, an indigenous drug of The Himalaya Drug Co., to that of phenobarbitone in the management of neonatal jaundice. MATERIAL AND METHODS This work was carried out on 260 babies weighing 1150 g or more, born in S.V.B.P. Hospital of the L.L.R.M. Medical College, Meerut, during a period of seven months. Antenatal history was recorded with special reference to the use of drugs, exposure to infection and maternal diseases such as diabetes mellitus. A record of the prenatal period regarding birth asphyxia along with the history of jaundice in previous siblings was made. All children were weighed at birth and clinically assessed for the period of gestation. Of these, forty seven children were later excluded from the study. Five were cases of Rh incompatibility, three were of ABO incompatibility, for two there was history of diabetes mellitus from the mother, four had cephalhaematoma, seven had septicemia and twenty six had diarrhoea. All children were examined daily for appearance of icterus by pressing the skin of the nose and forehead in good sunlight. The time of appearance of icterus, its daily progression and disappearance were recorded. Rh and ABO blood grouping of cord blood samples of every child and blood grouping of the mothers was done. Serum bilirubin estimations including total bilirubin and conjugated and unconjugated fractions were carried out on 4 and on 8 day of life. Other investigations like hemoglobin, reticulocyte count, Coomb’s test, blood/stool culture and chest X-rays were done as and when required. The cases were divided into 3 groups. The first group consisted of 73 babies on Liv.52 drops (5 drops TDS) from the first day continued till the 8 day. The second group consisted of 65 babies who were put on phenobarbitone in a dose of 10 mg twice daily starting with the first day and continuing up to the 8 day. The third group of 75 babies served as the control. OBSERVATIONS There was no significant difference in the occurrence of icterus among the two sexes in term as well as in preterm babies as shown in Table 1. Table 1: Distribution of cases according to sex and gestation Total deliveries Cases of physiological icterus Gestation Male Female Total Male Female Total Term 70 67 137 36 31 67 Preterm 40 30 70 30 20 50 Table 2 shows the effect of parity on physiological icterus which is significant χ=47.12 (p<0.001) i.e. the incidence decreased with increasing parity. One hundred and six babies i.e. 90.6% developed physiological icterus by the 3 day, and only eleven babies i.e. 9.4% developed icterus on the 4 day as seen in Table 3. 48.36% of the cases had birth weight between 1150 g to 2500 g, while 57.64% of the children had weight of more than 2500 g. Out of the 103 children in group 1-3, 64 i.e. 62.53% developed icterus while in weight group 4 out of 110 only 53 (48.18%) developed icterus. These findings are shown in Table 4. Table 2: Distribution of cases according to parity Parity Total cases studied (213) Cases who showed physiological icterus ((117) 1 80 65 2 70 37 3 40 10 4 & greater 23 5 Table 3: Distribution of cases according to day of appearance of icterus Day of appearance of icterus Number Percentage 2 day 31 26.5 3 day 75 64.1 4 day 11 9.4 Table 4: Birth weight of children in each group Birth weight (g) Total no. (213) Percentage Liv.52 group (73) Phenobarbitone (65) Control (75) 1150-1500 25 11.75 9 7 9 1500-2000 45 21.11 14 15 16 2000-2500 33 15.50 13 10 10 >2500 110 52.60 37 33 40 t=0.1374; t=0.4123 There was no significant statistical difference (p<0.05) in the 3 groups as far as the occurrence of physiological icterus was concerned as shown in Table 5. There was no significant difference in the disappearance of icterus when the control group was compared with the liv.52-treated and phenobarbitone-treated group. These values are shown in Table 6. Table 5: Break up of cases of physiological icterus in each group Group No. of cases Cases with physiological icterus Percentage of icterus Cases without icterus Liv.52 73 36 49.3 37 Phenobarbitone 65 39 60.0 26 Control 75 42 48.0 33 χ=1.3363, p<0.05 Table 6: Depicting the day of disappearance of icterus in different groups Day of disappearance Total no. of patients Liv.52 No. of patients on Phenobarbitone Control 5 day 20 8 6 6 6 day 10 4 3 3 7 day 17 7 5 5 8 day 50 11 19 20 8-12 day 20 6 6 8 Total 117 36 39 42 Mean – 7.5 7.5641 7.6905 The mean values of serum bilirubin and indirect bilirubin on the 4 day of life did not show any significant difference between the three groups. Table 7 shows the values on day 4. Table 7: Depicting mean serum bilirubin values on the 4 day of life in different groups Serum bilirubin (Mean) Liv.52 Group (mg%) Phenobarbitone (mg%) Control (mg%) Total 5.8 6.1 6.0 Direct 0.8 0.7 0.85 Indirect 5.0 5.4 5.15 The values of serum bilirubin total (mean) and indirect (mean) on the 8 day of life was lower in the Liv.52-treated group as compared to the phenobarbitone and control group as seen in Table 8. Table 8: Depicting the serum bilirubin levels on the 8 day of life in different groups Serum bilirubin (Mean) Liv.52 gGroup (mg%) Phenobarbitone (mg%) Control (mg%) Total 2.1 3.0 3.3 Direct 0.6 0.4 0.5 Indirect 1.5 2.6 2.8 DISCUSSION The present study showed that 81.25% of the first born, 52.85% of the second born and 25% of the third born neonates developed icterus. Of them, 71.43% were preterm and 46.85% were full term infants. Tovey et al. (1959), Barton et al. (1962) also reported the same pattern. This significant effect of gestational maturity on the incidence of jaundice can be explained by the immaturity of the liver. It was also observed that majority of the neonates (90.6%) who ultimately developed icterus, developed it by the 3 day of life. Workers have tried to prevent development of jaundice during the neonatal period., but none of their methods have proved satisfactory. Brown (1968) suggested avoidance of factors like anoxia, drugs, etc., which aggravate hyperbilirubinaemia. Cremer et al. (1958) and Baineha (1971) noted that serum bilirubin came down on exposure to sunlight or phototherapy. Cunningham (1969) observed that serum bilirubin did not regress if phenobarbitone was given after the appearance of icterus. In the present study, it was observed that 49.3% of the neonates who were getting Liv.52, and 60% of the neonates who were getting phenobarbitone-developed icterus whereas only 48% of neonates who were not getting either of the two drugs (control group) developed icterus. The total mean serum bilirubin percentage value on the 4 day among the icteric neonates was 5.8 mg% in the Liv.52 group, 6.1 mg% in the phenobarbitone group and 6.0 mg% in the control group (Table 7). The mean percentage of conjugated serum bilirubin (Direct) was 0.8 mg% (13.79% of the total) in the Liv.52 group; 0.7 mg% (11.47% of the total) in the phenobarbitone group and 0.85 mg% (14.16% of the total) in the control group. The mean day of disappearance of icterus was observed to be 7.5 days in the Liv.52 group, 7.564 days in the phenobarbitone group and 7.69 days in the control group. However, on the 8 day, the mean values of the total and indirect serum bilirubin were the lowest inthe neonates receiving Liv.52. This showed that in neonates on Liv.52 therapy, the severity oficterus was remarkably checked. It can be concluded that Liv.52 can effectively prevent theprogression of physiological jaundice in neonates. Liv.52 might also offer protection from the graveeffects of physiological icterus. Liv.52 was also safe and free of side effects. REFERENCES1. Billing, B.H., Cole, P.G., Lathe, G.H.: Increased plasma bilirubin in relation to birth weight.Brit. Med. J. (1954): 2, 1263.2. Blondhfien, S.H., Lathrop, D., Zabriskie, J.: A diffusible bilirubin (old) produced by exposureof jaundiced serum to light (Abst.). Gastroenterology (1960) : 38, 778. 3. Chafepar, V.D.: A clinical study on physiological jaundice in neonates. Probe (1968), 3, 85.4. Claireause, A.E. : Neonatal hyperbilirubinaemia. Brit. Med. J. (1960), 1, 1528.5. Mepay, R.J., Jr., Smith, C.A. Text Book of Pediatrics, by Nelson, W.F. (1964) : 380. 6. Mollison, P.L. : Physiological jaundice of the newborn. Lancet (1948) : 1, 513. 7. 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