Abstract
Introduction: Neonatal hyperbilirubinemia is a common physiologic condition, which is occurred in early days after birth with an estimated incidence of about 50% in term neonates. Objectives: The aim of this study was to evaluate the effect of Cotoneaster nummularioides manna on reducing neonatal total serum bilirubin (TSB) levels, and shortening hospitalization period. Patients and Methods: One hundred breast-fed term neonates with hyperbilirubinemia were randomly assigned to the intervention group or control group. The Newborns of the intervention group were received Cotoneaster manna drop in the dosage of 1 g/d divided into three doses every 8 hours for at least 3 days and the control group received placebo drops. Total serum bilirubin levels were measured at baseline, at 12, 24 hours and then daily through hospitalization days (day 9). Secondary outcome (discharge from hospital, TSB <10 mg/dL) was also documented with risk ratio calculation. Results: TSB levels were declined in both groups; however, this was more prominent in the manna group than the placebo group. The greatest difference of mean TSB levels between the intervention and control groups was seen on days two (10.01 versus 13.04 mg/dL; mean difference [95% CI]: - 3.03 [-3.60 to -2.46]; P<0.001). On day four, significantly more newborns in the intervention group versus the control group were discharged (70% versus 6.1%; risk ratio = 11.43, 95% CI= 3.76, 34.74). No major side effects were recorded in both groups. Conclusion:Cotoneaster nummularioides manna drop combined with phototherapy was superior to the control group in reducing TSB levels and reaching this observation more rapidly and shortening hospitalization period with no major side effects. Trial Registration: The trial protocol was approved by the Iranian Registry of Clinical trials (identifier: IRCT20160531028188N4; https://en.irct.ir/trial/27765, ethical code #IR.MAZUMS.REC.1394.1316).
Highlights
Neonatal hyperbilirubinemia is a common physiologic condition, which is occurred in early days after birth with an estimated incidence of about 50% in term neonates [1,2]
Even after adjustment for baseline total serum bilirubin (TSB) levels, the difference in TSB on day 1 rose to more than 2 mg/dL and within the 95% confidence interval (CI), the difference is higher than the minimal clinically important difference (MCID)
In a previous RCT to determine the efficacy of Cotoneaster manna (3 drops/ kg), in addition to phototherapy in reducing TSB levels in neonates with jaundice [14], the neonates, but their mothers received the Cotoneaster manna
Summary
Neonatal hyperbilirubinemia is a common physiologic condition, which is occurred in early days after birth with an estimated incidence of about 50% in term neonates. Objectives: The aim of this study was to evaluate the effect of Cotoneaster nummularioides manna on reducing neonatal total serum bilirubin (TSB) levels, and shortening hospitalization period. Conclusion: Cotoneaster nummularioides manna drop combined with phototherapy was superior to the control group in reducing TSB levels and reaching this observation more rapidly and shortening hospitalization period with no major side effects. The elevated serum bilirubin is usually benign in most neonates and is termed physiologic jaundice that responds well to phototherapy. Pathological jaundice, in particular, severe hyperbilirubinemia (generally defined as total serum bilirubin [TSB] level bilirubin >25 mg/dL) is less common (8-9%) [3], which may result in accumulation of unconjugated bilirubin in the infant’s tissues such as brain tissue and cause bilirubin-induced neurologic dysfunction and kernicterus [1,4]. A recent review of 13 randomized clinical trials [5] showed that supplementation with probiotics is a safe and effective intervention to manage
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