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Objective <p>To evaluate the efficacy and safety of melatonin supplementation as an adjunct to phototherapy in reducing serum bilirubin levels in preterm infants with neonatal jaundice.</p> Methods <p>This randomized, double-blind clinical trial enrolled 60 preterm infants (gestational age 35–37 weeks) with unconjugated neonatal jaundice. Participants were randomly assigned to two groups of 30 each: the control group received standard (phototherapy + placebo), and the intervention group received (phototherapy + oral melatonin) at a dose of 0.5&#xa0;mg/kg once daily for 48&#xa0;h. Serum bilirubin levels were measured at baseline, 24&#xa0;h, and 48&#xa0;h after treatment initiation.</p> Results <p>The mean serum bilirubin level in the melatonin group decreased from 17.12 ± 4.73&#xa0;mg/dL at baseline to 4.49 ± 2.95&#xa0;mg/dL at 48&#xa0;h, whereas in the control group (phototherapy + placebo), it decreased from 17.29 ± 3.52&#xa0;mg/dL to 6.72 ± 3.26&#xa0;mg/dL (<i>P</i> &lt; 0.05). The decline in bilirubin levels was significantly more rapid in the melatonin group starting at 24&#xa0;h. No adverse events including apnea, bradycardia, desaturation, poor feeding, vomiting, or delayed discharge were reported in either group, with a 0% attrition rate.</p> Conclusions <p>Melatonin (0.5&#xa0;mg/kg/day for 48&#xa0;h) as an adjunct to phototherapy is safe and accelerates bilirubin reduction in preterm infants with neonatal jaundice compared to phototherapy plus placebo. Larger studies with long-term follow-up are needed to confirm these findings.</p>

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Effect of melatonin supplementation as an adjunctive therapy for neonatal jaundice in preterm infants

  • 期刊论文

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  • 发表日期：

    2026年7月8日

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  • Reza Saeidi,
  • Farzaneh Ahmadi Khatiri,
  • Mohammad Kordkatouli

摘要

Objective

To evaluate the efficacy and safety of melatonin supplementation as an adjunct to phototherapy in reducing serum bilirubin levels in preterm infants with neonatal jaundice.

Methods

This randomized, double-blind clinical trial enrolled 60 preterm infants (gestational age 35–37 weeks) with unconjugated neonatal jaundice. Participants were randomly assigned to two groups of 30 each: the control group received standard (phototherapy + placebo), and the intervention group received (phototherapy + oral melatonin) at a dose of 0.5 mg/kg once daily for 48 h. Serum bilirubin levels were measured at baseline, 24 h, and 48 h after treatment initiation.

Results

The mean serum bilirubin level in the melatonin group decreased from 17.12 ± 4.73 mg/dL at baseline to 4.49 ± 2.95 mg/dL at 48 h, whereas in the control group (phototherapy + placebo), it decreased from 17.29 ± 3.52 mg/dL to 6.72 ± 3.26 mg/dL (P < 0.05). The decline in bilirubin levels was significantly more rapid in the melatonin group starting at 24 h. No adverse events including apnea, bradycardia, desaturation, poor feeding, vomiting, or delayed discharge were reported in either group, with a 0% attrition rate.

Conclusions

Melatonin (0.5 mg/kg/day for 48 h) as an adjunct to phototherapy is safe and accelerates bilirubin reduction in preterm infants with neonatal jaundice compared to phototherapy plus placebo. Larger studies with long-term follow-up are needed to confirm these findings.