NCT06191523

The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis

The Effect of Melatonin as an Adjuvant Therapy for Preterm Neonates With Sepsis (Review of Malondialdehyde, Interleukin-6, Interleukin-8, Absolute Neutrophil Counts, and Sepsis Score)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Universitas Sebelas Maret · Academic / Other
• Sex: All
• Age: 28 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the effect of melatonin on MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis. The main question aim to answer : • Does melatonin affect MDA serum, IL-6, IL-8 levels, ANC, and sepsis score in preterm neonates with sepsis? The participants in the treatment group will receive a single dose of oral melatonin 20 mg, meanwhile those the control group will receive placebo. The researchers will compare MDA serum, IL-6, IL-8 levels, ANC, and sepsis score before and after receiving melatonin, whether there are decreases of MDA serum, IL-6, IL-8 levels, ANC and increase of sepsis score

Conditions

• Sepsis Newborn

Interventions

Type	Name	Description
OTHER	Control Group	The control group will receive standard therapy and placebo.
DRUG	Treatment Group	The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

Timeline

• Start date: 2023-04-27
• Primary completion: 2023-10-05
• Completion: 2023-10-20
• First posted: 2024-01-05
• Last updated: 2024-01-05

Locations

1 site across 1 country: Indonesia