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

• Status: Completed
• Trial end date: 2023-10-20
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitas Sebelas Maret

Criteria

Inclusion Criteria:

• Newborns with gestational age of 28-36+6 weeks, birth weight according to gestational age, and diagnosis of sepsis based on HPS and PRS sepsis score criteria

Exclusion Criteria:

• Major congenital anomalies of the gastrointestinal tract.

• Continuous vomiting.

• Newborns with hypoxic ischemic encephalopathy (HIE), intracranial hemorrhage, feeding intolerance, necrotizing enterocolitis (NEC) and hormonal disorders.

• Septic shock.