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

N/ACompletedNCT06191523

Universitas Sebelas Maret42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sepsis Newborn

Interventions

The control group will receive standard therapy and placebo.

Treatment GroupDRUG

The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 36 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Dwi Hidayah

Surakarta, Central Java, Indonesia

Outcomes

Primary Outcomes

Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System

Time frame: From enrollment to the end of treatment at 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.