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

Not Applicable

Completed

• Conditions: Sepsis Newborn
• Interventions: Other: Control Group; Drug: Treatment Group

• Registration Number: NCT06191523
• Lead Sponsor: Universitas Sebelas Maret

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-27
• Primary Completion: 2023-10-05
• Study Completion: 2023-10-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-19
• Study First Submitted QC: 2023-12-20
• Last Update Submitted: 2023-12-20
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System	From enrollment to the end of treatment at 6 months

Trial Locations

Locations (1)

Dwi Hidayah; 🇮🇩 Surakarta, Central Java, Indonesia