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

NCT06191523 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-01-05

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universitas Sebelas Maret

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-27
Primary Completion
2023-10-05
Completion
2023-10-20

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06191523 on ClinicalTrials.gov