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

December 20, 2023 updated by: Dwi Hidayah, Universitas Sebelas Maret

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Java
      • Surakarta, Central Java, Indonesia, 57126
        • Dwi Hidayah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control Group
The control group will receive standard therapy and placebo.
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
Experimental: Treatment Group
The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of treatment at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Sebelas Maret

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2023

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.657/XII/HREC/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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