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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Newborn Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Infections Inflammation Neonatal Sepsis Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

28 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dwi Hidayah

Surakarta, Central Java, 57126, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Control Group

Other

The control group will receive standard therapy and placebo.

Treatment group

Drug

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

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

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Official study title

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)

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jan 5, 2024
Registry last updated: Jan 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed