CompletedNot Applicable

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

Indonesia42 participantsStarted 2023-04-27

Plain-language 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

Who can participate

Age range

28 Weeks – 36 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: From enrollment to the end of treatment at 6 months

Trial details

NCT IDNCT06191523

SponsorUniversitas Sebelas Maret

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-05

View on ClinicalTrials.gov More Sepsis Newborn trials