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 range28 Weeks – 36 Weeks

SexALL

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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.

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