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

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06191523

Enrollment

Registered

2024-01-05

Start date

2023-04-27

Completion date

2023-10-20

Last updated

2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis Newborn

Keywords

melatonin, sepsis, preterm neonates

Brief 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

Interventions

OTHERControl Group

The control group will receive standard therapy and placebo.

DRUGTreatment Group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 36 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System	From enrollment to the end of treatment at 6 months

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026