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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-27

Study Completion Date

2023-10-20

Brief Summary

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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

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Detailed Description

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Conditions

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Sepsis Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

The control group will receive standard therapy and placebo.

Group Type PLACEBO_COMPARATOR

Control Group

Intervention Type OTHER

The control group will receive standard therapy and placebo.

Treatment Group

Intervention Type DRUG

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

Treatment Group

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

Group Type EXPERIMENTAL

Control Group

Intervention Type OTHER

The control group will receive standard therapy and placebo.

Treatment Group

Intervention Type DRUG

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

Interventions

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Control Group

The control group will receive standard therapy and placebo.

Intervention Type OTHER

Treatment Group

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

36 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No