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

Universitas Sebelas Maret

Status: Completed

Conditions: Sepsis Newborn

Treatments: Other: Control Group; Drug: Treatment Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06191523

1.657/XII/HREC/2022

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 28 to 36 weeks old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

The control group will receive standard therapy and placebo.

Treatment:

Other: Control Group

Drug: Treatment Group

Treatment Group

Experimental group

Description:

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

Treatment:

Other: Control Group

Drug: Treatment Group