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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control Group
The control group will receive standard therapy and placebo.
干预措施: Control Group (Other)
Control Group
The control group will receive standard therapy and placebo.
干预措施: Treatment Group (Drug)
Treatment Group
The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg
干预措施: Control Group (Other)
Treatment Group
The participants in the treatment group will receive standard therapy and a single dose of oral melatonin 20 mg
干预措施: Treatment Group (Drug)
结局指标
主要结局
Number of Participants with Treatment-Related Improvement of Sepsis Score Based on Gitto Scoring System
时间窗: From enrollment to the end of treatment at 6 months
次要结局
未报告次要终点
研究者
Dwi Hidayah
Doctoral Program
Universitas Sebelas Maret