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临床试验/NCT07394322
NCT07394322已完成不适用

The Role of Serum of Interleukin-6 in Predicting the Development of Meconium Aspiration Syndrome in Infants Born With Meconium-Stained Amniotic Fluid

Benha University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
serum IL-6

研究概览

简要总结

This trial is intended to assess the serum levels of interleukin-6 as a predictive factor for the occurrence of meconium aspiration syndrome in infants born with MSAF.

详细描述

Meconium aspiration syndrome happens when a baby inhales a combination of meconium (the first stool) as well as amniotic fluid into their lungs during the delivery process. Meconium aspiration syndrome is a prevalent reason for significant respiratory failure in full-term or post-term newborns. MAS fluid is responsible for around 8 to 19% of all term deliveries, and meconium aspiration syndrome develops in around five to thirty-three percent of these infants (1).

Interleukin-6 is classified as a cytokine. One of the mediators of inflammation released early in septic shock is critical for initiating the immune response. It also has a role in activating T lymphocytes and B lymphocytes, as well as encouraging lymphocyte proliferation and differentiation. Furthermore, IL-6 possesses strong pyrogenic properties. Additionally, it stimulates the secretion of acute-phase proteins like CRP (2).

IL-6 is a powerful inflammatory agent, as well as its level in the blood has been assessed as a predictive marker in many studies. It is considered one of the foremost indications of prenatal inflammation. Raised levels of interleukin-6 are also observed in both infectious & non-infectious inflammatory and stressful conditions (2, 3).

Nonspecific symptoms such as a rise in breathing in flattening of the diaphragm, radiography & irregular linear or patchy patches of atelectasis are observed during the early phase of meconium aspiration syndrome. These signs are present in the early stages of syndrome. However, characteristic indications, for instance, extensive, coarse, and evenly distributed opacities resulting from pneumonia & interstitial edema, may not manifest until 2-3 days later. Therefore, it is necessary to use indicators to predict whether people are prone to developing MAS. The role of inflammation in the progression of MAS is acknowledged (4).

Prior studies have shown that cytokine levels in Meconium aspiration syndrome experience an elevation in both controlled laboratory conditions (in vitro) as well as living creatures (in vivo) (5).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
1 Minute 至 72 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • both genders (Males and females), term infants (above 37 gestational weeks), and born from ladies who have meconium-stained amniotic fluid.

排除标准

  • Infants born to mothers suspected of having chorioamnionitis (leukocytosis, fever, early membrane rupture (above 18 hours), foul-smelling discharge, tachycardia in the mother or fetus, as well as a positive blood culture),
  • those without parental consent,
  • those with severe perinatal asphyxia (Stage two or three of hypoxic-ischemic encephalopathy findings according to Sarnat (6)),
  • those with severe chorioamnionitis,
  • those withcongenital abdominal malformations,

研究组 & 干预措施

120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hos

Experimental

120 term newborns who were born from mothers who had MSAF & admitted to NICU at Benha University hospitals for a period of 1year, starting from February 2022 to February 2023 (Approval No: MS-15-1-2022). Patients were divided according to outcome into two groups: Group 1 (MAS group) contained 60 neonates who developed meconium aspiration syndrome, & Group 2 (control group) involved 60 neonates who did not develop meconium aspiration syndrome.

干预措施: serum interleukin 6 (Diagnostic Test)

结局指标

主要结局

serum IL-6

时间窗: in 3 days of delivery

Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA

: Evaluating the levels of interleukin-6 (IL-6) in the blood serum to determine its ability to predict the occurrence of MAS in newborns delivered with meconium-stained amniotic fluid.

时间窗: in 3 days of delivery

Serum IL-6: An enzyme-linked immunosorbent test (ELISA) that was developed to quantify the amount of the target bound amongst a matched pair of antibodies was the Human IL-6 solid-phase sandwich ELISA

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nashwa farouk Mohamed

lecturer of pediatrics

Benha University

研究点 (1)

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