Prenatal Administration of Oral Spermine Promotes Maturation of Premature Fetal Gut Epithelial Tight Junction: Experimental Study on Oryctolagus Cuniculus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Occludin
研究概览
简要总结
Infections, particularly on the gastrointestinal tract, has been known to be one of the leading causes of death in preterm infants. This is due to the immaturity of the intestinal epithelial cells. Recent studies have shown that polyamines have a role on the development of cells during embryonal phase. By this experimental study, the investigators would like to evaluate the administration of spermine on the maturation of premature fetal gut epithelial tight junction.
详细描述
This experimental study is conducted with minimum 24 subjects which divided into 6 groups; 1) 24-days pregnant and is given prenatal spermine, 2) 26-days pregnant and is given prenatal spermine, 3) 28-days pregnant and is given prenatal spermine, 4) 24-days pregnant and is not given prenatal spermine, 5) 26-days pregnant and is not given prenatal spermine, and 6) 28-days pregnant and is not given prenatal spermine. At the end of desired pregnancy period, hysterectomy is done and fetus are born. From each parent subject, three fetal samples are chosen using a random sampling. Intestinal tissues are taken from each fetal sample to be examined. Several data will be collected i.e. occludin, β-catenin, and β-actin, as well as histological morphologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 24 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intestinal tissue of fetal rabbit that is prematurely alive
排除标准
- •Intestinal tissue of fetal rabbit that is dead before termination
- •Intestinal tissue of fetal rabbit, in which the parent died before termination
研究组 & 干预措施
24-Day Non Spermine Group
Subjects are not given any intervention. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.
26-Day Non Spermine Group
Subjects are not given any intervention. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.
28-Day Non Spermine Group
Subjects are not given any intervention. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.
28-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 28 days of pregnancy. On day 28 pregnancy is terminated and intestinal tissue sample is taken to be examined.
干预措施: Spermine (Biological)
26-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 26 days of pregnancy. On day 26 pregnancy is terminated and intestinal tissue sample is taken to be examined.
干预措施: Spermine (Biological)
24-Day Spermine Group
Subjects are given prenatal spermine (20 mg per body weight) during 24 days of pregnancy. On day 24 pregnancy is terminated and intestinal tissue sample is taken to be examined.
干预措施: Spermine (Biological)
结局指标
主要结局
Occludin
时间窗: 2 weeks
Measurement of occludin (ng/mg protein) from intestinal tissue sample is assessed using Rabbit Occludin ELISA Kit
β-catenin
时间窗: 2 weeks
Measurement of β-catenin (pg/mg protein) from intestinal tissue sample is assessed using Rabbit β-Catenin ELISA Kit
β-actin
时间窗: 2 weeks
Measurement of β-actin (ng/mg protein) from intestinal tissue sample is assessed using β-Actin ELISA Kit
次要结局
- Histologic Findings(2 weeks)
研究者
dr. Riana Pauline Tamba, SpB(K)BA
Consultant Pediatric Surgeon
Indonesia University