Effects of Probiotics on Neonatal Hyperbilirubinemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Effect of Probiotic Support on Serum Bilirubin Levels
研究概览
简要总结
This study was designed as a prospective controlled study to investigate the effects of probiotic support started immediately after birth on newborn jaundice in breastfed babies born by normal spontaneous vaginal delivery.
详细描述
Objectives: Enterohepatic circulation of bilirubin imposes an extra burden of approximately 30% on total serum bilirubin levels. Intestinal microflora is the main factor affecting enterohepatic circulation. This study investigated the effects of probiotic support started immediately after birth on neonatal hyperbilirubinemia in babies born by normal spontaneous vaginal delivery and breastfed only.
Methods: A total of 150 healthy term newborns were included in the study and allocated in the study and control groups. Immediately after birth, newborns in the study group received probiotic in liquid drop form (Maflor® drops containing Lactobacillus Rhamnosus GG 109 Colony Forming Units(CFU), Mamsel Pharmaceuticals, Turkey), at a dose of 5 drops a day orally for 10 days. Newborns in the control group received 5 drops of saline solution per day orally, instead. In addition to routine biochemical examinations;serum bilirubin levels in the cord blood, and blood samples of the newborns on the 3rd, 5th and 10th days of birth were measured in all subjects in both groups. Defecation frequency was recorded for all subjects.
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
- 1 Day 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A total of 150 full-term (gestational age ≥37 - <42 weeks) normal spontaneous vaginal delivery healthy newborns
- •Birth weight between the 10th-90th percentiles
- •Fed by breast milk only
排除标准
- •Newborns with familial hematologic disorders
- •Having signs of hemolysis due to blood group incompatibilities
- •Bleeding into closed spaces due to birth trauma complications (e.g. cephalohematoma)
- •Suspected or documented neonatal infection such as chorioamnionitis, intrauterine infection, sepsis and urinary tract infection
- •Perinatal and neonatal hypoxia
- •Having thyroid dysfunction, respiratory distress or insufficiency, metabolic and thermoregulatory dysfunction, hemodynamic instability and congenital heart disease
- •Maternal phenobarbital usage history during the last month of the pregnancy
- •Having venous hematocrit (Htc) levels≥65%
结局指标
主要结局
Effect of Probiotic Support on Serum Bilirubin Levels
时间窗: Change from birth to ten days of life
The effect of probiotic support on serum bilirubin levels during the first 10 days were measured and results were given as mg/dL.
次要结局
- Defecation frequency(Change from birth to ten days of life)
研究者
Mehmet Mutlu, MD
Assoc. Prof.
Karadeniz Technical University