Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 8
- 主要终点
- Level of serum prolactin
研究概览
简要总结
Femaltiker is a food for special medical purposes with a unique composition. Because beer, but not ethanol, has been reported in a number of studies to stimulate prolactin levels and breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. To verify our assumption, a randomized, double blinded research with placebo was performed. The study was conducted according to good clinical practice and 10% of output data was audited by the outside monitor. The research was conducted from 14 April 2014 to 7 October 2015 in two NICUs with consent of the ethics committee on Medical Warsaw University.
详细描述
The traget population consisted of volunteers women who delivered infants at < 37 weeks gestation. Criteria of exclusion were: hypothyroidism and diabetes type I or II diagnosed and treated before pregnancy.
The schedule of the study included three visits with in certain point time during two weeks postpartum. During the study patients had taken twice a day product or placebo, respectively. The protocol of the study included :
- Three consecutive blood collections for examination of prolactin level on every visit (10 min beforeBlood examination of prolactin level in triplet on every visit (10 min before breastfeeding session, 10 min after beginning of breastfeeding and 10 min. after finishing of breastfeeding.)
- Filling pumping log to control variation in the milk yield and efficacy of lactation.
- Measurement of the volume of milk producing before blood examination (directly in case of pumping by the mother or indirectly based on weight of the baby before and after feeding)
- Interview with lactation consultant concerning patient's self-estimation of lactation efficacy Data collection was done using the CRF in the paper form which were then put tto the database in ExcelDocuments.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
To mask intervention the placebo was used. In this case, the placebo was prepared as a blend of sucrose, apple fiber and natural aroma caramel by subcontractor of the producer, accordingly to the GMP (number of sachets prepared 1534). Placebo sachets were in the same size sachets as the product and could be hardly distinguished in term of color, taste or texture and flavor. To the end of the trial patients and medical staff were blinded which sachet contained active product. People responsible for the data clean-up and statistics were partially blinded since theyhad to know which patients were in the same treatment group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •mothers of preterm infants (born before 37 completed weeks of pregnancy)
排除标准
- •hypothyroidism
- •diabetes type I or II diagnosed and treated before pregnancy
- •participating in other study
研究组 & 干预措施
Femaltiker
7.7 g of Femaltiker twice a day for 14 days of the trial.
干预措施: Femaltiker (Other)
placebo
7.7 g placebo 14 days of the trial.
干预措施: Placebo (Other)
结局指标
主要结局
Level of serum prolactin
时间窗: two weeks after delivery
Three consecutive blood collections for prolactin level
The volume of milk produced by study participants
时间窗: two weeks after delivery
Measurement of the volume of expressed milk
次要结局
未报告次要终点
研究者
Maria Katarzyna Kornacka
Professor of Neonatology
Medical University of Warsaw