Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Daily milk production (ml/24h) at end of Intervention period
研究概览
简要总结
After preterm birth mothers often suffer from hypogalactia. Herbal galactogogues can be used in order to increase milk production. In this double-blind, randomized, placebo-controlled clinical trial the effect of Silitidil, an extract from milk thistle, on the postpartal milk production in mothers of very premature newborns is investigated.
详细描述
Mothers of preterm infants born at a gestational age <= 32 wg are asked to participate in this double-blind, randomized, placebo-controlled interventional trial, where they will receive a preparation of the herbal galactogogue Silitidil or placebo over an intervention period of 3 weeks. The influence of the galactagogue will be investigated by monitoring daily milk production before, during and 1 week after cessation of the intervention. As secondary outcome parameters weight gain, the progress of enteral feeding, and the percentage of human milk feeding on total enteral feeding volumes will be monitored in the newborn infants. Also the breast milk composition (in terms of fatty acids, protein and carbohydrates content) will be investigated and compared between study groups. Saliva and urine probes will be collected at specific time points to survey hormonal reactions during the various phases of lactation and the relation of maternal hormone levels on milk production.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •mothers after preterm birth <= 32 weeks of gestation
- •Age of the newborn 1 - 5 days
- •Human milk feeding intended
排除标准
- •Ingestion of other galactagogues
- •maternal chronical disease requiring therapy (e.g. severe hypothyreosis, preexistent arterial hypertension, Type I or 2 Diabetes, chronic inflammatory bowel disease, severe bronchial asthma, pollinosis)
- •medication influencing prolactine levels
- •Mastitis at time of enrollment
- •mammary tumors or surgery influencing milk production
结局指标
主要结局
Daily milk production (ml/24h) at end of Intervention period
时间窗: 3 weeks after study initiation
Daily milk production (ml/24h) according to pumping protocol
次要结局
- Milk Protein Content during intervention(at 1 week after study initiation)
- Percentual increase in daily milk production(from 0 to 4 weeks after study initiation)
- Milk Protein Content at end of intervention(at 3 weeks after study initiation)
- Milk Protein Content after intervention(at 4 weeks after study initiation)
- Time point when enteral feeding volumes reach 120 ml/kgbw(4 weeks)
- Percentage of human milk feeding(4 weeks)
- daily milk production (ml/24h), baseline(at 0, 1 and 2 weeks after study initiation)
- daily milk production (ml/24h), follow-up(4 weeks after study initiation)
- Milk lactose Content during intervention(at 1 week after study initiation)
- Milk lactose Content at end of intervention(at 3 weeks after study initiation)
- Milk lactose Content after intervention(at 4 weeks after study initiation)
- Milk fatty acids Content during intervention(at 1week after study initiation)
- Milk fatty acids Content at end of intervention(at 3 weeks after study initiation)
- Milk fatty acids Content after intervention(at 4 weeks after study initiation)
- Incidence of formula feeding(4 weeks)
研究者
Dr. Hanna Petersen
Head of Institute for Pediatric Nutritional Research at the Waldkrankenhaus Protestant Hospital
Waldkrankenhaus Protestant Hospital, Spandau