Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns

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.

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.

Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention

Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention

Maternal urine oxytocin and creatinin levels before and after breast pumping are determined to create oxytocin/creatin-ratio

Maternal urine prolactin and creatinin levels before and after breast pumping are determined to create prolactin/creatin-ratio

Inclusion Criteria: mothers after preterm birth <= 32 weeks of gestation Age of the newborn 1 - 5 days Human milk feeding intended Exclusion Criteria: 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