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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
106
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
daily ingestion of Placebo preparation over time period of 3 weeks
Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie
Berlin-Spandau, Germany
Daily milk production (ml/24h) at end of Intervention period
Daily milk production (ml/24h) according to pumping protocol
Time frame: 3 weeks after study initiation
Percentual increase in daily milk production
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention
Time frame: from 0 to 3 weeks after study initiation
Percentual increase in daily milk production
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention
Time frame: from 0 to 4 weeks after study initiation
Milk Protein Content during intervention
Protein content in breast milk sample (mg/100ml)
Time frame: at 1 week after study initiation
Milk Protein Content at end of intervention
Protein content in breast milk sample (mg/100ml)
Time frame: at 3 weeks after study initiation
Milk Protein Content after intervention
Protein content in breast milk sample (mg/100ml)
Time frame: at 4 weeks after study initiation
Milk lactose Content during intervention
Lactose content in breast milk sample (mg/100ml)
Time frame: at 1 week after study initiation
Milk lactose Content at end of intervention
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Lactose content in breast milk sample (mg/100ml)
Time frame: at 3 weeks after study initiation
Milk lactose Content after intervention
Lactose content in breast milk sample (mg/100ml)
Time frame: at 4 weeks after study initiation
Milk fatty acids Content during intervention
Fatty acids content in breast milk sample (mg/100ml)
Time frame: at 1week after study initiation
Milk fatty acids Content at end of intervention
Fatty acids content in breast milk sample (mg/100ml)
Time frame: at 3 weeks after study initiation
Milk fatty acids Content after intervention
Fatty acids content in breast milk sample (mg/100ml)
Time frame: at 4 weeks after study initiation
Incidence of formula feeding
Incidence of (additional) formula feeding at 4 weeks of life
Time frame: 4 weeks
Time point when enteral feeding volumes reach 120 ml/kgbw
day of life when enteral feeding volumes of the preterm Infant have reached 120 ml per kg bodyweight
Time frame: 4 weeks
Percentage of human milk feeding
Percentage of human milk feeding on total feeding volume of the preterm infant
Time frame: 4 weeks
daily milk production (ml/24h), baseline
Daily milk production (ml/24h) according to pumping protocol
Time frame: at 0, 1 and 2 weeks after study initiation
daily milk production (ml/24h), follow-up
Daily milk production (ml/24h) according to pumping protocol
Time frame: 4 weeks after study initiation