Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

  • STATUS
    Recruiting
  • days left to enroll
    23
  • participants needed
    92
  • sponsor
    Waldkrankenhaus Protestant Hospital, Spandau
Updated on 9 May 2021

Summary

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.

Description

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.

Details
Condition Hypogalactia, Breast Milk Production, Human Milk Feeding, Preterm Infant Nutrition
Treatment Silitidil for 21 days, Placebo for 21 days
Clinical Study IdentifierNCT03577587
SponsorWaldkrankenhaus Protestant Hospital, Spandau
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

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
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