Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

Forest Hospital Protestant Hospital

Status: Completed

Conditions: Breast Milk Production; Preterm Infant Nutrition; Hypogalactia; Human Milk Feeding

Treatments: Dietary Supplement: Placebo for 21 days; Dietary Supplement: Silitidil for 21 days

Study type: Interventional

Funder types: Other

Identifiers

NCT03577587

EWK-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 106 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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106 participants in 3 patient groups, including a placebo group

Verum

Experimental group

Description:

Silitidil for 21 days

Treatment:

Dietary Supplement: Silitidil for 21 days

Placebo

Placebo Comparator group

Description:

Placebo for 21 days

Treatment:

Dietary Supplement: Placebo for 21 days

Reference group

No Intervention group

Description:

Non-randomized healthy volunteering mothers after term birth receiving no intervention