Efficacy of Herbal Galactagogue Silitidil After Preterm Birth

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-14

Study Completion Date

2022-02-10

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Milk Production Human Milk Feeding Hypogalactia Preterm Infant Nutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Verum

Silitidil for 21 days

Group Type EXPERIMENTAL

Silitidil for 21 days

Intervention Type DIETARY_SUPPLEMENT

daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks

Placebo

Placebo for 21 days

Group Type PLACEBO_COMPARATOR

Placebo for 21 days

Intervention Type DIETARY_SUPPLEMENT

daily ingestion of Placebo preparation over time period of 3 weeks

Reference group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Silitidil for 21 days

daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo for 21 days

daily ingestion of Placebo preparation over time period of 3 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Silitidil Placebo

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes