Clinical trial NCT03577587: Efficacy of Herbal Galactagogue Silitidil After Preterm Birth
Official title: Effect and Efficacy of the Herbal Galactagogue Silitidil From Milk Thistle in Mothers of Very Preterm Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Milk Production
Human Milk Feeding
Hypogalactia
Preterm Infant Nutrition
Keywords: galactagogue
milk thistle
silymarin
Silitidil
Lead sponsor: Waldkrankenhaus Protestant Hospital, Spandau
Sponsor class: OTHER
Collaborators: name: DMK Group
First posted: 2018-07-05
Enrollment: 106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily milk production (ml/24h) at end of Intervention period
timeFrame: 3 weeks after study initiation
Secondary outcomes:
measure: Percentual increase in daily milk production
timeFrame: from 0 to 3 weeks after study initiation
measure: Percentual increase in daily milk production
timeFrame: from 0 to 4 weeks after study initiation
measure: Milk Protein Content during intervention
timeFrame: at 1 week after study initiation
measure: Milk Protein Content at end of intervention
timeFrame: at 3 weeks after study initiation
measure: Milk Protein Content after intervention
timeFrame: at 4 weeks after study initiation
measure: Milk lactose Content during intervention
timeFrame: at 1 week after study initiation
measure: Milk lactose Content at end of intervention
timeFrame: at 3 weeks after study initiation
measure: Milk lactose Content after intervention
timeFrame: at 4 weeks after study initiation
measure: Milk fatty acids Content during intervention
timeFrame: at 1week after study initiation
measure: Milk fatty acids Content at end of intervention
timeFrame: at 3 weeks after study initiation
measure: Milk fatty acids Content after intervention
timeFrame: at 4 weeks after study initiation
measure: Incidence of formula feeding
timeFrame: 4 weeks
measure: Time point when enteral feeding volumes reach 120 ml/kgbw
timeFrame: 4 weeks
measure: Percentage of human milk feeding
timeFrame: 4 weeks
measure: daily milk production (ml/24h), baseline
timeFrame: at 0, 1 and 2 weeks after study initiation
measure: daily milk production (ml/24h), follow-up
timeFrame: 4 weeks after study initiation
Other outcomes:
measure: Maternal urine oxytocin/creatinin-ratio
timeFrame: 4 weeks
measure: Maternal Urine prolactin/creatinin-ratio
timeFrame: 4 weeks
measure: Maternal alpha-Amylase level in saliva
timeFrame: 4 weeks
measure: Maternal cortisol level in saliva
timeFrame: 4 weeks
measure: Incidence of mastitis
timeFrame: 4 weeks
Locations:
city: Berlin-Spandau
country: Germany
facility: Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie
Study officials:
affiliation: Head of Paediatric Department
name: Frank Jochum, MD
role: STUDY_DIRECTOR
References: