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| Name | Class |
|---|---|
| DMK Group | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verum | Experimental | Silitidil for 21 days |
|
| Placebo | Placebo Comparator | Placebo for 21 days |
|
| Reference group | No Intervention | Non-randomized healthy volunteering mothers after term birth receiving no intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Silitidil for 21 days | Dietary Supplement | daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily milk production (ml/24h) at end of Intervention period | Daily milk production (ml/24h) according to pumping protocol | 3 weeks after study initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Percentual increase in daily milk production | Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention | from 0 to 3 weeks after study initiation |
| Percentual increase in daily milk production |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal urine oxytocin/creatinin-ratio | Maternal urine oxytocin and creatinin levels before and after breast pumping are determined to create oxytocin/creatin-ratio | 4 weeks |
| Maternal Urine prolactin/creatinin-ratio |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Jochum, MD | Head of Paediatric Department | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelic Waldkrankenhaus Spandau, Paul Gerhardt Diakonie | Berlin-Spandau | 13589 | Germany |
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| ID | Term |
|---|---|
| D007775 | Lactation Disorders |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Placebo for 21 days | Dietary Supplement | daily ingestion of Placebo preparation over time period of 3 weeks |
|
|
Percentual increase in daily milk production comparing daily milk production (ml/24h) before and 1 week after intervention |
| from 0 to 4 weeks after study initiation |
| Milk Protein Content during intervention | Protein content in breast milk sample (mg/100ml) | at 1 week after study initiation |
| Milk Protein Content at end of intervention | Protein content in breast milk sample (mg/100ml) | at 3 weeks after study initiation |
| Milk Protein Content after intervention | Protein content in breast milk sample (mg/100ml) | at 4 weeks after study initiation |
| Milk lactose Content during intervention | Lactose content in breast milk sample (mg/100ml) | at 1 week after study initiation |
| Milk lactose Content at end of intervention | Lactose content in breast milk sample (mg/100ml) | at 3 weeks after study initiation |
| Milk lactose Content after intervention | Lactose content in breast milk sample (mg/100ml) | at 4 weeks after study initiation |
| Milk fatty acids Content during intervention | Fatty acids content in breast milk sample (mg/100ml) | at 1week after study initiation |
| Milk fatty acids Content at end of intervention | Fatty acids content in breast milk sample (mg/100ml) | at 3 weeks after study initiation |
| Milk fatty acids Content after intervention | Fatty acids content in breast milk sample (mg/100ml) | at 4 weeks after study initiation |
| Incidence of formula feeding | Incidence of (additional) formula feeding at 4 weeks of life | 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 | 4 weeks |
| Percentage of human milk feeding | Percentage of human milk feeding on total feeding volume of the preterm infant | 4 weeks |
| daily milk production (ml/24h), baseline | Daily milk production (ml/24h) according to pumping protocol | 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 | 4 weeks after study initiation |
Maternal urine prolactin and creatinin levels before and after breast pumping are determined to create prolactin/creatin-ratio
| 4 weeks |
| Maternal alpha-Amylase level in saliva | Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples | 4 weeks |
| Maternal cortisol level in saliva | Maternal cortisol levels before and after breast pumping are determined in saliva samples | 4 weeks |
| Incidence of mastitis | Incidence of clinical mastitis during intervention period | 4 weeks |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |