Breast Milk Production, Human Milk Feeding, Hypogalactia, Preterm Infant Nutrition
Conditions
Keywords
galactagogue, milk thistle, silymarin, Silitidil
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.
Interventions
DIETARY_SUPPLEMENTSilitidil for 21 days
daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
DIETARY_SUPPLEMENTPlacebo for 21 days
daily ingestion of Placebo preparation over time period of 3 weeks
Sponsors
DMK Group
Waldkrankenhaus Protestant Hospital, Spandau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily milk production (ml/24h) at end of Intervention period | 3 weeks after study initiation | Daily milk production (ml/24h) according to pumping protocol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Milk lactose Content at end of intervention | at 3 weeks after study initiation | Lactose content in breast milk sample (mg/100ml) |
| Incidence of formula feeding | 4 weeks | Incidence of (additional) formula feeding at 4 weeks of life |
| Time point when enteral feeding volumes reach 120 ml/kgbw | 4 weeks | day of life when enteral feeding volumes of the preterm Infant have reached 120 ml per kg bodyweight |
| Percentage of human milk feeding | 4 weeks | Percentage of human milk feeding on total feeding volume of the preterm infant |
| daily milk production (ml/24h), baseline | at 0, 1 and 2 weeks after study initiation | Daily milk production (ml/24h) according to pumping protocol |
| daily milk production (ml/24h), follow-up | 4 weeks after study initiation | Daily milk production (ml/24h) according to pumping protocol |
| Percentual increase in daily milk production | from 0 to 3 weeks after study initiation | Percentual increase in daily milk production comparing daily milk production (ml/24h) before and at end of intervention |
| Milk Protein Content during intervention | at 1 week after study initiation | Protein content in breast milk sample (mg/100ml) |
| Milk Protein Content at end of intervention | at 3 weeks after study initiation | Protein content in breast milk sample (mg/100ml) |
| Milk Protein Content after intervention | at 4 weeks after study initiation | Protein content in breast milk sample (mg/100ml) |
| Milk lactose Content during intervention | at 1 week after study initiation | Lactose content in breast milk sample (mg/100ml) |
| Milk lactose Content after intervention | at 4 weeks after study initiation | Lactose content in breast milk sample (mg/100ml) |
| Milk fatty acids Content during intervention | at 1week after study initiation | Fatty acids content in breast milk sample (mg/100ml) |
| Milk fatty acids Content at end of intervention | at 3 weeks after study initiation | Fatty acids content in breast milk sample (mg/100ml) |
| Milk fatty acids Content after intervention | at 4 weeks after study initiation | Fatty acids content in breast milk sample (mg/100ml) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal Urine prolactin/creatinin-ratio | 4 weeks | Maternal urine prolactin and creatinin levels before and after breast pumping are determined to create prolactin/creatin-ratio |
| Maternal alpha-Amylase level in saliva | 4 weeks | Maternal alpha-amylase levels before and after breast pumping are determined in saliva samples |
| Maternal cortisol level in saliva | 4 weeks | Maternal cortisol levels before and after breast pumping are determined in saliva samples |
| Maternal urine oxytocin/creatinin-ratio | 4 weeks | Maternal urine oxytocin and creatinin levels before and after breast pumping are determined to create oxytocin/creatin-ratio |
| Incidence of mastitis | 4 weeks | Incidence of clinical mastitis during intervention period |
Countries
Germany
Outcome results
None listed