Lactation Induced
Conditions
Keywords
galactagogues, lactogenesis, preterm labor
Brief summary
Femaltiker is a food for special medical purposes with a unique composition. Because beer, but not ethanol, has been reported in a number of studies to stimulate prolactin levels and breastmilk production, polysaccharide from barley was chosen as a potential galactogogue. To verify our assumption, a randomized, double blinded research with placebo was performed. The study was conducted according to good clinical practice and 10% of output data was audited by the outside monitor. The research was conducted from 14 April 2014 to 7 October 2015 in two NICUs with consent of the ethics committee on Medical Warsaw University.
Detailed description
The traget population consisted of volunteers women who delivered infants at \< 37 weeks gestation. Criteria of exclusion were: hypothyroidism and diabetes type I or II diagnosed and treated before pregnancy. The schedule of the study included three visits with in certain point time during two weeks postpartum. During the study patients had taken twice a day product or placebo, respectively. The protocol of the study included : * Three consecutive blood collections for examination of prolactin level on every visit (10 min beforeBlood examination of prolactin level in triplet on every visit (10 min before breastfeeding session, 10 min after beginning of breastfeeding and 10 min. after finishing of breastfeeding.) * Filling pumping log to control variation in the milk yield and efficacy of lactation. * Measurement of the volume of milk producing before blood examination (directly in case of pumping by the mother or indirectly based on weight of the baby before and after feeding) * Interview with lactation consultant concerning patient's self-estimation of lactation efficacy Data collection was done using the CRF in the paper form which were then put tto the database in ExcelDocuments.
Interventions
OTHERFemaltiker
Patient had taken twice a day the product
OTHERPlacebo
Patient had taken twice a day the placebo
Sponsors
Human Milk Bank Foundation
Nutropharma LLC
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
To mask intervention the placebo was used. In this case, the placebo was prepared as a blend of sucrose, apple fiber and natural aroma caramel by subcontractor of the producer, accordingly to the GMP (number of sachets prepared 1534). Placebo sachets were in the same size sachets as the product and could be hardly distinguished in term of color, taste or texture and flavor. To the end of the trial patients and medical staff were blinded which sachet contained active product. People responsible for the data clean-up and statistics were partially blinded since theyhad to know which patients were in the same treatment group.
Intervention model description
Treatment was given to the mothers assigned to the galactogogue group, whereas a placebo was given to those assigned to the placebo group. Each patient randomized to either treatment or placebo group received 28 sachets for 14 days of the trial.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* mothers of preterm infants (born before 37 completed weeks of pregnancy)
Exclusion criteria
* hypothyroidism * diabetes type I or II diagnosed and treated before pregnancy * participating in other study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The volume of milk produced by study participants | two weeks after delivery | Measurement of the volume of expressed milk |
| Level of serum prolactin | two weeks after delivery | Three consecutive blood collections for prolactin level |
Countries
Poland
Outcome results
None listed