Lactation Induced Clinical Trial
Official title:
Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants
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.
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.
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