Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

Not Applicable

Completed

• Conditions: Lactation Induced
• Interventions: Other: Femaltiker; Other: Placebo

• Registration Number: NCT03341481
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study Start: 2014-04
• Primary Completion: 2015-10
• Study Completion: 2015-11
• Study First Submitted: 2017-03-23
• Status Verified: 2017-11
• Study First Submitted QC: 2017-11-11
• Study First Posted: 2017-11-14
• Last Update Submitted: 2019-06-27
• Last Update Posted: 2019-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femaltiker	Femaltiker	7.7 g of Femaltiker twice a day for 14 days of the trial.
placebo	Placebo	7.7 g placebo 14 days of the trial.

Primary Outcome Measures

Name	Time	Method
Level of serum prolactin	two weeks after delivery	Three consecutive blood collections for prolactin level
The volume of milk produced by study participants	two weeks after delivery	Measurement of the volume of expressed milk

Trial Locations

Locations (4)

Warsaw Medical University - Clinic of Neonatology; 🇵🇱 Warsaw, Poland

Warsaw Medical University Hospital; 🇵🇱 Warsaw, Poland

Mother and Child Health Center of Warsaw Medical University; 🇵🇱 Warsaw, Poland

Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital; 🇵🇱 Warsaw, Poland