Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants (FEMA)

Medical University of Warsaw

Status: Completed

Conditions: Lactation Induced

Treatments: Other: Placebo; Other: Femaltiker

Study type: Interventional

Funder types: Other

Identifiers

NCT03341481

FEMA/01/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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109 participants in 2 patient groups, including a placebo group

Femaltiker

Experimental group

Description:

7.7 g of Femaltiker twice a day for 14 days of the trial.

Treatment:

Other: Femaltiker

placebo

Placebo Comparator group

Description:

7.7 g placebo 14 days of the trial.

Treatment:

Other: Placebo