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

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.

Study Overview

• Status: Completed
• Conditions: Lactation Induced
• Intervention / Treatment: Other: Femaltiker; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 00315
    • Warsaw Medical University Hospital
  • Warsaw, Poland, 02015
    • Mother and Child Health Center of Warsaw Medical University
  • Warsaw, Poland, 02091
    • Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital
  • Warsaw, Poland, 02091
    • Warsaw Medical University - Clinic of Neonatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Femaltiker; 7.7 g of Femaltiker twice a day for 14 days of the trial.	Other: Femaltiker; Patient had taken twice a day the product; Other Names: LACTANELL formula
Placebo Comparator: placebo; 7.7 g placebo 14 days of the trial.	Other: Placebo; Patient had taken twice a day the placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Human Milk Bank Foundation; Nutropharma LLC
• Investigators: Study Director: Aleksandra Wesolowska, PhD, Warsaw Medical University, Department of Neonatology; Principal Investigator: Maria K. Borszewska-Kornacka, Prof., Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): October 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: November 11, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): June 28, 2019
• Last Update Submitted That Met QC Criteria: June 27, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: galactagogues, lactogenesis, preterm labor
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: FEMA/01/2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No