FEMA: Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

Sponsor

Medical University of Warsaw (Other)

Overall Status

Completed

CT.gov ID

NCT03341481

Collaborator

Human Milk Bank Foundation (Other), Nutropharma LLC (Other)

109

Enrollment

Locations

Arms

Duration (Months)

27.3

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lactation Induced	Other: Femaltiker Other: Placebo	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

109 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Triple (Participant, Care Provider, 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.

Primary Purpose:

Treatment

Official Title:

Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants

Study Start Date :

Apr 1, 2014

Actual Primary Completion Date :

Oct 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Warsaw Medical University Hospital	Warsaw	Poland	00315
2	Mother and Child Health Center of Warsaw Medical University	Warsaw	Poland	02015
3	Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital	Warsaw	Poland	02091
4	Warsaw Medical University - Clinic of Neonatology	Warsaw	Poland	02091

Sponsors and Collaborators

Medical University of Warsaw
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Maria Katarzyna Kornacka, Professor of Neonatology, Medical University of Warsaw

ClinicalTrials.gov Identifier:

NCT03341481

Other Study ID Numbers:

FEMA/01/2014

First Posted:

Nov 14, 2017

Last Update Posted:

Jun 28, 2019

Last Verified:

Nov 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Maria Katarzyna Kornacka, Professor of Neonatology, Medical University of Warsaw

galactagogues, lactogenesis, preterm labor

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Jun 28, 2019