Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

NCT ID: NCT03341481

Last Updated: 2019-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-11-30

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.

Conditions

Lactation Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Femaltiker

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

Group Type: EXPERIMENTAL

Femaltiker

Intervention Type: OTHER

Patient had taken twice a day the product

placebo

7.7 g placebo 14 days of the trial.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Patient had taken twice a day the placebo

Interventions

Femaltiker

Patient had taken twice a day the product

Intervention Type: OTHER

Placebo

Patient had taken twice a day the placebo

Intervention Type: OTHER

Other Intervention Names

LACTANELL formula

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Human Milk Bank Foundation

UNKNOWN

Sponsor Role: collaborator

Nutropharma LLC

UNKNOWN

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Maria Katarzyna Kornacka

Professor of Neonatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aleksandra Wesolowska, PhD

Role: STUDY_DIRECTOR

Warsaw Medical University, Department of Neonatology

Maria K. Borszewska-Kornacka, Prof.

Role: PRINCIPAL_INVESTIGATOR

Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit

Locations

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

Warsaw Medical University - Clinic of Neonatology

Warsaw, , Poland

Countries

Poland

Other Identifiers

FEMA/01/2014

Identifier Type: -

Identifier Source: org_study_id