Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants

NCT03341481 | Completed

• 1 other identifier: FEMA/01/2014
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 4

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.

Conditions

Lactation Induced

Keywords

galactagogues, lactogenesis, preterm labor

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Femaltiker

EXPERIMENTAL

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

Other: Femaltiker

placebo

PLACEBO COMPARATOR

7.7 g placebo 14 days of the trial.

Other: Placebo

Interventions

Femaltiker OTHER

Patient had taken twice a day the product

Also known as: LACTANELL formula

Femaltiker

Placebo OTHER

Patient had taken twice a day the placebo

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mothers of preterm infants (born before 37 completed weeks of pregnancy)

You may not qualify if:

• hypothyroidism
• diabetes type I or II diagnosed and treated before pregnancy
• participating in other study

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Human Milk Bank Foundation: collaborator
• Nutropharma LLC: collaborator

Study Sites (4)

Warsaw Medical University Hospital

Warsaw, 00315, Poland

Location

Mother and Child Health Center of Warsaw Medical University

Warsaw, 02015, Poland

Location

Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital

Warsaw, 02091, Poland

Location

Warsaw Medical University - Clinic of Neonatology

Warsaw, 02091, Poland

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Aleksandra Wesolowska, PhD

  Warsaw Medical University, Department of Neonatology

  STUDY DIRECTOR

• Maria K. Borszewska-Kornacka, Prof.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neonatology

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2017
• First Posted: November 14, 2017
• Study Start: April 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: June 28, 2019

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)