Clinical trial NCT03341481: Effectiveness of Femaltiker in Stimulation Lactation Among Mothers of Preterm Infants
Official title: Effectiveness of a Dietary Supplement Femaltiker in Improvement of Initiation and Stimulation Lactation Among Mothers of Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lactation Induced
Keywords: galactagogues, lactogenesis, preterm labor
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Human Milk Bank Foundation
name: Nutropharma LLC
First posted: 2017-11-14
Enrollment: 109
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The volume of milk produced by study participants
timeFrame: two weeks after delivery
measure: Level of serum prolactin
timeFrame: two weeks after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Warsaw Medical University Hospital
city: Warsaw
country: Poland
facility: Mother and Child Health Center of Warsaw Medical University
city: Warsaw
country: Poland
facility: Laboratory of Human Milk and Lactation Research at Regional Human Milk Bank in Holy Family Hospital
city: Warsaw
country: Poland
facility: Warsaw Medical University - Clinic of Neonatology
Study officials:
affiliation: Warsaw Medical University, Department of Neonatology
name: Aleksandra Wesolowska, PhD
role: STUDY_DIRECTOR
affiliation: Warsaw Medical University Hospital, Department of Neonatology and Intensive Care Unit
name: Maria K. Borszewska-Kornacka, Prof.
role: PRINCIPAL_INVESTIGATOR
References: