Clinical trial NCT02384655: Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
Official title: Effect of Fenugreek Use in Mothers of Preterm on Breast Milk Production and Macronutrient Content
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Preterms
Lactation
Keywords: Preterms
Breastfeeding
Lactation
Macronutrients
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-10
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Feeding human milk to preterm infants does reduce the risk of serious and costly neonatal intensive care unit acquired morbidity such as NEC and the late onset sepsis.

It is often difficult to obtain sufficient quantities of human milk from mothers of preterm infants most of whom are breast pump-dependent for weeks or months. Mothers will try to use galactogogues in an attempt to increase milk production. Fenugreek (Trigonella foenum-graecum) seeds is the most commonly used herbal galactogogue and is a member of the pea family. Our experience at the NICU is that around 30% of preterm mothers desperately looking for ways to increase their breast milk supply will eventually took fenugreek (Hilbe) as food supplement. Although widely recommended, there is limited evidence to support the effectiveness of fenugreek as a galactogogue.

The aims of this study are to evaluate whether maternal consumption of fenugreek seeds has any effect on macronutrients composition of breast milk and whether fenugreek is transferred to the infant via mother milk. In addition any changes in mother and infant health status will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy mothers 7 to 14 days postpartum,
* Mothers of preterm infants under 38 weeks of gestation,
* Mothers with poor milk supply documented by professional lactation consultants.

Exclusion Criteria:

* Mothers with mastitis,
* Mothers with breast engorgement,
* Mothers currently consuming Reglan, Domperidone or other drugs/herbals used to induce milk production,
* Mothers who are taking medications (Diuretics, Pseudoephedrine, - Anticholinergics, Warfarin or any anticoagulant, An estrogen-containing birth control pill),
* Mothers with Diabetes mellitus,
* Mothers who have had breast surgery that could alter milk synthesis or production,
* Mothers diagnosed with Polycystic Ovary Syndrome,
* Mothers diagnosed with Asthma or atopic disease,
* Mothers who are known to be allergic to peanuts or soybeans,
* Mothers whose milk supply per 24 hours exceeds 600 mL,
* Mothers with hypo/hyperthyroidism

Primary outcomes:
measure: Change in daily volume of expressed milk
timeFrame: at day 0, 3, 7, 10, 14
Secondary outcomes:
measure: Change in Macronutrient content analysis of breastmilk
timeFrame: at day 0, 3, 7, 14
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Department of Neonatology Tel Aviv Medical Center
Study officials:
affiliation: Department of Neonatology, Lis Maternity Hospital, Tel Aviv Medical Center
name: Ronella Marom, MD
role: PRINCIPAL_INVESTIGATOR
References: