Factors Influencing the Composition of Human Milk

Vilnius University

Status: Completed

Conditions: Breast Milk Collection

Treatments: Device: Analysis of human milk composition by mid-infrared spectrophotometry

Study type: Observational

Funder types: Other

Identifiers

NCT04382989

MPS-2017

Details and patient eligibility

About

This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence human milk composition.

Full description

The study consists of three parts. In the first part the investigators aim to evaluate human milk macronutrient composition depending on the time after delivery and pregnancy duration.

In the second part the investigators aim to evaluate the circadian variation of human milk macronutrient and energy content depending on pregnancy duration.

In the third part the investigators aim to evaluate the influence of Holder pasteurisation on human milk macronutrient, metabolome and bioactive protein (lysozyme and lactoferrin) content.

Enrollment: 174 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

having obtained informed consent; after a single-birth pregnancy; women who were not on a special diet; lactating mothers who could not breastfeed their newborns due to the baby's medical condition (either prematurity or disease) but who expressed milk.

Exclusion criteria

breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.

Trial design

174 participants in 4 patient groups

Mothers of extremely preterm infants

Description:

(gestational age \< 28 weeks)

Treatment:

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of very preterm infants

Description:

(gestational age 28 - 31 weeks)

Treatment:

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of moderate and late preterm infants

Description:

(gestational age 32 - 36 weeks)

Treatment:

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of term infants

Description:

(gestational age ≥ 37 weeks)

Treatment:

Device: Analysis of human milk composition by mid-infrared spectrophotometry