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Factors Influencing the Composition of Human Milk

V

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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