Factors Influencing the Composition of Human Milk

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women

Conditions
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Breast Milk Collection

Intervention / Treatment
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* Device: Analysis of human milk composition by mid-infrared spectrophotometry


Participation Criteria
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Eligibility Criteria
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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. -
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mothers of extremely preterm infants<br>(gestational age < 28 weeks) | Device: Analysis of human milk composition by mid-infrared spectrophotometry<br>* Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser. An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk.<br>* Other names: Holder pasteurisation;|
| Mothers of very preterm infants<br>(gestational age 28 - 31 weeks) | Device: Analysis of human milk composition by mid-infrared spectrophotometry<br>* Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser. An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk.<br>* Other names: Holder pasteurisation;|
| Mothers of moderate and late preterm infants<br>(gestational age 32 - 36 weeks) | Device: Analysis of human milk composition by mid-infrared spectrophotometry<br>* Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser. An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk.<br>* Other names: Holder pasteurisation;|
| Mothers of term infants<br>(gestational age ≥ 37 weeks) | Device: Analysis of human milk composition by mid-infrared spectrophotometry<br>* Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser. An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk.<br>* Other names: Holder pasteurisation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total protein concentration in human milk | Mid-infrared spectrophotometry | from the 2nd week, up to 2 months after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of total lipids and carbohydrate in human milk | Mid-infrared spectrophotometry | from the 2nd week, up to 2 months after delivery | 
| Quantification of lactoferrin in human milk | An immune-enzymatic ELISA assay | 14-16 days after delivery | 
| Quantification of lysozyme in human milk | An immune-enzymatic ELISA assay | 14-16 days after delivery | 
| Human milk metabolome analysis | Nuclear Magnetic Resonance (NMR) analysis | 15-17 days after delivery |