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| Name | Class |
|---|---|
| University of Cagliari | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mothers of extremely preterm infants | (gestational age < 28 weeks) |
| |
| Mothers of very preterm infants | (gestational age 28 - 31 weeks) |
| |
| Mothers of moderate and late preterm infants | (gestational age 32 - 36 weeks) |
| |
| Mothers of term infants | (gestational age ≥ 37 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analysis of human milk composition by mid-infrared spectrophotometry | Device | 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. |
| 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 |
| 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 |
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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.
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Exclusion Criteria:
breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.
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Lactating women
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Mothers of newborns admitted at Neonatal Center of Vilnius University Hospital Santaros Klinikos, Lithuania
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| Name | Affiliation | Role |
|---|---|---|
| Vytautas Usonis, MD | Vilnius University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neonatal centre of Vilnius University Hospital Santaros Klinikos | Vilnius | 08406 | Lithuania |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32856945 | Derived | Paulaviciene IJ, Liubsys A, Eidukaite A, Molyte A, Tamuliene L, Usonis V. The Effect of Prolonged Freezing and Holder Pasteurization on the Macronutrient and Bioactive Protein Compositions of Human Milk. Breastfeed Med. 2020 Sep;15(9):583-588. doi: 10.1089/bfm.2020.0219. Epub 2020 Aug 26. |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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|
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| 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 |