Factors Influencing the Composition of Human Milk

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Milk Collection
• Intervention / Treatment: Device: Analysis of human milk composition by mid-infrared spectrophotometry

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 174

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08406
    • Neonatal centre of Vilnius University Hospital Santaros Klinikos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Mothers of newborns admitted at Neonatal Center of Vilnius University Hospital Santaros Klinikos, Lithuania

Description

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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Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mothers of extremely preterm infants; (gestational age < 28 weeks)	Device: Analysis of human milk composition by mid-infrared spectrophotometry; 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.; Other Names: Holder pasteurisation
Mothers of very preterm infants; (gestational age 28 - 31 weeks)	Device: Analysis of human milk composition by mid-infrared spectrophotometry; 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.; Other Names: Holder pasteurisation
Mothers of moderate and late preterm infants; (gestational age 32 - 36 weeks)	Device: Analysis of human milk composition by mid-infrared spectrophotometry; 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.; Other Names: Holder pasteurisation
Mothers of term infants; (gestational age ≥ 37 weeks)	Device: Analysis of human milk composition by mid-infrared spectrophotometry; 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.; Other Names: Holder pasteurisation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University
• Collaborators: University of Cagliari
• Investigators: Study Director: Vytautas Usonis, MD, Vilnius University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): June 4, 2020
• Last Update Submitted That Met QC Criteria: June 2, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: MPS-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No