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Factors Influencing the Composition of Human Milk

Sponsor
Vilnius University (Other)
Overall Status
Completed
CT.gov ID
NCT04382989
Collaborator
University of Cagliari (Other)
174
Enrollment
1
Location
31.5
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
174 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women
Actual Study Start Date :
Sep 15, 2017
Actual Primary Completion Date :
Apr 30, 2020
Actual Study Completion Date :
Apr 30, 2020

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Quantification of total protein concentration in human milk [from the 2nd week, up to 2 months after delivery]

      Mid-infrared spectrophotometry

    Secondary Outcome Measures

    1. Quantification of total lipids and carbohydrate in human milk [from the 2nd week, up to 2 months after delivery]

      Mid-infrared spectrophotometry

    2. Quantification of lactoferrin in human milk [14-16 days after delivery]

      An immune-enzymatic ELISA assay

    3. Quantification of lysozyme in human milk [14-16 days after delivery]

      An immune-enzymatic ELISA assay

    4. Human milk metabolome analysis [15-17 days after delivery]

      Nuclear Magnetic Resonance (NMR) analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Neonatal centre of Vilnius University Hospital Santaros Klinikos Vilnius Lithuania 08406

    Sponsors and Collaborators

    • Vilnius University
    • University of Cagliari

    Investigators

    • Study Director: Vytautas Usonis, MD, Vilnius University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vilnius University
    ClinicalTrials.gov Identifier:
    NCT04382989
    Other Study ID Numbers:
    • MPS-2017
    First Posted:
    May 11, 2020
    Last Update Posted:
    Jun 4, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 4, 2020