Factors Influencing the Composition of Human Milk

NCT ID: NCT04382989

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

174 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-15

Study Completion Date

2020-04-30

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.

Conditions

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Breast Milk Collection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mothers of extremely preterm infants

(gestational age \< 28 weeks)

Analysis of human milk composition by mid-infrared spectrophotometry

Intervention Type 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.

Mothers of very preterm infants

(gestational age 28 - 31 weeks)

Analysis of human milk composition by mid-infrared spectrophotometry

Intervention Type 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.

Mothers of moderate and late preterm infants

(gestational age 32 - 36 weeks)

Analysis of human milk composition by mid-infrared spectrophotometry

Intervention Type 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.

Mothers of term infants

(gestational age ≥ 37 weeks)

Analysis of human milk composition by mid-infrared spectrophotometry

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Holder pasteurisation

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.

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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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Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Cagliari

OTHER

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vytautas Usonis, MD

Role: STUDY_DIRECTOR

Vilnius University

Locations

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Neonatal centre of Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

References

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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.

Reference Type DERIVED
PMID: 32856945 (View on PubMed)

Other Identifiers

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MPS-2017

Identifier Type: -

Identifier Source: org_study_id

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