NCT04382989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2.6 years

First QC Date

May 6, 2020

Last Update Submit

June 2, 2020

Conditions

Breast Milk Collection

Outcome Measures

Primary Outcomes (1)

  • Quantification of total protein concentration in human milk

    Mid-infrared spectrophotometry

    from the 2nd week, up to 2 months after delivery

Secondary Outcomes (4)

  • Quantification of total lipids and carbohydrate in human milk

    from the 2nd week, up to 2 months after delivery

  • Quantification of lactoferrin in human milk

    14-16 days after delivery

  • Quantification of lysozyme in human milk

    14-16 days after delivery

  • Human milk metabolome analysis

    15-17 days after delivery

Study Arms (4)

Mothers of extremely preterm infants

(gestational age \< 28 weeks)

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of very preterm infants

(gestational age 28 - 31 weeks)

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of moderate and late preterm infants

(gestational age 32 - 36 weeks)

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Mothers of term infants

(gestational age ≥ 37 weeks)

Device: Analysis of human milk composition by mid-infrared spectrophotometry

Interventions

Analysis of human milk composition by mid-infrared spectrophotometryDEVICE

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.

Also known as: Holder pasteurisation
Mothers of extremely preterm infantsMothers of moderate and late preterm infantsMothers of term infantsMothers of very preterm infants

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsLactating women
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal centre of Vilnius University Hospital Santaros Klinikos

Vilnius, 08406, Lithuania

Location

Related Publications (1)

  • 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.

    PMID: 32856945DERIVED

MeSH Terms

Conditions

Breast Milk Expression

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Study Officials

  • Vytautas Usonis, MD

    Vilnius University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

September 15, 2017

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

June 4, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)