Breast Milk CollectionNCT04382989
Factors Influencing the Composition of Human Milk
An observational study of Breast Milk Collection, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Milk Collection
- What is being tested?
- Analysis of human milk composition by mid-infrared spectrophotometry
- Type of treatment
- Medical device
- How many people
- 174 participants
- Where
- 1 siteLithuania
- Study dates
- 15 Sep 2017to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Mothers of newborns admitted at Neonatal Center of Vilnius University Hospital Santaros Klinikos, Lithuania
Who may be able to join
- 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.
- -
Who cannot join
- breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.
- -
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Neonatal centre of Vilnius University Hospital Santaros Klinikos
Vilnius, 08406
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Milk Collection
- Being tested
- Analysis of human milk composition by mid-infrared spectrophotometry
- Medical subject headings
- Breast Milk Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of human milk composition by mid-infrared spectrophotometryDevice
Also called Holder pasteurisation
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.
| Study group | Role | What they receive |
|---|---|---|
| Mothers of extremely preterm infants | (gestational age < 28 weeks) Receives: Device: Analysis of human milk composition by mid-infrared spectrophotometry | |
| Mothers of very preterm infants | (gestational age 28 - 31 weeks) Receives: Device: Analysis of human milk composition by mid-infrared spectrophotometry | |
| Mothers of moderate and late preterm infants | (gestational age 32 - 36 weeks) Receives: Device: Analysis of human milk composition by mid-infrared spectrophotometry | |
| Mothers of term infants | (gestational age ≥ 37 weeks) Receives: Device: Analysis of human milk composition by mid-infrared spectrophotometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of total protein concentration in human milk
Mid-infrared spectrophotometry
Measured: from the 2nd week, up to 2 months after delivery
Secondary outcomes (4)
Quantification of total lipids and carbohydrate in human milk
Mid-infrared spectrophotometry
Measured: from the 2nd week, up to 2 months after delivery
Quantification of lactoferrin in human milk
An immune-enzymatic ELISA assay
Measured: 14-16 days after delivery
Quantification of lysozyme in human milk
An immune-enzymatic ELISA assay
Measured: 14-16 days after delivery
Human milk metabolome analysis
Nuclear Magnetic Resonance (NMR) analysis
Measured: 15-17 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start15 Sep 2017
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Milk CollectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cagliari
- Responsible party
- Sponsor
- Investigators
- Vytautas Usonis, MD, Study director, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382989
- Sponsor's protocol ID
- MPS-2017
- Status last verified
- Jun 2020
- First submitted
- 6 May 2020
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32856945
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women
- ClinicalTrials.gov ID
- NCT04382989
- Acronym / sponsor ID
- MPS-2017
- Conditions
- Breast Milk Collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- University of Cagliari
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mothers of extremely preterm infants | – | Device: Analysis of human milk composition by mid-infrared spectrophotometry(gestational age < 28 weeks) |
| Mothers of very preterm infants | – | Device: Analysis of human milk composition by mid-infrared spectrophotometry(gestational age 28 - 31 weeks) |
| Mothers of moderate and late preterm infants | – | Device: Analysis of human milk composition by mid-infrared spectrophotometry(gestational age 32 - 36 weeks) |
| Mothers of term infants | – | Device: Analysis of human milk composition by mid-infrared spectrophotometry(gestational age ≥ 37 weeks) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Mothers of newborns admitted at Neonatal Center of Vilnius University Hospital Santaros Klinikos, Lithuania
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of human milk composition by mid-infrared spectrophotometryAlso: Holder pasteurisationAnalysis 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. | Device | Mothers of extremely preterm infants, Mothers of moderate and late preterm infants, Mothers of term infants, Mothers of very preterm infants |
Primary outcome
Quantification of total protein concentration in human milk
Time frame: from the 2nd week, up to 2 months after delivery
Mid-infrared spectrophotometry
4 secondary outcomes
Quantification of total lipids and carbohydrate in human milk
Time frame: from the 2nd week, up to 2 months after delivery
Quantification of lactoferrin in human milk
Time frame: 14-16 days after delivery
Quantification of lysozyme in human milk
Time frame: 14-16 days after delivery
Human milk metabolome analysis
Time frame: 15-17 days after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Derived from this study: PubMed 32856945Paulaviciene 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.
- Individual participant dataSharing planned: No
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Impact of Breast Milk on the Infectivity and Transmission of Different Viruses "BREASTMILKVIR"
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vytautas Usonis, MD study director
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Milk Collection, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of total protein concentration in human milk (time frame: from the 2nd week, up to 2 months after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04382989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.