LactationBMProfileNCT02662517
Growth Hormones and Cells in Human Milk Depending on Gestational Age
An observational study of Lactation, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Lactation
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2016to 1 Jan 2017
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breastfeeding mothers
Who may be able to join
- the newborn infant is being fed with own mothers milk
Who cannot join
- low amount of breast milk
Trial locations and contacts
1 site in 1 country.
Germany1 site
Neonatology at the University Hospital of Cologne
Cologne, 50937
About this study
Official title: Growth Hormones and Cells in Human Milk Depending on Gestational Age and Lactation Phase
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.
Read the detailed description
Neurotrophins (epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF)) as well as amount of cells, especially positive for sex-determining transformer protein (TRA)-1-81 and stage-specific embryonic antigen (SSEA)-4, are planned to be quantified in human breast milk of extremely preterm newborns as well as term newborns at different stages of lactation.
- Conditions
- Lactation
- Keywords
- Neurotrophins, Stem Cells, Prematurity
- Medical subject headings
- Breast Feeding, Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
neurotrophins composition
Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk
Measured: day 7
Secondary outcomes (1)
Amount of cells positive for surface markers TRA-1-81 and SSEA-4
surface markers characteristic for pluripotent stem cells
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2016 (estimated)
- Study start1 Mar 2016
- Primary completion30 Sep 2016
- Study completion1 Jan 2017
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 LactationStudies 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Titus Keller, MD, University Hospital of Cologne
- Investigators
- Titus Keller, MD, Principal investigator, Neonatology, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02662517
- Sponsor's protocol ID
- UHCologne
- Acronym
- BMProfile
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Keller T, Wengenroth L, Smorra D, Probst K, Kurian L, Kribs A, Brachvogel B. Novel DRAQ5/SYTOX(R) Blue Based Flow Cytometric Strategy to Identify and Characterize Stem Cells in Human Breast Milk. Cytometry B Clin Cytom. 2019 Nov;96(6):480-489. doi: 10.1002/cyto.b.21748. Epub 2018 Nov 26.
PubMed 30479054
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Hormones and Cells in Human Milk Depending on Gestational Age and Lactation Phase
- ClinicalTrials.gov ID
- NCT02662517
- Acronym / sponsor ID
- BMProfile / UHCologne
- Conditions
- Lactation
- Keywords
- Neurotrophins, Stem Cells, Prematurity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 1 Mar 2016
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 25 Jan 2016 (estimated)
- 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.
Human breast milk contains growth factors including neurotrophins and cells with neuroprotective potential. Concerning growth factors milk of preterms differs significantly from term milk. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.
Detailed description
Neurotrophins (epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), nerve growth factor (NGF), brain derived neurotrophic factor (BDNF)) as well as amount of cells, especially positive for sex-determining transformer protein (TRA)-1-81 and stage-specific embryonic antigen (SSEA)-4, are planned to be quantified in human breast milk of extremely preterm newborns as well as term newborns at different stages of lactation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breastfeeding mothers
Key inclusion criteria (1 listed)
- the newborn infant is being fed with own mothers milk
Key exclusion criteria (1 listed)
- low amount of breast milk
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neurotrophins composition
Time frame: day 7
Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk
1 secondary outcome
Amount of cells positive for surface markers TRA-1-81 and SSEA-4
Time frame: day 7
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 18 Jan 2020.
- Results publication: PubMed 30479054Keller T, Wengenroth L, Smorra D, Probst K, Kurian L, Kribs A, Brachvogel B. Novel DRAQ5/SYTOX(R) Blue Based Flow Cytometric Strategy to Identify and Characterize Stem Cells in Human Breast Milk. Cytometry B Clin Cytom. 2019 Nov;96(6):480-489. doi: 10.1002/cyto.b.21748. Epub 2018 Nov 26.
- Individual participant dataSharing planned: No
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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.
Titus Keller, MD principal investigator
Neonatology, University Hospital of Cologne
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 Lactation, run by University Hospital of Cologne at 1 site in Germany.
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 1 inclusion and 1 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 18 Jan 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 Germany. 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?
neurotrophins composition (time frame: day 7). 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 NCT02662517, 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 18 Jan 2020.