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NCT02662517 Clinical Trial

Growth Hormones and Cells in Human Milk Depending on Gestational Age

Lactation Clinical Trial

— BMProfile  

Official title:
Growth Hormones and Cells in Human Milk Depending on Gestational Age and Lactation Phase

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02662517
Other study ID # UHCologne
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2016
Est. completion date January 1, 2017

Study information
Verified date January 2020
Source University Hospital of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. The aim of this study is to give a profile of human milk concerning non-nutritive factors depending on gestational age and lactation phase.

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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date January 1, 2017
Est. primary completion date September 30, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- the newborn infant is being fed with own mothers milk

Exclusion Criteria:

- low amount of breast milk

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Neonatology at the University Hospital of Cologne Cologne

Sponsors (1)
Lead Sponsor Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Keller T, Wengenroth L, Smorra D, Probst K, Kurian L, Kribs A, Brachvogel B. Novel DRAQ5™/SYTOX® 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 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary neurotrophins composition Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk day 7
Secondary Amount of cells positive for surface markers TRA-1-81 and SSEA-4 surface markers characteristic for pluripotent stem cells day 7
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