Growth Hormones and Cells in Human Milk Depending on Gestational Age (BMProfile)

January 13, 2020 updated by: Titus Keller, MD, University Hospital of Cologne

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany, 50937
        • Neonatology at the University Hospital of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Breastfeeding mothers

Description

Inclusion Criteria:

  • the newborn infant is being fed with own mothers milk

Exclusion Criteria:

  • low amount of breast milk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurotrophins composition
Time Frame: day 7
Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk
day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amount of cells positive for surface markers TRA-1-81 and SSEA-4
Time Frame: day 7
surface markers characteristic for pluripotent stem cells
day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Cologne

Investigators

  • Principal Investigator: Titus Keller, MD, Neonatology, University Hospital of Cologne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 25, 2016

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 13, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UHCologne

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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