Growth Hormones and Cells in Human Milk Depending on Gestational Age

Completed

• Conditions: Lactation

• Registration Number: NCT02662517
• Lead Sponsor: University Hospital of Cologne

Brief 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.

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 Timeline

• Study First Submitted: 2016-01-11
• Study First Submitted QC: 2016-01-20
• Study First Posted: 2016-01-25
• Study Start: 2016-03-01
• Primary Completion: 2016-09-30
• Study Completion: 2017-01-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

• the newborn infant is being fed with own mothers milk

Exclusion Criteria

• low amount of breast milk

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
neurotrophins composition	day 7	Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk

Secondary Outcome Measures

Name	Time	Method
Amount of cells positive for surface markers TRA-1-81 and SSEA-4	day 7	surface markers characteristic for pluripotent stem cells

Trial Locations

Locations (1)

Neonatology at the University Hospital of Cologne; 🇩🇪 Cologne, Germany