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Completed

NCT Number: NCT02662517

Growth Hormones and Cells in Human Milk Depending on Gestational Age

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.

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Key information

Conditions

Lactation Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Neonatology at the University Hospital of Cologne

Cologne, 50937, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the newborn infant is being fed with own mothers milk

Exclusion criteria

  • low amount of breast milk

Treatment and study plan

Primary outcomes

  1. neurotrophins composition

    Time frame: day 7

    Concentration of Neurotrophins EGF, VEGF, NGF, BDNF in the human milk

Secondary outcomes

  1. Amount of cells positive for surface markers TRA-1-81 and SSEA-4

    Time frame: day 7

    surface markers characteristic for pluripotent stem cells

Sponsors and collaborators

Lead sponsor

University Hospital of Cologne

Other

Registry information

Official study title

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

Acronym: BMProfile

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jan 25, 2016
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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