Growth Hormones and Cells in Human Milk Depending on Gest... | NCT02662517

Studies
Growth Hormones and Cells in Human Milk Depending on Gestational Age

NCT02662517

Sponsor

University Hospital of Cologne

Status

Completed

Last Update Posted

Jan 18, 2020Actual

Enrollment

43Actual

Phase

Not provided

Conditions

Lactation

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2016

Primary Completion Date

Sep 30, 2016Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Jan 11, 2016

First Submission Date that Met QC Criteria

Jan 20, 2016

First Posted Date

Jan 25, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2020

Last Update Posted Date

Jan 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

43Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the newborn infant is being fed with own mothers milk

Exclusion Criteria:

low amount of breast milk

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Breastfeeding mothers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Titus Keller, MD	Neonatology, University Hospital of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatology at the University Hospital of Cologne		Cologne		50937	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30479054	Result	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.

ID	Term
D001942	Breast Feeding
D047928	Premature Birth

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications