Cerebrospinal Fluid Proteom in Dependence of Intranasal B... | NCT04229693

Studies
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk

NCT04229693

Sponsor

University Hospital of Cologne

Status

Unknown status

Last Update Posted

Feb 11, 2020Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Hydrocephalus in Infants

Interventions

no intervention

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

Feb 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2020Actual

Primary Completion Date

Feb 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Jan 13, 2020

First Submission Date that Met QC Criteria

Jan 13, 2020

First Posted Date

Jan 18, 2020Actual

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

Feb 7, 2020

Last Update Posted Date

Feb 11, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Titus Keller, MD, Principal Investigator, University Hospital of ColognePrincipal Investigator

Lead Sponsor

University Hospital of CologneOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

Investigation of the cerebrospinal fluid proteom in preterm infants with posthemorrhagic hydrocephalus in our neonatology center with analysis for modulation of proteom in dependence of breastmilk feeding and way of application such as via gavage tube, oral or nasal application.

Detailed Description

Since the nasal route might be highly effective for neurotrophins and other growth factors the cerebrospinal fluid will be investigated using mass spectrometry to identify modulating effects of intranasal breast milk application on the cerebrospinal fluid proteom.

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

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention, only observational.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebrospinal fluid proteom	Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application	weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

preterm infant with hydrocephalus and regular drainage

Exclusion Criteria:

Inborn error of metabolism

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Days

Maximum Age

12 Months

Standard Ages

Child

Study Population

All preterm infants at our neonatologic center with hydrocephalus in need of drainage are eligible.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Titus Keller, MD	Contact	0049 221 4449		titus.keller@uk-koeln.de
Angela Kribs, MD	Contact	0049 221 5998		angela.kribs@uk-koeln.de

Overall Officials

Name	Affiliation	Role
Titus Keller, MD	University of Cologne, Children's Hospital	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30386923	Background	Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1.