NCT04229693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
20 days until next milestone

Study Start

First participant enrolled

February 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

January 13, 2020

Last Update Submit

February 7, 2020

Conditions

Hydrocephalus in Infants

Outcome Measures

Primary Outcomes (1)

  • Cerebrospinal fluid proteom

    Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application

    weeks

Interventions

no interventionOTHER

no intervention, only observational.

Eligibility Criteria

Age3 Days - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • preterm infant with hydrocephalus and regular drainage

You may not qualify if:

  • Inborn error of metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatology at the University Hospital of Cologne

Cologne, 50937, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 30386923BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid samples which are collected after routine drainage via ventricle reservoir

Study Officials

  • Titus Keller, MD

    University of Cologne, Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Titus Keller, MD

CONTACT

0049 221 4449titus.keller@uk-koeln.de

Angela Kribs, MD

CONTACT

0049 221 5998angela.kribs@uk-koeln.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

February 7, 2020

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)