Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk

NCT ID: NCT04229693

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-07

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

Conditions

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Hydrocephalus in Infants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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no intervention

no intervention, only observational.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* preterm infant with hydrocephalus and regular drainage

Exclusion Criteria

* Inborn error of metabolism
Minimum Eligible Age

3 Days

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Titus Keller, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Titus Keller, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cologne, Children's Hospital

Locations

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Neonatology at the University Hospital of Cologne

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Titus Keller, MD

Role: CONTACT

0049 221 4449

Angela Kribs, MD

Role: CONTACT

0049 221 5998

Facility Contacts

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Titus Keller, MD

Role: primary

0049 221 478 5998

Angela Kribs, MD

Role: backup

0049 221 478 5064

References

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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.

Reference Type BACKGROUND
PMID: 30386923 (View on PubMed)

Other Identifiers

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UHC_NAMU

Identifier Type: -

Identifier Source: org_study_id

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