Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk

Hydrocephalus in Infants Clinical Trial

— NAMU  

Official title:

Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04229693
• Other study ID #: UHC_NAMU
• Status: Recruiting
• Start date: February 7, 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: University Hospital of Cologne
• Contact: Titus Keller, MD
• Phone: 0049 221 4449
• Email: titus.keller[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• preterm infant with hydrocephalus and regular drainage

Exclusion Criteria:

• Inborn error of metabolism

Related Conditions & MeSH terms

• Hydrocephalus
• Hydrocephalus in Infants

Intervention

Other:
• no intervention
no intervention, only observational.

Locations

Country	Name	City	State
Germany	Neonatology at the University Hospital of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Keller T, Körber 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrospinal fluid proteom	Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application	weeks