Hydrocephalus in InfantsNAMUNCT04229693
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk
An observational study of Hydrocephalus in Infants, run by University Hospital of Cologne at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 3 days to 12 months
- Conditions the study is for
- Hydrocephalus in Infants
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 7 Feb 2020to Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 12 months
- All sexes
- No healthy volunteers
- Child
Study population: All preterm infants at our neonatologic center with hydrocephalus in need of drainage are eligible.
Who may be able to join
- preterm infant with hydrocephalus and regular drainage
Who cannot join
- Inborn error of metabolism
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Neonatology at the University Hospital of Cologne
Cologne, 50937
Titus Keller, MD, 0049 221 478 5998, titus.keller@uk-koeln.de
Angela Kribs, MD, 0049 221 478 5064, angela.kribs@uk-koeln.de
About this study
Official title: Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.
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.
Read the 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.
- Conditions
- Hydrocephalus in Infants
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, only observational.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrospinal fluid proteom
Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application
Measured: weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start7 Feb 2020
- Primary completionFeb 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus in InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Titus Keller, MD, University Hospital of Cologne
- Investigators
- Titus Keller, MD, Principal investigator, University of Cologne, Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229693
- Sponsor's protocol ID
- UHC_NAMU
- Acronym
- NAMU
- Status last verified
- Feb 2020
- First submitted
- 13 Jan 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30386923
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.
- ClinicalTrials.gov ID
- NCT04229693
- Acronym / sponsor ID
- NAMU / UHC_NAMU
- Conditions
- Hydrocephalus in Infants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 7 Feb 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 days to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All preterm infants at our neonatologic center with hydrocephalus in need of drainage are eligible.
Key inclusion criteria (1 listed)
- preterm infant with hydrocephalus and regular drainage
Key exclusion criteria (1 listed)
- Inborn error of metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention, only observational. | Other | – |
Primary outcome
Cerebrospinal fluid proteom
Time frame: weeks
Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: PubMed 30386923Keller 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Titus Keller, MD principal investigator
University of Cologne, Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus in Infants, run by University Hospital of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Titus Keller, MD (0049 221 4449, titus.keller@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrospinal fluid proteom (time frame: weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04229693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.