Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 4:30 AM
Study NCT ID:
NCT04229693
Status:
UNKNOWN
Last Update Posted:
2020-02-11
First Post:
2020-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cerebrospinal fluid samples which are collected after routine drainage via ventricle reservoir'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-07', 'studyFirstSubmitDate': '2020-01-13', 'studyFirstSubmitQcDate': '2020-01-13', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebrospinal fluid proteom', 'timeFrame': 'weeks', 'description': 'Cerebrospinal fluid analysis using mass spectrometry including proteomic analysis for differences in dependence of intranasal breast milk application'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hydrocephalus in Infants']}, 'referencesModule': {'references': [{'pmid': '30386923', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '3 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All preterm infants at our neonatologic center with hydrocephalus in need of drainage are eligible.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preterm infant with hydrocephalus and regular drainage\n\nExclusion Criteria:\n\n* Inborn error of metabolism'}, 'identificationModule': {'nctId': 'NCT04229693', 'acronym': 'NAMU', 'briefTitle': 'Cerebrospinal Fluid Proteom in Dependence of Intranasal Breast Milk', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Cologne'}, 'officialTitle': 'Proteomics of Cerebrospinal Fluid of Preterm Infants With Posthemorrhagic Hydrocephalus With Focus on Intranasal Breast Milk.', 'orgStudyIdInfo': {'id': 'UHC_NAMU'}}, 'armsInterventionsModule': {'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'no intervention, only observational.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '50937', 'city': 'Cologne', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Titus Keller, MD', 'role': 'CONTACT', 'email': 'titus.keller@uk-koeln.de', 'phone': '0049 221 478 5998'}, {'name': 'Angela Kribs, MD', 'role': 'CONTACT', 'email': 'angela.kribs@uk-koeln.de', 'phone': '0049 221 478 5064'}], 'facility': 'Neonatology at the University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}], 'centralContacts': [{'name': 'Titus Keller, MD', 'role': 'CONTACT', 'email': 'titus.keller@uk-koeln.de', 'phone': '0049 221 4449'}, {'name': 'Angela Kribs, MD', 'role': 'CONTACT', 'email': 'angela.kribs@uk-koeln.de', 'phone': '0049 221 5998'}], 'overallOfficials': [{'name': 'Titus Keller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "University of Cologne, Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Titus Keller, MD', 'investigatorAffiliation': 'University Hospital of Cologne'}}}}