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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT03213275
Date of registration: 05/07/2017
Prospective Registration: Yes
Primary sponsor: Medical University of Vienna
Public title: The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury PreMiBraIn
Scientific title: The Premature Gut Microbiome and the Influence on Neonatal Immunity, Brain Development and White Matter Injury
Date of first enrolment: October 11, 2017
Target sample size: 60
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT03213275
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Austria
Contacts
Name:     Lukas Wisgrill, M.D.
Address: 
Telephone:
Email:
Affiliation:  Medical University of Vienna
Key inclusion & exclusion criteria

Inclusion Criteria:

- Gestational age < 28+0 weeks

- Birth weight < 1000 gram

Exclusion Criteria:

- chromosomal aberrations

- congenital malformations

- inborn metabolic disorders

- maternal chronic infectious diseases

- missing informed consent



Age minimum: N/A
Age maximum: 2 Days
Gender: All
Health Condition(s) or Problem(s) studied
Neurodevelopment Outcome
Immunology
Microbiome
Intervention(s)
Other: Microbiome Sequencing, Neurophysiologic Assessment, Immunological test
Primary Outcome(s)
Neurodevelopmental outcome with corrected age of two and five years [Time Frame: Eight Years]
Secondary Outcome(s)
Secondary ID(s)
PreMiBraIn
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Vienna
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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