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Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life

Sponsor
University of Ulm (Other)
Overall Status
Unknown status
CT.gov ID
NCT01430728
Collaborator
(none)
200
Enrollment
1
Location
98
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to examine the range of cerebral tissue oxygen saturation in healthy and sick very low birthweight infants during the first 72 hours of life.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In this observational trial we want to examine cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD as measured by near infrared spectroscopy during the first 72h of life in very low birthweight infants.

    Differences between relatively healthy and sick preterm infants will be explored. A focus is to find differences between those infants who develop germinal matrix hemorrhage and those who are at risk only but do not develop hemorrhage.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours
    Study Start Date :
    Apr 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Jun 1, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Very low birthweight infants

    Outcome Measures

    Primary Outcome Measures

    1. Cerebral tissue oxygen saturation during first 72 hours of life [during first 72 hours of life]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Very low birthweight infants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Ulm Baden-Württemberg Germany 89075

    Sponsors and Collaborators

    • University of Ulm

    Investigators

    • Principal Investigator: Manuel B Schmid, Dr. med., University of Ulm

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manuel Schmid, Dr. med., University of Ulm
    ClinicalTrials.gov Identifier:
    NCT01430728
    Other Study ID Numbers:
    • ULMNEONIRS04
    First Posted:
    Sep 8, 2011
    Last Update Posted:
    Apr 6, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Birth Weight

    Study Results

    No Results Posted as of Apr 6, 2016