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

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ClinicalTrials.gov Identifier: NCT01430728
Recruitment Status : Recruiting
First Posted : September 8, 2011
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Infant, Very Low Birth Weight

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
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Study Type : Observational
Estimated 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 : April 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Very low birthweight infants


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Cerebral tissue oxygen saturation during first 72 hours of life [ Time Frame: during first 72 hours of life ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Very low birthweight infants treated in our hospital
Criteria

Inclusion Criteria:

  • Very low birthweight infants
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430728


Contacts
Contact: Manuel B Schmid, Dr. med. +49 731 500 ext 57218 manuel.schmid@uniklinik-ulm.de

Locations
Germany
University Medical Center Recruiting
Ulm, Baden-Württemberg, Germany, 89075
Contact: Manuel B Schmid, Dr. med.    +49 731 500 ext 57218    manuel.schmid@uni-ulm.de   
Principal Investigator: Manuel B Schmid, Dr. med.         
Sub-Investigator: Hans W Fuchs, Dr. med.         
Sub-Investigator: Reinhard J Hopfner, Dr. med.         
Sub-Investigator: Helmut D Hummler, Dr. med.         
Sub-Investigator: Wolfgang Lindner, Dr. med.         
Sponsors and Collaborators
University of Ulm
Investigators
Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01430728     History of Changes
Other Study ID Numbers: ULMNEONIRS04
First Posted: September 8, 2011    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms