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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 : Unknown
Verified April 2016 by Manuel Schmid, University of Ulm.
Recruitment status was:  Recruiting
First Posted : September 8, 2011
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm

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.

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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

Very low birthweight infants

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Very low birthweight infants

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

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

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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
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Principal Investigator: Manuel B Schmid, Dr. med. University of Ulm
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Manuel Schmid, Dr. med., University of Ulm
ClinicalTrials.gov Identifier: NCT01430728    
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:
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Birth Weight
Body Weight