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

This study is currently recruiting participants.
Verified April 2016 by Manuel Schmid, University of Ulm
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430728
First Posted: September 8, 2011
Last Update Posted: April 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Manuel Schmid, University of Ulm
  Purpose
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
Infant, Very Low Birth Weight

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours

Resource links provided by NLM:


Further study details as provided by Manuel Schmid, University of Ulm:

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

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Very low birthweight infants

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.

  Eligibility

Information from the National Library of Medicine

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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
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

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

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