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

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2016 by University of Ulm

Sponsor:

Information provided by (Responsible Party):

Manuel Schmid, University of Ulm

ClinicalTrials.gov Identifier:

NCT01430728

First received: September 6, 2011

Last updated: April 5, 2016

Last verified: April 2016

History of Changes

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:

MedlinePlus related topics: Birth Weight Body Weight

U.S. FDA Resources

Further study details as provided by University of Ulm:

Primary Outcome Measures:

Cerebral tissue oxygen saturation during first 72 hours of life [ Time Frame: during first 72 hours of life ] [ Designated as safety issue: No ]


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


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 6, 2011
Last Updated:	April 5, 2016
Health Authority:	Germany: Ethics Commission

Additional relevant MeSH terms:


Birth Weight Body Weight Signs and Symptoms

ClinicalTrials.gov processed this record on September 23, 2016

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