Cerebral Tissue Oxygenation in Very Low Birthweight Infants in the First 3 Days of Life
![]() |
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. |
ClinicalTrials.gov Identifier: NCT01430728 |
Recruitment Status
:
Recruiting
First Posted
: September 8, 2011
Last Update Posted
: April 6, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Infant, Very Low Birth Weight |
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 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 |

Group/Cohort |
---|
Very low birthweight infants |
- Cerebral tissue oxygen saturation during first 72 hours of life [ Time Frame: during first 72 hours of life ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
- Very low birthweight infants

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
Contact: Manuel B Schmid, Dr. med. | +49 731 500 ext 57218 | manuel.schmid@uniklinik-ulm.de |
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. |
Principal Investigator: | Manuel B Schmid, Dr. med. | University of Ulm |
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 |