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

• Conditions: Infant, Very Low Birth Weight

• Registration Number: NCT01430728
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-09-06
• Study First Submitted QC: 2011-09-07
• Study First Posted: 2011-09-08
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-05
• Last Update Posted: 2016-04-06
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Very low birthweight infants

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebral tissue oxygen saturation during first 72 hours of life	during first 72 hours of life

Trial Locations

Locations (1)

University Medical Center; 🇩🇪 Ulm, Baden-Württemberg, Germany