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

Infant, Very Low Birth Weight Clinical Trial

Official title:

Cerebral Tissue Oxygen Saturation in Preterm Neonates Below 1500g Birth Weight During the First 72 Hours

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01430728
• Other study ID #: ULMNEONIRS04
• Status: Recruiting
• Phase: N/A
• First received: September 6, 2011
• Last updated: April 5, 2016
• Start date: April 2011
• Est. completion date: June 2019

Study information

• Verified date: April 2016
• Source: University of Ulm
• Contact: Manuel B Schmid, Dr. med.
• Phone: +49 731 500
• Email: manuel.schmid[@]uniklinik-ulm.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Very low birthweight infants

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Birth Weight
• Infant, Very Low Birth Weight

Locations

Country	Name	City	State
Germany	University Medical Center	Ulm	Baden-Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral tissue oxygen saturation during first 72 hours of life		during first 72 hours of life	No