Clinical Trial: Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates

Brief Summary: The purpose of this study is to examine the influence medical or surgical treatment for patent ductus arteriosus in preterm infants on cerebral and renal tissue oxygenation and on cardiac output.

Detailed Summary:

In this observational trial the investigators want to examine whether clinical or echocardiographic parameters of patent ductus arteriosus are related to

  • cerebral tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD
  • renal tissue oxygen saturation, total hemoglobin, fractional tissue oxygen extraction and HbD

as measured by near infrared spectroscopy

and to

  • stroke volume
  • cardiac output

as measured by electrical cardiometry.

The investigators want to examine the impact of surgical and medical treatment for patent ductus on these parameters. The investigators want to compare the change of these parameters between responders to medical treatment and nonresponders.


Sponsor: University of Ulm

Current Primary Outcome: Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus [ Time Frame: from 10 minutes before start of infusion until 4 hours after end of transfusion ]

Original Primary Outcome: Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Ulm

Dates:
Date Received: August 31, 2011
Date Started: April 2011
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016