Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants
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.
Prematurity of Fetus
Patent Ductus Arteriosus
Procedure: Surgical Ligation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Changes of Cerebral Tissue Oxygen Saturation During Treatment of Patent Ductus Arteriosus in Neonates|
- Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus [ Designated as safety issue: No ]
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Infants with hemodynamically relevant patent ductus arteriosus||
3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)Procedure: Surgical Ligation
In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
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
- 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.
|Contact: Manuel B Schmid, Dr. med.||+49 731 500 ext email@example.com|
|University Medical Center||Recruiting|
|Ulm, Baden-Württemberg, Germany, 89075|
|Contact: Manuel B Schmid, Dr. med. +49 731 500 ext 57218 firstname.lastname@example.org|
|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: Elvira Stoll|
|Principal Investigator:||Manuel B Schmid, Dr. med.||University of Ulm|