Brief Title
Influence of Treatment for Patent Ductus Arteriosus on Cerebral Oxygenation in Preterm Infants
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 Description
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.
Study Type
Observational
Primary Outcome
Change of cerebral tissue oxygen saturation during treatment for patent ductus arteriosus
Condition
Prematurity of Fetus
Intervention
Indomethacin
Study Arms / Comparison Groups
Indomethacin
Description: Infants treated with Indomethacin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
35
Start Date
April 2011
Completion Date
March 2016
Primary Completion Date
October 2012
Eligibility Criteria
Inclusion Criteria: - Newborn infant below 34 weeks postmenstrual age at the time of birth - Patent ductus arteriosus with signs of hemodynamic relevance (as judged by the attending neonatologist) - parental informed consent Exclusion Criteria: - Patent ductus arteriosus as part of malformation syndrome - Additional major cardiovascular malformations
Gender
All
Ages
N/A - 34 Weeks
Accepts Healthy Volunteers
No
Contacts
Manuel B Schmid, Dr. med., ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT01428180
Organization ID
ULMNEONIRS03
Responsible Party
Principal Investigator
Study Sponsor
University of Ulm
Study Sponsor
Manuel B Schmid, Dr. med., Principal Investigator, University of Ulm
Verification Date
April 2016