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

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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