Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

Brief Title

Brain, Gut and Kidney Blood Flow During Medical Closure of PDA

Official Title

Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.

Brief Summary

      The purpose of this study is to determine how the medications which are used to close the
      patent ductus arteriosus (PDA) in preterm infants affect brain, kidney and gut blood flow
      when compared to infants that are not treated with these medications. The medications being
      used for PDA closure are indomethacin and neoprofen.
    

Detailed Description

      All babies requiring medical treatment of their PDA will receive up to 3 doses of medication.
      For babies enrolled in the control group of this study, she/he will not be treated with
      either of these medicines.
    


Study Type

Observational


Primary Outcome

Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.

Secondary Outcome

 Oxygenation during/after treatment with PDA therapy

Condition

Patent Ductus Arteriosus

Intervention

INVOS Cerebral/Somatic oximeter

Study Arms / Comparison Groups

 Indo
Description:  Infants that are 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

Device

Estimated Enrollment

0

Start Date

November 2007

Completion Date

December 2009

Primary Completion Date

December 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Less than or equal to 32 weeks gestation;

          -  Less than or equal to 1250 g;

          -  Mechanical ventilation;

          -  Echocardiographic findings of PDA with left to right shunting;

          -  Medical judgement of neonatologist for medical treatment;

        Exclusion Criteria:

          -  Urine output less than 1 ml/k/hr over previous 12 hours;

          -  Serum creatinine greater than 1.5 mg/dL;

          -  Platelet count less than 100,000 per cubic mm;

          -  Significant skin breakdown at sensor areas;

          -  Significant congenital anomalies

          -  Intraventricular hemorrhage greater than or equal to grade III
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Dan L Stewart, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00554307

Organization ID

UofL IRB 328.07



Study Sponsor

University of Louisville

Collaborators

 H. Lundbeck A/S

Study Sponsor

Dan L Stewart, MD, Principal Investigator, University of Louisville


Verification Date

January 2015