Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

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

Brief Title

Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Official Title

Non-Invasive Detection of Tissue Oxygen Deprivation in Premature Infants With Patent Ductus Arteriosus.

Brief Summary

      The proposed research evaluates tissue oxygenation (StO2) as measured by resonance raman
      spectroscopy (RRS) in premature infants with and without patent ductus arteriosus (PDA). This
      is a prospective observational study of infants born at < 30 weeks of gestation. The primary
      aim of this study is to determine if the difference in pre- and post-ductal StO2 as detected
      by RRS is more significant in premature infants with PDA in comparison to infants without
      PDA. The secondary aim of this study is to determine if the difference in pre- and
      post-ductal StO2 as detected by RRS is more significant in infant who develop serious adverse
      events.

Study Type

Observational

Primary Outcome

Differences and pre- and post-ductal RRS measurements of tissue oxygenation.

Secondary Outcome

 Are differences in pre- and post-ductal StO2 as detected by RRS more significant in infants with serious adverse events.

Condition

Premature Infant

Intervention

Resonance Raman Spectroscopy (RRS)

Study Arms / Comparison Groups

 Control Group -Patent Ductus Arteriosus Absent
Description:

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

55

Start Date

May 1, 2015

Completion Date

August 23, 2018

Primary Completion Date

September 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Infants < 30 weeks estimated gestational age

        Exclusion Criteria:

          -  Infants with major congenital anomalies

          -  Infants >34 weeks post-menstrual age

Gender

All

Ages

N/A - N/A

Contacts

J Lauren Ruoss, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03277768

Organization ID

IRB201601508

Responsible Party

Sponsor

Study Sponsor

University of Florida

Collaborators

 Boston Children's Hospital

Study Sponsor

J Lauren Ruoss, MD, Principal Investigator, University of Florida

Verification Date

September 2019