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

January 22, 2015 updated by: University of Louisville

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lousiville, Kentucky, United States, 40202
        • Kosair Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Preterm infants with patent ductus arteriosus requiring medical intervention

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Indo
Infants that are treated with indomethacin
Device: INVOS Cerebral/Somatic oximeter
Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.
Neo
Infants treated with neoprofen
Device: INVOS Cerebral/Somatic oximeter
Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.
Control
Infants without PDA
Device: INVOS Cerebral/Somatic oximeter
Placement of sensors on back, abdomen and forehead for measurement of perfusion beginning 1 hour prior to initiation of drug, during medical treatment for PDA and for 24 hours after the last dose. For control infants, monitoring will continue for 48 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in blood flow from baseline in infants treated with indomethacin or neoprofen. Blood flow will be measured in the brain, kidney and mesentery.
Time Frame: 48-72 hours
48-72 hours
Measure oxygenation/blood flow to brain during PDA treatment
Time Frame: Study period
Study period

Secondary Outcome Measures

Outcome Measure
Time Frame
Oxygenation during/after treatment with PDA therapy
Time Frame: Study period
Study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

H. Lundbeck A/S

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 2, 2007

First Submitted That Met QC Criteria

November 5, 2007

First Posted (Estimate)

November 6, 2007

Study Record Updates

Last Update Posted (Estimate)

January 26, 2015

Last Update Submitted That Met QC Criteria

January 22, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UofL IRB 328.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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