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

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ClinicalTrials.gov Identifier: NCT00554307
Recruitment Status : Withdrawn (Not able to enroll patients)
First Posted : November 6, 2007
Last Update Posted : January 26, 2015
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by:
University of Louisville

Study Description
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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.

Condition or disease Intervention/treatment
Patent Ductus Arteriosus Device: INVOS Cerebral/Somatic oximeter

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 Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Cerebral, Renal and Mesenteric Perfusion Using Near Infrared Spectroscopy in Neonates During Patent Ductus Arteriosus Closure With Ibuprofen or Indomethacin.
Study Start Date : November 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Measure oxygenation/blood flow to brain during PDA treatment [ Time Frame: Study period ]

Secondary Outcome Measures :
  1. Oxygenation during/after treatment with PDA therapy [ Time Frame: Study period ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants with patent ductus arteriosus requiring medical intervention
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00554307


Locations
United States, Kentucky
Kosair Children's Hospital
Lousiville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
H. Lundbeck A/S
Investigators
Principal Investigator: Dan L Stewart, MD University of Louisville
More Information
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Responsible Party: DStewart, ULouisville
ClinicalTrials.gov Identifier: NCT00554307     History of Changes
Other Study ID Numbers: UofL IRB 328.07
First Posted: November 6, 2007    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by University of Louisville:
patent ductus arteriosus
indomethacin
neoprofen
blood flow

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Indomethacin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action