Official Title: “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 Type: Observational

Study Design: Cohort, Prospective

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• : Indo
  • Infants that are treated with indomethacin
• : Neo
  • Infants treated with neoprofen
• : Control
  • Infants without PDA

Primary Measures

• 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
    Safety Issue?: No
• Measure oxygenation/blood flow to brain during PDA treatment
  • Time Frame: Study period
    Safety Issue?: No

Secondary Measures

• Oxygenation during/after treatment with PDA therapy
  • Time Frame: Study period
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Louisville

Overall Clinical Trial Officials and Contacts

Dan L Stewart, MD Principal Investigator University of Louisville  

Overall Contact: Dan L Stewart, MD 502 852 8470 dlstew01@louisville.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00554307

Study ID Number: UofL IRB 328.07

ClinicalTrials.gov Identifier: NCT00554307

Health Authority: United States: Food and Drug Administration