Brain, Gut and Kidney Blood Flow During Medical Closure of PDA
Information source: University of Louisville
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Patent Ductus Arteriosus
Intervention: INVOS Cerebral/Somatic oximeter (Device)
Phase: N/A
Status: Recruiting
Sponsored by: University of Louisville Official(s) and/or principal investigator(s):
Dan L Stewart, MD, Principal Investigator, Affiliation: University of Louisville
Overall contact:
Dan L Stewart, MD, Phone: 502 852 8470, Email: dlstew01@louisville.edu
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.
Clinical Details
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 design: Cohort, Prospective
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.Measure oxygenation/blood flow to brain during PDA treatment
Secondary outcome: Oxygenation during/after treatment with PDA therapy
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Dan L Stewart, MD, Phone: 502 852 8470, Email: dlstew01@louisville.edu
Kosair Children's Hospital, Lousiville, Kentucky 40202, United States; Recruiting
Dan L Stewart, MD, Principal Investigator
Stephan Pepple, MD, Sub-Investigator
Scott D Duncan, MD, Sub-Investigator
Additional Information
Starting date: November 2007
Ending date: December 2008
Last updated: August 6, 2009
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