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



Status:Completed
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:Any
Updated:2/7/2015
Start Date:November 2007
End Date:December 2009
Contact:Dan L Stewart, MD
Email:dlstew01@louisville.edu
Phone:502 852 8470

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.

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
We found this trial at
1
site
Kosair Children's Hospital
Lousiville, Kentucky 40202
?
mi
from
Lousiville, KY
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