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Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Sponsor: Medical College of Wisconsin
Summary
Acute kidney injury is a significant complication for infants who experience hypoxic ischemic encephalopathy, being associated with increased rates of death and prolonged hospitalization. This pilot study of theophylline administration soon after birth for the prevention of kidney injury will lay the foundation for the conduct of a larger clinical trial that seeks to identify a theophylline as a novel therapy to prevent kidney injury in thousands of at-risk infants.
Key Details
Gender
All
Age Range
1 Hour - 18 Hours
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-10-17
Completion Date
2027-04-01
Last Updated
2025-09-18
Healthy Volunteers
No
Conditions
Interventions
Single Dose Theophylline
Subjects are given a single loading dose of theophylline, 5mg/kg IV, within 18 hours after birth. A bioequivalent dose of aminophylline, a more soluble, ethylenediamine salt of theophylline, may be substituted for theophylline. The bioequivalent dose of aminophylline is 120% of the theophylline dose.
Repeat Dose Theophylline
Subjects are given a loading dose of theophylline, 5mg/kg IV, within 18 hours of birth, and then two subsequent doses (1.2mg/kg iv) at 12 hours and 24 hours after loading dose. A bioequivalent dose of aminophylline, a more soluble, ethylenediamine salt of theophylline, may be substituted for theophylline. The bioequivalent dose of aminophylline is 120% of the theophylline dose.
Locations (1)
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States