Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
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.
Description
Acute kidney injury (AKI) is commonly seen in infants diagnosed with hypoxic-ischemic encephalopathy (HIE) and is associated with increased rates of morbidity and mortality. Currently, there are no approved therapies that target the prevention of AKI. Several small trials in infants with HIE suggest that a single dose of theophylline given soon after birth attenuates the development of AKI. However, these studies were not performed in infants being treated with therapeutic hypothermia (the current standard of care for moderate to severe HIE), and only reported short-term outcomes. Therefore, f…
Eligibility
- Age range
- 1–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * gestational age at birth \>= 35 weeks by best obstetrical dating * birth weight \> 1800 grams * clinical determination of HIE and treatment with hypothermia being initiated within six hours of birth according to institutional guidelines * no known congenital abnormalities involving the brain, kidneys, heart or lungs * ability to administer theophylline via intravenous route within 18 hours of birth Exclusion Criteria: * infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities * infant with known chromosomal anomaly * evi…
Interventions
- DrugSingle 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.
- DrugRepeat 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.
Location
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma