Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Medical College of Wisconsin
30 participants
Oct 17, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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 Criteria6
- infants with suspected or diagnosed significant renal, urinary tract, brain, heart, or lung abnormalities
- infant with known chromosomal anomaly
- evidence of head trauma or skull fracture causing major intracranial hemorrhage
- inability to initiate hypothermia within six hours of birth
- attending physician unwilling to have infant participate in the study
- inability to obtain informed consent within 18 hours of birth
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Interventions
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.
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)
View Full Details on ClinicalTrials.gov
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NCT05853601