Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage (TheoPHyLNNe)
Acute Kidney Injury, HIE
About this trial
This is an interventional prevention trial for Acute Kidney Injury
Eligibility Criteria
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 12 hours of birth Exclusion Criteria: 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 12 hours of birth
Sites / Locations
- University of Oklahoma Health Sciences CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Single Dose Theophylline
Repeat Dose Theophylline
Standard treatment
Single dose of theophylline or aminophylline (5mg/kg IV) given within 12 hours after birth
Loading dose of theophylline or aminophylline (5mg/kg IV) given within 12 hours of birth, with two subsequent doses (1.2 mg/kg IV) given at12 and 24 hours after the loading dose
Infants cared for according to standard practice.