Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Collaborator: University of Oklahoma
• Treatments: Theophylline

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