Actively Recruiting
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Led by Medical College of Wisconsin · Updated on 2026-04-13
30
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
M
Medical College of Wisconsin
Lead Sponsor
U
University of Oklahoma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Gestational age at birth equal to or greater than 35 weeks by best obstetrical dating
- Birth weight greater than 1800 grams
- Clinical diagnosis of hypoxic-ischemic encephalopathy and initiation of therapeutic hypothermia within six hours of birth according to institutional guidelines
- No known congenital abnormalities involving the brain, kidneys, heart, or lungs
- Ability to administer theophylline intravenously within 18 hours of birth
You will not qualify if you...
- Infants with suspected or diagnosed significant abnormalities of the kidneys, urinary tract, brain, heart, or lungs
- Known chromosomal anomalies
- Evidence of head trauma or skull fracture causing major intracranial hemorrhage
- Inability to start hypothermia treatment within six hours of birth
- Attending physician unwilling to allow infant participation
- Inability to obtain informed consent within 18 hours of birth
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
Research Team
J
Jeffrey Segar, MD
CONTACT
E
Elizabeth Awe, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here