Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage (NCT05853601) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
United States30 participantsStarted 2023-10-17
Plain-language 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.
Who can participate
Age range
1 Hour – 18 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.