Using Theophylline to Prevent Kidney Damage in Newborns with Hypoxic Ischemic Encephalopathy
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
PHASE1; PHASE2 · Medical College of Wisconsin · NCT05853601
This study is testing if giving theophylline to newborns with brain injury can help prevent kidney damage when they are treated with cooling therapy.
Quick facts
| Phase | PHASE1; PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 1 Hour to 18 Hours |
| Sex | All |
| Sponsor | Medical College of Wisconsin (other) |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05853601 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the use of theophylline, administered shortly after birth, to prevent acute kidney injury (AKI) in infants diagnosed with hypoxic ischemic encephalopathy (HIE). The study aims to evaluate the feasibility of this intervention in infants treated with therapeutic hypothermia, which is the current standard of care for HIE. By assessing recruitment, protocol adherence, and data collection procedures, the study seeks to lay the groundwork for a larger clinical trial that will explore the long-term effects of theophylline on kidney health in at-risk infants. The ultimate goal is to reduce the incidence and severity of AKI and improve renal outcomes over a two-year period.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at or after 35 weeks gestation, weighing more than 1800 grams, and diagnosed with HIE who can receive hypothermia treatment within six hours of birth.
Not a fit: Patients with significant renal, urinary tract, brain, heart, or lung abnormalities, or those unable to initiate hypothermia within the required timeframe, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce kidney injury and improve survival rates in newborns affected by HIE.
How similar studies have performed: Previous small trials have suggested that theophylline may help prevent AKI in infants with HIE, but this specific approach in the context of therapeutic hypothermia is novel.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey Segar, MD — Medical College of Wisconsin
- Study coordinator: Jeffrey Segar, MD
- Email: jsegar@mcw.edu
- Phone: 414-955-8296
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Kidney Injury, HIE