Could a common asthma drug shield newborns from kidney damage?
NCT ID NCT05853601
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests whether the drug theophylline can prevent kidney injury in newborns who experienced oxygen deprivation at birth (HIE) and are receiving cooling therapy. Thirty infants will receive one or two doses of theophylline within 18 hours of birth. The main goal is to see if a larger trial is possible, not yet to prove the drug works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- theophylline (a drug similar to caffeine, given intravenously)
- What this could lead to
- If this works, it could point toward a way to prevent kidney injury in thousands of at-risk newborns with HIE.
- What could go wrong
- This is a very early, small pilot study with only 30 infants. It is designed mainly to test feasibility and safety, not to prove the drug works. Theophylline can cause side effects like rapid heart rate.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2023
- Expected to finish
-
May 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
1 hour to 18 hours
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute kidney injury are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Common Anti-Nausea drugs under scrutiny for kidney risk during chemo
- Heart attack delay may signal kidney risk after angioplasty
- ICU kidney injury: does the pattern predict lasting damage?
- Can a kidney ultrasound scan warn of kidney damage after heart bypass surgery?
- Two blood tests may separate real kidney harm from a false alarm
- Can watching kidney oxygen during liver surgery keep kidneys safe?