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Study details
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Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

Medical College of Wisconsin
NCT IDNCT05853601ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

30

Study length

about 3.5 years

Ages

0.000114079458624521–0.00205343025524138

Locations

1 site in OK

What this study is about

This trial is testing whether giving theophylline, a medication, to newborns who have experienced brain injury and are being cooled down can help prevent kidney damage. The goal of this pilot trial is to lay the groundwork for future studies that could potentially use theophylline to protect kidneys in many more infants at risk.

Simplified from trial records by PatientMatch.

What you may be asked to do

  • 1.Take Repeat Dose Theophylline
  • 2.Take Single Dose Theophylline

Participation Burden

What's physically and logistically required of participants.

Logistics & Travel
In-person visits

Requires travel to a study site

Physical Intervention
Oral

How treatment is administered

Treatment Assignment
Randomized & Blinded

You may get a placebo/standard care, and you won't know which.

Extracted study details

Pulled from the trial record to show what is being tested and what the study is measuring.

Drug classes

bronchodilator (Methylxanthine; relaxes airway smooth muscle (PDE inhibition)

Drug routes

oral (Extended Release Oral Capsule)

Endpoints

Secondary: Pharmacokinetic Profile of Theophylline#1, Pharmacokinetic Profile of Theophylline#2

Body systems

Renal