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Methylxanthine
Theophylline for Hypoxic-Ischemic Encephalopathy (TheoPHyLNNe Trial)
Phase 1 & 2
Recruiting
Led By Jeffrey Segar, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No known congenital abnormalities involving the brain, kidneys, heart or lungs
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
TheoPHyLNNe Trial Summary
This trial tests theophylline to prevent kidney injury in infants at risk of hypoxic ischemic encephalopathy. If successful, it could help thousands of infants.
Who is the study for?
This trial is for newborns born at or after 35 weeks of gestation, weighing over 1800 grams, who can receive theophylline within 12 hours of birth and are starting hypothermia treatment for HIE within six hours. Infants with major organ abnormalities or those whose doctors don't agree to participate are excluded.Check my eligibility
What is being tested?
The study tests whether giving theophylline soon after birth can prevent kidney damage in infants with hypoxic ischemic encephalopathy undergoing hypothermia treatment. It compares repeated doses versus a single dose to lay groundwork for future larger trials.See study design
What are the potential side effects?
Potential side effects from theophylline may include irritability, jitteriness, increased heart rate, digestive issues like reflux or diarrhea, and rarely seizures. These effects depend on dosage and individual infant response.
TheoPHyLNNe Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I don't have any birth defects in my brain, kidneys, heart, or lungs.
TheoPHyLNNe Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment of patients
Secondary outcome measures
Acute kidney injury#1
Acute kidney injury#2
Demonstration of successful adherence to study protocol
+7 moreTheoPHyLNNe Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Single Dose TheophyllineExperimental Treatment1 Intervention
Single dose of theophylline or aminophylline (5mg/kg IV) given within 12 hours after birth
Group II: Repeat Dose TheophyllineExperimental Treatment1 Intervention
Loading dose of theophylline or aminophylline (5mg/kg IV) given within 12 hours of birth, with two subsequent doses (1.2 mg/kg IV) given at12 and 24 hours after the loading dose
Group III: Standard treatmentActive Control1 Intervention
Infants cared for according to standard practice.
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
610 Previous Clinical Trials
1,162,659 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
21 Patients Enrolled for Acute Kidney Injury
University of OklahomaOTHER
455 Previous Clinical Trials
95,869 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
33 Patients Enrolled for Acute Kidney Injury
Jeffrey Segar, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
31 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
1 Patients Enrolled for Acute Kidney Injury
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I was unable to give consent within 12 hours of birth.My baby started cooling treatment within 6 hours of birth for brain injury.The baby was born at 35 weeks of pregnancy or later based on the best estimate of the due date.My infant has a significant condition affecting the kidneys, urinary tract, brain, heart, or lungs.I can receive theophylline intravenously within 12 hours of birth.You weighed more than 1800 grams at birth.My infant has a diagnosed chromosomal anomaly.I was not cooled within six hours after being born.I have had a head injury that caused significant bleeding in my brain.I don't have any birth defects in my brain, kidneys, heart, or lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Single Dose Theophylline
- Group 2: Repeat Dose Theophylline
- Group 3: Standard treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who qualifies for inclusion in this clinical experiment?
"The medical trial seeks to enrol 54 patients with acute kidney injury, aged between 60 minutes and 12 hours."
Answered by AI
Is access to this research study available for members of the public?
"Based on the details found on clinicaltrials.gov, this particular medical trial has ceased recruitment for participants. The experiment was initially posted in June 1st 2023 and last updated May 2nd 2023. However, there are 166 other studies that presently welcome volunteers to join their research efforts."
Answered by AI
Is this research program enrolling geriatric individuals?
"To be eligible for this clinical trial, patients must fall between 1 Hour and 12 Hours of age. Additionally, 18 medical trials are available to individuals below the legal consenting age while 146 studies can be accessed by those over 65 years old."
Answered by AI
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