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NCT05853601 · ClinicalTrials.gov registry record · Phase 1
Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage
A Phase 1 study of Acute Kidney Injury and HIE, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05853601: Recruiting Phase 1 study of Acute Kidney Injury and HIE, sponsored by Medical College of Wisconsin.
NCT05853601 is a Phase 1 study of Acute Kidney Injury and HIE that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 30 participants, below the 2,331-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05853601, a Phase 1 study of Acute Kidney Injury and HIE, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Examine the ability to recruit and enroll patients in trial. We will assess the number of eligible patients and compare that number to those actually enrolled. This ratio will inform regarding the ability to recruit patients in a larger, randomized, appropriately powered trial.
Conditions Studied
Interventions
- DRUG Single Dose Theophylline
- DRUG Repeat Dose Theophylline
Study Locations (1)
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 1 |
What NCT05853601 shows while recruiting
NCT05853601 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 2,331-participant average among 74 other Acute Kidney Injury trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Acute Kidney Injury appearing as the primary indexed condition, and to 2 interventions - of which Single Dose Theophylline is the first listed.
NCT05853601 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT05853601 about?
NCT05853601 is a clinical study titled "Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage". 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 th...
What is the current status of trial NCT05853601?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-10-17. Estimated completion is 2027-04-01.
What conditions does trial NCT05853601 study?
This clinical trial studies the following conditions: Acute Kidney Injury, HIE.
What interventions are being tested in trial NCT05853601?
The interventions under investigation include: Single Dose Theophylline (DRUG), Repeat Dose Theophylline (DRUG).
Who is sponsoring clinical trial NCT05853601?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05853601 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Kidney Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05853601's enrollment target sits among peer trials
30 65th of 74 higher than 9 of 74 other Acute Kidney Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Kidney Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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