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RECRUITING Phase 1

Theophylline Prophylaxis During Hypothermia to Limit Neonatal Nephron Damage

NCT05853601 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 30 participants
Start Date 2023-10-17
Est. Completion 2027-04-01
Phase Phase 1

Sponsor

Medical College of Wisconsin

614 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05853601

The ClinicalTrials.gov registry entry for NCT05853601 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05853601 reports 1 study location spanning 1 distinct geographic area — top geographies include Oklahoma. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05853601?

The interventions under investigation include: Single Dose Theophylline (DRUG), Repeat Dose Theophylline (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05853601?

This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial