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NCT01378273 · ClinicalTrials.gov registry record · Phase 3
Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
A Phase 3 study, sponsored by University of Washington.
- Completed
- Registry status
- Phase 3
- Development phase
- 941
- Enrollment target
NCT01378273 is a Phase 3 study that has completed, run by University of Washington. The registered enrollment target is 941 participants.
The verdict
NCT01378273, a Phase 3 study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 941 participants
- Enrollment target
Study Summary
Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo decreases neuronal programmed cell death resulting from brain injury; it has anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from injury. We hypothesize that neonatal Epo treatment of ELGANs will decrease the combined outcome of death or severe NDI from 40% to 30% (primary outcome), or the combined outcome of death plus moderate or severe NDI from 60% to 40% (secondary outcome) measured at 24-26 months corrected age. 1. To determine whether Epo decreases the combined outcome of death or NDI at 24-26 months corrected age. NDI is defined as the presence of any one of the following: CP, Bayley Scales of Infant and Toddler Development, 3rd Edition (Bayley-III) Cognitive Scale \< 70 (severe, 2 SD below mean) or 85 (moderate, 1 SD below mean). CP will be diagnosed and classified by standardized neurologic exam, with severity classified by Gross Motor Function Classification System (GMFCS). 2. To determine whether there are risks to Epo administration in ELGANs by examining, in a blinded manner, Epo-related safety measures comparing infants receiving Epo with those given placebo. 3. To test whether Epo treatment decreases serial measures of circulating inflammatory mediators, and biomarkers of brain injury. 4. To compare brain structure (as measured by MRI) in Epo treatment and control groups at 36 weeks PMA. MRI assessments will include documentation of intraventricular hemorrhage (IVH), white matter injury (WMI) and hydrocephalus (HC), volume of total and deep gray matter, white matter and cerebellum, brain gyrification, and tract-based spatial statistics (TBSS based on diffusion tensor imaging). As an exploratory aim, we will determine which of the above MRI measurements best predict neurodevelopment (CP, cognitive and motor scales) at 24-26 months corrected age. Anticipated outcomes: Early Epo treatment of ELGANs will decrease biochemical and MRI m
Interventions
- OTHER Control
- DRUG Epo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 941 participants |
| Start Date | 2013-12 |
| Est. Completion | 2020-02-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01378273
The ClinicalTrials.gov registry entry for NCT01378273 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 941 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT01378273 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01378273 about?
NCT01378273 is a clinical study titled "Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)". Recombinant human erythropoietin (Epo) is a promising novel neuroprotective agent. Epo decreases neuronal programmed cell death resulting from brain injury; it has anti-inflammatory effects, increases neurogenesis, and protects oligodendrocytes from injury. We hypothesize that neonatal Epo treatmen...
What is the current status of trial NCT01378273?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 941 participants. The study started on 2013-12. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT01378273?
The interventions under investigation include: Control (OTHER), Epo (DRUG).
Who is sponsoring clinical trial NCT01378273?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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