Preterm Erythropoietin Neuroprotection Trial (PENUT Trial)
Public ClinicalTrials.gov record NCT01378273. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 markers of brain injury, will be safe, and will confer improved neurodevelopmental outcome at 24-26 months corrected age compared to placebo, and will provide a much-needed therapy for this group of vulnerable infants.
Study identification
- NCT ID
- NCT01378273
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 941 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 24 Weeks to 27 Weeks
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2013
- Primary completion
- Feb 27, 2019
- Completion
- Feb 27, 2020
- Last update posted
- May 18, 2026
2013 – 2020
United States locations
- U.S. sites
- 19
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arkansas | Little Rock | Arkansas | 72202 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| South Miami Hospital | Miami | Florida | 33146 | — |
| Florida Hospital | Orlando | Florida | 32804 | — |
| All Childrens Hospital | St. Petersburg | Florida | 33701 | — |
| Prentice Women's Hospital | Chicago | Illinois | 60611 | — |
| Children's Hospital of the University of Illinois | Chicago | Illinois | 60612 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Johns Hopkins | Baltimore | Maryland | 21224 | — |
| Beth Israel Deaconess Hospital | Boston | Massachusetts | 02215 | — |
| Children's Hospital of Minnesota, MN | Minneapolis | Minnesota | 55404 | — |
| University of Minnesota Amplatz Children's Hospital | Minneapolis | Minnesota | 55455 | — |
| Children's Hospital of Minnesota, St. Paul | Saint Paul | Minnesota | 55102 | — |
| University of New Mexico Children's Hospital | Albuquerque | New Mexico | 87131 | — |
| Maia Fareri Children's Hospital | Valhalla | New York | 10595 | — |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Methodist Children's Hospital | San Antonio | Texas | 78229 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| University of Washington | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01378273, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 18, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01378273 live on ClinicalTrials.gov.