Phase 2
N=20
Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
Preterm Infants
Bottom Line
View on ClinicalTrials.gov: NCT01235923 ↗Enrolled (actual)
20
Serious AEs
10.0%
Results posted
Jul 2013
Primary outcome: Primary: Baseline Retic Count — 122; 140 x1000 cells/microliter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- three times weekly Epo (Drug); weekly Epo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of New Mexico
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Retic Count |
122; 140 | — |
| PRIMARY Reticulocyte Count |
275; 268 | — |
Summary
Preterm infants are a risk for multiple transfusions, and the administration of human recombinant erythropoietin (Epo) has been shown to decrease transfusion requirements. Dosing usually occurs three times a week, but extended dosing schedules have been successful in adults. The investigators assessed weekly Epo dosing in preterm infants compared to standard three times weekly dosing.
Eligibility Criteria
Inclusion Criteria
- or = 7 days of age
- informed consent obtained
Exclusion Criteria
- hemolytic disease
- hypertension
- seizures
- thromboses
- major malformation
Data sourced from ClinicalTrials.gov (NCT01235923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.