Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants
A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
2 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 4, 2010
CompletedFirst Posted
Study publicly available on registry
November 8, 2010
CompletedResults Posted
Study results publicly available
July 29, 2013
CompletedJune 21, 2022
June 1, 2012
2.9 years
November 4, 2010
November 29, 2012
May 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Baseline Retic Count
retic count measured at study entry
baseline
Reticulocyte Count
reticulocyte count at 4 weeks (end of study)
4 weeks
Study Arms (2)
three times weekly Epo
ACTIVE COMPARATOREpo 400 units/kg three times weekly given subcutaneously for 4 weeks
weekly Epo
ACTIVE COMPARATOR1,200 units/kg given once a week subcutaneously for 4 weeks
Interventions
Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Eligibility Criteria
You may qualify if:
- \< or = 1,500 grams
- \< or = 32 weeks gestation
- \> or = 7 days of age
- informed consent obtained
You may not qualify if:
- hemolytic disease
- hypertension
- seizures
- thromboses
- major malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UNM NICU
Albuquerque, New Mexico, 87131, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
pilot study with only 20 infants evaluated
Results Point of Contact
- Title
- Robin Ohls
- Organization
- University of Utah
Study Officials
- PRINCIPAL INVESTIGATOR
Robin K Ohls, MD
University of New Mexico
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 4, 2010
First Posted
November 8, 2010
Study Start
April 1, 2006
Primary Completion
March 1, 2009
Study Completion
December 1, 2009
Last Updated
June 21, 2022
Results First Posted
July 29, 2013
Record last verified: 2012-06