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| ID | Type | Description | Link |
|---|---|---|---|
| M01RR000997 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Research Resources (NCRR) | NIH |
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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.
Erythropoietin (Epo) increases and maintains hematocrit using once weekly dosing in adults with anemia due to end stage renal disease. Epo is used in preterm infants to treat the anemia of prematurity, but has not been studied using once weekly dosing. We compared reticulocyte responses of once weekly Epo dosing with thrice weekly dosing in preterm infants.
Infants ≤1,500 grams and ≥7 days of age were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation. Complete blood counts, absolute reticulocyte counts (ARC), transfusions, phlebotomy losses, and adverse events were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| three times weekly Epo | Active Comparator | Epo 400 units/kg three times weekly given subcutaneously for 4 weeks |
|
| weekly Epo | Active Comparator | 1,200 units/kg given once a week subcutaneously for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| three times weekly Epo | Drug | Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Retic Count | retic count measured at study entry | baseline |
| Reticulocyte Count | reticulocyte count at 4 weeks (end of study) | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin K Ohls, MD | University of New Mexico | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM NICU | Albuquerque | New Mexico | 87131 | United States |
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Infants ≤1,500 grams and ≥7 days of age hospitalized in the NICU at UNM between 4/06 and 3/09 were randomized to once weekly Epo, 1,200 units/kg/dose, or thrice weekly Epo, 400 units/kg/dose, subcutaneously for 4 weeks, along with iron and vitamin supplementation.
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| ID | Title | Description |
|---|---|---|
| FG000 | Three Times Weekly Epo | Epo 400 units/kg three times weekly given subcutaneously for 4 weeks |
| FG001 | Weekly Epo | Epo 1,200 units/kg given once a week subcutaneously for 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Three Times Weekly Epo | Epo 400 units/kg three times weekly given subcutaneously for 4 weeks |
| BG001 | Weekly Epo | Epo 1,200 units/kg given once a week subcutaneously for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Baseline Retic Count | retic count measured at study entry | All study subjects had baseline retic count measured. | Posted | Mean | Standard Error | x1000 cells/microliter | baseline |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Weekly Epo | Epo 1,200 units/kg given once a week subcutaneously for 4 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bronchopulmonary dysplasia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | oxygen requirement at 36 weeks adjusted age |
pilot study with only 20 infants evaluated
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robin Ohls | University of Utah | 801-581-7052 | robin.ohls@hsc.utah.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| weekly Epo | Drug | Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks |
|
|
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | Reticulocyte Count | reticulocyte count at 4 weeks (end of study) | Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power. | Posted | Mean | Standard Error | cells x 1000/microliter | 4 weeks |
|
|
|
| 1 |
| 10 |
| 5 |
| 10 |
| EG001 | Three Times Weekly Epo | Epo 400 units/kg three times weekly given subcutaneously for 4 weeks | 1 | 10 | 6 | 10 |
|
| interventricular hemorrhage greater than grade 2 | Nervous system disorders | Systematic Assessment |
|
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| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |