Preterm Infants
Conditions
Keywords
anemia, transfusions, erythropoiesis, neonate, preterm
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.
Detailed description
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.
Interventions
DRUGthree times weekly Epo
Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
DRUGweekly Epo
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
Sponsors
National Center for Research Resources (NCRR)
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Days to 100 Days
Healthy volunteers
No
Inclusion criteria
* \< or = 1,500 grams * \< or = 32 weeks gestation * \> or = 7 days of age * informed consent obtained
Exclusion criteria
* hemolytic disease * hypertension * seizures * thromboses * major malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Baseline Retic Count | baseline | retic count measured at study entry |
| Reticulocyte Count | 4 weeks | reticulocyte count at 4 weeks (end of study) |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Three Times Weekly Epo Epo 400 units/kg three times weekly given subcutaneously for 4 weeks | 10 |
| Weekly Epo Epo 1,200 units/kg given once a week subcutaneously for 4 weeks | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Three Times Weekly Epo | Weekly Epo | Total |
|---|---|---|---|
| Age, Customized | 15 days STANDARD_DEVIATION 4 | 18 days STANDARD_DEVIATION 3 | 17 days STANDARD_DEVIATION 3 |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 5 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 10 | 6 / 10 |
| serious Total, serious adverse events | 1 / 10 | 1 / 10 |
Outcome results
Primary
Baseline Retic Count
retic count measured at study entry
Time frame: baseline
Population: All study subjects had baseline retic count measured.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly Epo | Baseline Retic Count | 122 x1000 cells/microliter | Standard Error 12 |
| Three Times a Week Epo | Baseline Retic Count | 140 x1000 cells/microliter | Standard Error 24 |
Primary
Reticulocyte Count
reticulocyte count at 4 weeks (end of study)
Time frame: 4 weeks
Population: Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Weekly Epo | Reticulocyte Count | 275 cells x 1000/microliter | Standard Error 70 |
| Three Times a Week Epo | Reticulocyte Count | 268 cells x 1000/microliter | Standard Error 34 |