Trial Outcomes & Findings for Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants (NCT NCT01235923)

Results Overview

retic count measured at study entry

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

baseline

Results posted on

2022-06-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Three Times Weekly Epo Epo 400 units/kg three times weekly given subcutaneously for 4 weeks	Weekly Epo Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
Overall Study STARTED	10	10
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Three Times Weekly Epo n=10 Participants Epo 400 units/kg three times weekly given subcutaneously for 4 weeks	Weekly Epo n=10 Participants Epo 1,200 units/kg given once a week subcutaneously for 4 weeks	Total n=20 Participants Total of all reporting groups
Age, Customized	15 days STANDARD_DEVIATION 4 • n=5 Participants	18 days STANDARD_DEVIATION 3 • n=7 Participants	17 days STANDARD_DEVIATION 3 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

Population: All study subjects had baseline retic count measured.

retic count measured at study entry

Outcome measures

Outcome measures
Measure	Weekly Epo n=10 Participants	Three Times a Week Epo n=10 Participants
Baseline Retic Count	122 x1000 cells/microliter Standard Error 12	140 x1000 cells/microliter Standard Error 24

PRIMARY outcome

Timeframe: 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.

reticulocyte count at 4 weeks (end of study)

Outcome measures

Outcome measures
Measure	Weekly Epo n=10 Participants	Three Times a Week Epo n=10 Participants
Reticulocyte Count	275 cells x 1000/microliter Standard Error 70	268 cells x 1000/microliter Standard Error 34

Adverse Events

Weekly Epo

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Three Times Weekly Epo

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Weekly Epo n=10 participants at risk Epo 1,200 units/kg given once a week subcutaneously for 4 weeks	Three Times Weekly Epo n=10 participants at risk Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
Gastrointestinal disorders Death	10.0% 1/10 • Number of events 1	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	Weekly Epo n=10 participants at risk Epo 1,200 units/kg given once a week subcutaneously for 4 weeks	Three Times Weekly Epo n=10 participants at risk Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
Respiratory, thoracic and mediastinal disorders bronchopulmonary dysplasia	50.0% 5/10 • Number of events 5	60.0% 6/10 • Number of events 6
Nervous system disorders interventricular hemorrhage greater than grade 2	10.0% 1/10 • Number of events 1	30.0% 3/10 • Number of events 3

Additional Information

Robin Ohls

University of Utah

Phone: 801-581-7052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place