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Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

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ClinicalTrials.gov Identifier: NCT01235923
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : July 29, 2013
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
University of New Mexico

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Preterm Infants
Interventions Drug: three times weekly Epo
Drug: weekly Epo
Enrollment 20
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.
Pre-assignment Details  
Arm/Group Title Three Times Weekly Epo Weekly Epo
Hide Arm/Group Description Epo 400 units/kg three times weekly given subcutaneously for 4 weeks Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
Period Title: Overall Study
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Three Times Weekly Epo Weekly Epo Total
Hide Arm/Group Description Epo 400 units/kg three times weekly given subcutaneously for 4 weeks Epo 1,200 units/kg given once a week subcutaneously for 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 10 participants 10 participants 20 participants
15  (4) 18  (3) 17  (3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
6
  60.0%
5
  50.0%
11
  55.0%
Male
4
  40.0%
5
  50.0%
9
  45.0%
1.Primary Outcome
Title Baseline Retic Count
Hide Description retic count measured at study entry
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
All study subjects had baseline retic count measured.
Arm/Group Title Weekly Epo Three Times a Week Epo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: x1000 cells/microliter
122  (12) 140  (24)
2.Primary Outcome
Title Reticulocyte Count
Hide Description reticulocyte count at 4 weeks (end of study)
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Power analysis based on difference in mean retic count (baseline versus 4 weeks) of 75 (standard deviation 50), alpha 0.05, 80% power.
Arm/Group Title Weekly Epo Three Times a Week Epo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 10 10
Mean (Standard Error)
Unit of Measure: cells x 1000/microliter
275  (70) 268  (34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Weekly Epo Three Times Weekly Epo
Hide Arm/Group Description Epo 1,200 units/kg given once a week subcutaneously for 4 weeks Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
All-Cause Mortality
Weekly Epo Three Times Weekly Epo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Weekly Epo Three Times Weekly Epo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/10 (10.00%)      1/10 (10.00%)    
Gastrointestinal disorders     
Death   1/10 (10.00%)  1 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Weekly Epo Three Times Weekly Epo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/10 (50.00%)      6/10 (60.00%)    
Nervous system disorders     
interventricular hemorrhage greater than grade 2   1/10 (10.00%)  1 3/10 (30.00%)  3
Respiratory, thoracic and mediastinal disorders     
bronchopulmonary dysplasia  [1]  5/10 (50.00%)  5 6/10 (60.00%)  6
Indicates events were collected by systematic assessment
[1]
oxygen requirement at 36 weeks adjusted age
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robin Ohls
Organization: University of Utah
Phone: 801-581-7052
EMail: robin.ohls@hsc.utah.edu
Layout table for additonal information
Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01235923    
Other Study ID Numbers: 05-380
M01RR000997 ( U.S. NIH Grant/Contract )
First Submitted: November 4, 2010
First Posted: November 8, 2010
Results First Submitted: November 29, 2012
Results First Posted: July 29, 2013
Last Update Posted: June 21, 2022