Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of New Mexico
ClinicalTrials.gov Identifier:
NCT01235923
First received: November 4, 2010
Last updated: June 19, 2013
Last verified: June 2012
Results First Received: November 29, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Preterm Infants
Interventions: Drug: three times weekly Epo
Drug: weekly Epo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
none

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Three Times Weekly Epo     Weekly Epo  
STARTED     10     10  
COMPLETED     10     10  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
    Three Times Weekly Epo     Weekly Epo     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age, Customized  
[units: days]
Mean ± Standard Deviation
  15  ± 4     18  ± 3     17  ± 3  
Gender  
[units: participants]
     
Female     6     5     11  
Male     4     5     9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Baseline Retic Count   [ Time Frame: baseline ]

2.  Primary:   Reticulocyte Count   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
pilot study with only 20 infants evaluated


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robin Ohls
Organization: University of New Mexico
phone: 505-272-6410
e-mail: rohls@salud.unm.edu


No publications provided


Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT01235923     History of Changes
Other Study ID Numbers: 05-380, M01RR000997
Study First Received: November 4, 2010
Results First Received: November 29, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board