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Darbepoetin Administration to Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00334737
Recruitment Status : Completed
First Posted : June 8, 2006
Results First Posted : February 4, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
Thrasher Research Fund
University of Colorado, Denver
Intermountain Health Care, Inc.
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 Infant, Newborn
Interventions Drug: Darbepoetin Alfa Injection
Drug: erythropoietin alfa injection
Drug: sham injection
Enrollment 102
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Period Title: Hospital Phase
Started 34 34 34
Completed 32 32 30
Not Completed 2 2 4
Reason Not Completed
Death             1             2             3
Withdrawal by Subject             0             0             1
Did not receive study drug             1             0             0
Period Title: Follow up Phase
Started 32 32 30
Completed 27 29 24
Not Completed 5 3 6
Reason Not Completed
Lost to Follow-up             5             3             6
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control Total
Hide Arm/Group Description

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Total of all reporting groups
Overall Number of Baseline Participants 27 29 24 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Months
Number Analyzed 27 participants 29 participants 24 participants 80 participants
20
(20 to 21)
21
(20 to 22)
20
(19.5 to 21)
21
(20 to 22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 24 participants 80 participants
Female
17
  63.0%
10
  34.5%
9
  37.5%
36
  45.0%
Male
10
  37.0%
19
  65.5%
15
  62.5%
44
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 29 participants 24 participants 80 participants
27 29 24 80
gestation  
Median (Inter-Quartile Range)
Unit of measure:  Weeks
Number Analyzed 27 participants 29 participants 24 participants 80 participants
28.3
(26.5 to 29.5)
27.7
(26.2 to 29.1)
28.1
(27.1 to 28.8)
28
(26.5 to 28.9)
birthweight  
Median (Inter-Quartile Range)
Unit of measure:  Grams
Number Analyzed 27 participants 29 participants 24 participants 80 participants
980
(801 to 1090)
930
(778 to 1158)
1005
(810 to 1133)
975
(800 to 1135)
1.Primary Outcome
Title Number of Transfusions During Hospitalization
Hide Description [Not Specified]
Time Frame From birth to 36 weeks gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 33 33 33
Mean (Standard Deviation)
Unit of Measure: number of transfusions
1.2  (2.4) 1.2  (1.6) 2.4  (2.9)
2.Primary Outcome
Title Composite Cognitive Score at 18-22 Months Corrected Age
Hide Description Bayley Scale of Infant Development Composite Cognitive Score. The total composite score is reported, ranging from the lowest score of 55 to the highest score of 145. Lower values specify worse outcome.
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 27 29 24
Mean (Standard Deviation)
Unit of Measure: BSID III compositie cognitive score
96.2  (7.2) 97.9  (14.3) 88.7  (13.5)
3.Secondary Outcome
Title Hematocrit
Hide Description [Not Specified]
Time Frame From birth to 36 weeks gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 32 32 30
Mean (Standard Deviation)
Unit of Measure: L/L
0.35  (0.09) 0.36  (0.08) 0.29  (0.09)
4.Secondary Outcome
Title Reticulocyte Count
Hide Description absolute retic count measured at the end of study
Time Frame at day 60 of study
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 32 32 30
Mean (Standard Error)
Unit of Measure: 1000 cells per microliter
295  (50) 298  (47) 130  (70)
5.Secondary Outcome
Title Volume of Transfusions
Hide Description [Not Specified]
Time Frame From birth to 36 weeks gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 32 32 30
Mean (Standard Deviation)
Unit of Measure: mL/kg
30  (58) 23  (33) 51  (65)
6.Secondary Outcome
Title Epo Concentrations
Hide Description [Not Specified]
Time Frame peak from birth to 36 weeks gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
One hospital participating in the trial lost their samples. The number analyzed only includes those with samples.
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 19 16 20
Mean (Standard Deviation)
Unit of Measure: mU/mL
1398.9  (882.7) 515.4  (280.3) 28.6  (51.1)
7.Secondary Outcome
Title Object Permanence Scores at 18-22 Months
Hide Description Scores are 0-3, with 3 being the best score.
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 27 29 24
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.8  (0.4) 2.4  (0.9) 2.2  (1.0)
8.Secondary Outcome
Title Overall Neurodevelopmental Impairment at 18-22 Months (Visual Impairment, Hearing Impariment, Cerebral Palsy, or Cognitive Score <85/<70 (NDI/Moderate NDI)
Hide Description [Not Specified]
Time Frame 18-22 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 28 30 27
Measure Type: Number
Unit of Measure: participants
4 5 13
9.Secondary Outcome
Title Incidence of Retinopathy of Prematurity Stage 3 or Greater
Hide Description [Not Specified]
Time Frame From birth to 36 weeks gestational age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description:

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

Overall Number of Participants Analyzed 32 32 30
Measure Type: Number
Unit of Measure: participants
2 1 2
Time Frame Initial hospitalization after preterm birth
Adverse Event Reporting Description Adverse events collected during subject's initial hospitalization in the NICU
 
Arm/Group Title Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Hide Arm/Group Description

Darbepoetin 10 mics/kg/week x 10 weeks or until 35 completed weeks

darbepoetin alfa: darbepoetin 10 mics/kg once a week SC for 10 weeks or until 35 completed weeks

Epo 400 units/kg three times a week SC x 10 weeks or until 35 completed weeks

erythropoietin: Epo 400 units/kg 3 x weekly SC for 10 weeks or until 35 completed weeks gestation

Sham injection

sham injection: sham injection

All-Cause Mortality
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/33 (3.03%)      1/33 (3.03%)      3/33 (9.09%)    
General disorders       
death  1 [1]  1/33 (3.03%)  33 1/33 (3.03%)  33 3/33 (9.09%)  33
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
[1]
mortality during initial hospitalization
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Darbepoetin 10 Mics/kg/Week x 10 Weeks or Until 35 Completed w Epo 400 Units/kg Three Times a Week SC x 10 Weeks or Until 35 Placebo/Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/33 (15.15%)      4/33 (12.12%)      9/33 (27.27%)    
Eye disorders       
ROP>stage 2  1  2/33 (6.06%)  2 1/33 (3.03%)  1 2/33 (6.06%)  2
Nervous system disorders       
IVH>grade 2  1  3/33 (9.09%)  3 3/33 (9.09%)  3 7/33 (21.21%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, SNOMED CT
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Robin K Ohls
Organization: University of New Mexico
Phone: 505-272-6753
EMail: rohls@salud.unm.edu
Layout table for additonal information
Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT00334737    
Other Study ID Numbers: 06-139
First Submitted: June 7, 2006
First Posted: June 8, 2006
Results First Submitted: June 7, 2017
Results First Posted: February 4, 2019
Last Update Posted: February 4, 2019