Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

• Sponsor: University of New Mexico (Other)
• Overall Status: Completed
• CT.gov ID: NCT01235923
• Collaborator: National Center for Research Resources (NCRR) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 2
• Duration (Months): 44
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Infants	Drug: three times weekly Epo; Drug: weekly Epo	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: three times weekly Epo Epo 400 units/kg three times weekly given subcutaneously for 4 weeks	Drug: three times weekly Epo; Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks; Other Names: Epoetin alfa Procrit
Active Comparator: weekly Epo 1,200 units/kg given once a week subcutaneously for 4 weeks	Drug: weekly Epo; Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks; Other Names: Epoetin alfa Procrit

Outcome Measures

Primary Outcome Measures

1. Baseline Retic Count [baseline]

   retic count measured at study entry

2. Reticulocyte Count [4 weeks]

   reticulocyte count at 4 weeks (end of study)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Days to 100 Days
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNM NICU	Albuquerque	New Mexico	United States	87131

Sponsors and Collaborators

• University of New Mexico
• National Center for Research Resources (NCRR)

Investigators

• Principal Investigator: Robin K Ohls, MD, University of New Mexico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of New Mexico
• ClinicalTrials.gov Identifier: NCT01235923
• Other Study ID Numbers: 05-380; M01RR000997
• First Posted: Nov 8, 2010
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2012

• Keywords provided by University of New Mexico: anemia; transfusions; erythropoiesis; neonate; preterm
• Additional relevant MeSH terms: Premature Birth; Epoetin Alfa

Study Results

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.

Arm/Group Title	Three Times Weekly Epo	Weekly Epo
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

Baseline Characteristics

Arm/Group Title	Three Times Weekly Epo	Weekly Epo	Total
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 Participants	10	10	20
Age, Customized (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	15 (4)	18 (3)	17 (3)
Sex: Female, Male (Count of Participants)
Female	6 60%	5 50%	11 55%
Male	4 40%	5 50%	9 45%

Outcome Measures

1. Primary Outcome

Title	Baseline Retic Count
Description	retic count measured at study entry
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

All study subjects had baseline retic count measured.

Arm/Group Title	Weekly Epo	Three Times a Week Epo
Arm/Group Description
Measure Participants	10	10
Mean (Standard Error) [x1000 cells/microliter]	122 (12)	140 (24)

2. Primary Outcome

Title	Reticulocyte Count
Description	reticulocyte count at 4 weeks (end of study)
Time Frame	4 weeks

Outcome Measure Data

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
Arm/Group Description
Measure Participants	10	10
Mean (Standard Error) [cells x 1000/microliter]	275 (70)	268 (34)

Adverse Events

Arm/Group Title	Weekly Epo		Three Times Weekly Epo
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Weekly Epo		Three Times Weekly Epo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/10 (10%)		1/10 (10%)
Gastrointestinal disorders
Death	1/10 (10%)	1	1/10 (10%)	1
Other (Not Including Serious) Adverse Events
	Weekly Epo		Three Times Weekly Epo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/10 (50%)		6/10 (60%)
Nervous system disorders
interventricular hemorrhage greater than grade 2	1/10 (10%)	1	3/10 (30%)	3
Respiratory, thoracic and mediastinal disorders
bronchopulmonary dysplasia	5/10 (50%)	5	6/10 (60%)	6

Limitations/Caveats

pilot study with only 20 infants evaluated

More Information

Certain Agreements

All Principal Investigators ARE 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.