Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

Preterm Infants Clinical Trial

Official title:

A Randomized, Masked Study of Weekly Erythropoietin Dosing in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235923
• Other study ID #: 05-380
• Secondary ID: M01RR000997
• Status: Completed
• Phase: Phase 2
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Days

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infants

Intervention

Drug:
• three times weekly Epo
Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
• weekly Epo
Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Locations

Country	Name	City	State
United States	UNM NICU	Albuquerque	New Mexico

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Retic Count	retic count measured at study entry	baseline
Primary	Reticulocyte Count	reticulocyte count at 4 weeks (end of study)	4 weeks