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Completed

NCT Number: NCT01235923

Randomized Study of Weekly Erythropoietin Dosing in Preterm Infants

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.

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Key information

Conditions

Preterm Infants Anemia Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

7 day–100 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UNM NICU

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

three times weekly Epo

Drug

Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks

Other names: Epoetin alfa, Procrit

weekly Epo

Drug

Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks

Other names: Epoetin alfa, Procrit

Primary outcomes

  1. Baseline Retic Count

    Time frame: baseline

    retic count measured at study entry

  2. Reticulocyte Count

    Time frame: 4 weeks

    reticulocyte count at 4 weeks (end of study)

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Center for Research Resources (NCRR)

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 8, 2010
Registry last updated
Jun 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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