At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 318 enrolled

Drug / intervention

Erythropoietin +1 moredrug

Likely dose

Erythropoietin 5 mg/kgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01203514

NCT01203514Phase 3Completed

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The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Preterm Infants 401-1250 Grams: Two Multi-Center, Randomized, Double-Masked, Placebo Controlled Studies

NICHD Neonatal Research Network·interventional·Posted Sep 16, 2010·Updated Sep 26, 2017

In Brief

A Phase 3 clinical trial evaluating Erythropoietin and Sham Comparator for Infant, Newborn and 4 related conditions. Completed, enrolled 318 participants across 9 sites.

Detailed Summary

This study tested the safety and efficacy of transfusing erythropoietin (Epo) and iron in infants of \<1,250g birth weight. For infants 401-1,000g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the number of transfusions received. For infants 1,001-1,250g birth weight, we tested whether early erythropoietin (Epo) and iron therapy would decrease the percentage of infants who received any transfusions.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Anemia, Neonatal

CountriesUnited States

CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 3CompletedFinished

1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartAug 1997

Primary CompletionAug 1998

Study CompletionAug 2000

First PostedSep 2010

TodayJul 2026

First PostedSep 16, 2010

Enrollment StartAug 1, 1997

Primary CompletionAug 1, 1998

Study CompletionAug 1, 2000

TodayJul 1, 2026

Enrollment to primary: 1 yearPosted 15.8 years ago

Interventions

Erythropoietindrug

Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.

Sham Comparatorother

Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.