Evidence map›Paper›PMID 16151471›Full record

ArticleJournal of perinatology : official journal of the California Perinatal Association2005

Single-dose darbepoetin administration to anemic preterm neonates.

Teresa L Warwood, Robin K Ohls, Susan E Wiedmeier, Diane K Lambert, Cory Jones, Scott H Scoffield, Gupta Neeraj, Peter Veng-Pedersen, Robert D Christensen

Registry-linked trialAbstract read
PubMed Publisher
In one paragraph

Article in Journal of perinatology : official journal of the California Perinatal Association, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00334737 (A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants), which is not on this map. Cited by 24 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 6 pooled it
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00334737 phase2completednot on this mapstarted 2006, after this paper: background citation

A Randomized, Masked, Placebo Controlled Study to Assess the Safety and Efficacy of Darbepoetin Alfa Administered to Preterm Infants

TypeinterventionalSponsorUniversity of New MexicoRan2006 to 2014Enrolled102ConditionsInfant, NewbornArmsDarbepoetin Alfa Injection, erythropoietin alfa injection, sham injection
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 6 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Pooled it
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  7. A prospective randomized pilot trial comparing weekly vs. biweekly Darbepoetin administration to preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2025
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  14. Intravenous administration of darbepoetin to NICU patients.Journal of perinatology : official journal of the California Perinatal Association · 2006
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  19. Why do four NICUs using identical RBC transfusion guidelines have different gestational age-adjusted RBC transfusion rates?Journal of perinatology : official journal of the California Perinatal Association · 2015
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  20. Estimating the nucleated red blood cell 'emergence time' in neonates.Journal of perinatology : official journal of the California Perinatal Association · 2014
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Teresa L WarwoodIntermountain Health Care, Neonatology Clinical Research Group, McKay-Dee Hospital, Ogden, UT 84403, USA.
Robin K Ohls
Susan E Wiedmeier
Diane K Lambert
Cory Jones
Scott H Scoffield
Gupta Neeraj
Peter Veng-Pedersen
Robert D Christensen
Intermountain Healthcare · USMcKay Dee Hospital · USUniversity of Iowa · USUniversity of New Mexico · USUniversity of Utah · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDarbepoetin is longer acting and more potent than recombinant erythropoietin (rEpo). In certain situations, preterm neonates might benefit from rEpo, and for such patients darbepoetin would require fewer doses at a lower cost. However, the proper dose and dosing interval have not been established. STUDY

designWe performed a prospective trial in two level III Neonatal Intensive Care Units. Patients <32 weeks gestation at birth, with a birth weight (BW) <1500 g, were eligible for participation if they were >21-days-old and had a hemoglobin (Hgb) concentration </or=10.5 g/dl. In all, 12 were to receive a single subcutaneous (s.c.) dose at either 1 or 4 microg/kg. Once before the dose was given, and at two preset intervals after, blood was obtained for immature reticulocyte fraction (IRF) and absolute reticulocyte count (ARC). Once before and at four preset intervals after, blood was obtained for pharmacokinetic studies.

resultsThe 12 subjects had BWs of 1129+/-245 g (mean+/-SD), were 29.2+/-1.2 weeks gestation at delivery, and were 43+/-12 days old with an Hgb concentration of 9.6+/-1.0 g/dl when the darbepoetin was given. Six received 1 microg/kg and six 4 microg/kg. The IRF increased (p<0.05) as did the ARC (p<0.05). The increases in IRF were somewhat greater among the 4 microg/kg recipients (P=0.06). The highest recorded concentrations of drug occurred 6 to 12 hours after administration. The combined 6 and 12 hours values were 185+/-106 mU/ml in the 1 microg/kg group vs 597+/-238 in the 4 microg/kg group (p<0.002). The t(1/2) was 26 hours (range 10 to 50). The biovailability-normalized clearance was 19 ml/hour/kg (range 5 to 54).

conclusionsA single s.c. dose of darbepoetin given to preterm neonates accelerated effective erythropoiesis. The pharmacodynamic and pharmacokinetic findings suggest that darbepoetin dosing in neonates would require a higher unit dose/kg and a shorter dosing interval than are generally used for anemic adults.

Indexed as

Anemia, NeonatalArea Under CurveBiological AvailabilityDarbepoetin alfaErythropoietinHalf-LifeHumansInfant, NewbornInfant, PrematureInfant, Premature, DiseasesInfant, Very Low Birth WeightPilot ProjectsProspective StudiesReticulocyte CountDarbepoetin alfaErythropoietin

Identifiers

PMID16151471
OpenAlexW2013412830

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.