Trial reportPediatrics2013
A randomized, masked, placebo-controlled study of darbepoetin alfa in preterm infants.
Trial report in Pediatrics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 8 of them syntheses that pooled 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.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 8 syntheses or guidelines pooled it, 107 citations in OpenAlex.
- Association of anemia and necrotizing enterocolitis in neonates: Systematic review and meta-analysis of transfusion thresholds, erythropoietin trials, and observational studies.Journal of neonatal-perinatal medicine · 2026Pooled it
- Early erythropoiesis-stimulating agents in preterm or low-birthweight infants.The Cochrane database of systematic reviews · 2026Pooled it
- Interventions to Reduce Severe Brain Injury Risk in Preterm Neonates: A Systematic Review and Meta-analysis.JAMA network open · 2023Pooled it
- Early erythropoietin for preventing necrotizing enterocolitis in preterm neonates - an updated meta-analysis.European journal of pediatrics · 2022Pooled it
- Early erythropoiesis-stimulating agents in preterm or low birth weight infants.The Cochrane database of systematic reviews · 2020Pooled it
- Clinical Outcomes Related to the Gastrointestinal Trophic Effects of Erythropoietin in Preterm Neonates: A Systematic Review and Meta-Analysis.Advances in nutrition (Bethesda, Md.) · 2018Pooled it
- Early erythropoiesis-stimulating agents in preterm or low birth weight infants.The Cochrane database of systematic reviews · 2017Pooled it
- Erythropoietin and retinopathy of prematurity: a meta-analysis.European journal of pediatrics · 2014Pooled it
- A prospective randomized pilot trial comparing weekly vs. biweekly Darbepoetin administration to preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2025Trial
- Preschool Assessment of Preterm Infants Treated With Darbepoetin and Erythropoietin.Pediatrics · 2016Trial
- Cognitive outcomes of preterm infants randomized to darbepoetin, erythropoietin, or placebo.Pediatrics · 2014Trial
- Darbepoetin and Infantile Hemangioma in Premature Infants.Journal of clinical medicine · 2026Article
- Article
- Transfusion targets and adverse events in pediatric perioperative acute Anemia.Journal of clinical anesthesia · 2024Observational
- Transfusion strategies for neonates: current perspectives.Annals of medicine and surgery (2012) · 2024Review
- Anemia, Iron Supplementation, and the Brain.Clinics in perinatology · 2023Review
- Systemic Cytokines in Retinopathy of Prematurity.Journal of personalized medicine · 2023Review
- Characterization of Neutropenia in Preterm Neonates Following Administration of Darbepoetin Alfa.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Free Radicals and Neonatal Brain Injury: From Underlying Pathophysiology to Antioxidant Treatment Perspectives.Antioxidants (Basel, Switzerland) · 2021Review
- Is the erythropoietin-erythroferrone-hepcidin axis intact in human neonates?Blood cells, molecules & diseases · 2021Article
Corrections and comments
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Authors and funding
12 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundA novel erythropoiesis stimulating agent (ESA), darbepoetin alfa (Darbe), increases hematocrit in anemic adults when administered every 1 to 3 weeks. Weekly Darbe dosing has not been evaluated in preterm infants. We hypothesized that infants would respond to Darbe by decreasing transfusion needs compared with placebo, with less-frequent dosing than erythropoietin (Epo).
methodsPreterm infants 500 to 1250 g birth weight and ≤48 hours of age were randomized to Darbe (10 μg/kg, 1 time per week subcutaneously), Epo (400 U/kg, 3 times per week subcutaneously) or placebo (sham dosing) through 35 weeks' gestation. All received supplemental iron, folate, and vitamin E, and were transfused according to protocol. Transfusions (primary outcome), complete blood counts, absolute reticulocyte counts (ARCs), phlebotomy losses, and adverse events were recorded.
resultsA total of 102 infants (946 ± 196 g, 27.7 ± 1.8 weeks' gestation, 51 ± 25 hours of age at first dose) were enrolled. Infants in the Darbe and Epo groups received significantly fewer transfusions (P = .015) and were exposed to fewer donors (P = .044) than the placebo group (Darbe: 1.2 ± 2.4 transfusions and 0.7 ± 1.2 donors per infant; Epo: 1.2 ± 1.6 transfusions and 0.8 ± 1.0 donors per infant; placebo: 2.4 ± 2.9 transfusions and 1.2 ± 1.3 donors per infant). Hematocrit and ARC were higher in the Darbe and Epo groups compared with placebo (P = .001, Darbe and Epo versus placebo for both hematocrit and ARCs). Morbidities were similar among groups, including the incidence of retinopathy of prematurity.
conclusionsInfants receiving Darbe or Epo received fewer transfusions and fewer donor exposures, and fewer injections were given to Darbe recipients. Darbepoetin and Epo successfully serve as adjuncts to transfusions in maintaining red cell mass in preterm infants.
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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.