Evidence map›Paper›PMID 25996892›Full record

Trial reportPediatric research2015

Darbepoetin administration to neonates undergoing cooling for encephalopathy: a safety and pharmacokinetic trial.

Mariana C Baserga, Joanna C Beachy, Jessica K Roberts, Robert M Ward, Robert J DiGeronimo, William F Walsh, Robin K Ohls, Jennifer Anderson, Dennis E Mayock, Sandra E Juul and 6 more

Abstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Pediatric research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Review
  9. Review
  10. Article
  11. Review
  12. Characterization of Neutropenia in Preterm Neonates Following Administration of Darbepoetin Alfa.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023
    Article
  13. Review
  14. Review
  15. Review
  16. Emerging therapies and management for neonatal encephalopathy-controversies and current approaches.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Review
  17. Review
  18. Article
  19. Review
  20. Review
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

16 authors.

Mariana C BasergaDivision of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Joanna C BeachyDivision of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Jessica K RobertsDivision of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Robert M Ward1] Division of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah [2] Division of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Robert J DiGeronimoDivision of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
William F WalshDivision of Neonatology, Department of Pediatrics, Vanderbilt University, Nashville, Tennessee.
Robin K OhlsDivision of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque, New Mexico.
Jennifer AndersonDivision of Neonatology, Department of Pediatrics, University of New Mexico, Albuquerque, New Mexico.
Dennis E MayockDivision of Neonatology, Department of Pediatrics, University of Washington, Seattle, Washington.
Sandra E JuulDivision of Neonatology, Department of Pediatrics, University of Washington, Seattle, Washington.ORCID 0000000268616229
Robert D ChristensenIntermountain Healthcare, McKay Dee Hospital, Ogden, Utah.
Manndi C LoertscherDivision of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Chris StockmannDivision of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Catherine M T SherwinDivision of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Michael G SpigarelliDivision of Clinical Pharmacology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.
Bradley A YoderDivision of Neonatology, Department of Pediatrics, University of Utah, Salt Lake City, Utah.

Funding

University of Utah Center for Clinical and Translational ScienceUL1TR001067 · NCATS · UNIVERSITY OF UTAH · PI DERE, WILLARD H., HESS, RACHEL · 2013 to 2017
$19.8M
NCATS NIH HHS UL1 TR001067
6 · The paper itself

Abstract

backgroundDespite therapeutic hypothermia, neonates with encephalopathy (NE) have high rates of death or disability. Darbepoetin alfa (Darbe) has comparable biological activity to erythropoietin, but has extended circulating half-life (t(1/2)). Our aim was to determine Darbe safety and pharmacokinetics as adjunctive therapy to hypothermia. STUDY

designThirty infants (n = 10/arm) ≥36 wk gestation undergoing therapeutic hypothermia for NE were randomized to receive placebo, Darbe low dose (2 μg/kg), or high dose (10 μg/kg) given intravenously within 12 h of birth (first dose/hypothermia condition) and at 7 d (second dose/normothermia condition). Adverse events were documented for 1 mo. Serum samples were obtained to characterize Darbe pharmacokinetics.

resultsAdverse events (hypotension, altered liver and renal function, seizures, and death) were similar to placebo and historical controls. Following the first Darbe dose at 2 and 10 μg/kg, t(1/2) was 24 and 32 h, and the area under the curve (AUC(inf)) was 26,555 and 180,886 h*mU/ml*, respectively. In addition, clearance was not significantly different between the doses (0.05 and 0.04 l/h). At 7 d, t(1/2) was 26 and 35 h, and AUC(inf) was 10,790 and 56,233 h*mU/ml*, respectively (*P < 0.01).

conclusionDarbe combined with hypothermia has similar safety profile to placebo with pharmacokinetics sufficient for weekly administration.

Indexed as

Hypothermia, InducedAdolescentAdultArea Under CurveBrain DiseasesDarbepoetin alfaDose-Response Relationship, DrugDrug Administration ScheduleErythropoietinFemaleHumansHypothermiaInfant, NewbornMagnetic Resonance ImagingMaleYoung AdultDarbepoetin alfaErythropoietin

Identifiers

PMID25996892
PMCPMC5564328

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.