ArticleBMJ open2021
Integrating neuroimaging biomarkers into the multicentre, high-dose erythropoietin for asphyxia and encephalopathy (HEAL) trial: rationale, protocol and harmonisation.
Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02811263 (High-dose Erythropoietin for Asphyxia and Encephalopathy), which is not on this map. Cited by 19 papers.
What it found
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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.
High-dose Erythropoietin for Asphyxia and Encephalopathy
Who cites it
19 citing papers in PubMed, 20 citations in OpenAlex.
- Chorioamnionitis and Two-Year Outcomes in Infants with Hypoxic-Ischemic Encephalopathy.The Journal of pediatrics · 2025Trial
- Esophageal Versus Rectal Temperature Monitoring During Whole-Body Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: Association with Short- and Long-Term Outcomes.The Journal of pediatrics · 2024Trial
- Brain Injury Outcomes after Adjuvant Erythropoietin Neuroprotection for Moderate or Severe Neonatal Hypoxic-Ischemic Encephalopathy: A Report from the HEAL Trial.Developmental neuroscience · 2024Trial
- How well does neonatal neuroimaging correlate with neurodevelopmental outcomes in infants with hypoxic-ischemic encephalopathy?Pediatric research · 2023Trial
- Safety of High Dose Erythropoietin Used with Therapeutic Hypothermia as Treatment for Newborn Hypoxic-Ischemic Encephalopathy: Secondary Analysis of the HEAL Randomized Controlled Trial.The Journal of pediatrics · 2023Trial
- Trial of Erythropoietin for Hypoxic-Ischemic Encephalopathy in Newborns.The New England journal of medicine · 2022Trial
- Magnetic resonance imaging and spectroscopy in neonatal encephalopathy: current consensus position and future opportunities.Pediatric research · 2026Review
- Neuroimaging of neonatal brain post therapeutic hypothermia: a practical guide to the non-pediatric neuroradiologist.Frontiers in radiology · 2026Review
- Neonatal encephalopathy and hypoxic-ischemic encephalopathy: the state of the art.Pediatric research · 2025Review
- Timing of initiation of therapeutic hypothermia in neonates with hypoxic ischemic encephalopathy born at a high-volume urban safety net hospital.Early human development · 2025Article
- Perinatal arterial ischemic stroke diagnosed in infants receiving therapeutic hypothermia for hypoxic-ischemic encephalopathy.Pediatric research · 2025Article
- A Pediatric Research Imperative: Addressing Neonates in Drug Development Through Understanding Neonatal Clinical Pharmacology.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025Article
- The predictive value of MRI scores for neurodevelopmental outcome in infants with neonatal encephalopathy.Pediatric research · 2025Article
- Predictors of Death or Severe Impairment in Neonates With Hypoxic-Ischemic Encephalopathy.JAMA network open · 2024Article
- Automated neonatal nnU-Net brain MRI extractor trained on a large multi-institutional dataset.Scientific reports · 2024Article
- Advancing brain MRI as a prognostic indicator in hypoxic-ischemic encephalopathy.Pediatric research · 2024Article
- Article
- Placental Histologic Abnormalities and 2-Year Outcomes in Neonatal Hypoxic-Ischemic Encephalopathy.Neonatology · 2023Article
- Harmonization of multi-scannerFrontiers in neurology · 2022Review
Corrections and comments
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Authors and funding
34 authors at 20 institutions in 3 countries.
Funding
Abstract
introductionMRI and MR spectroscopy (MRS) provide early biomarkers of brain injury and treatment response in neonates with hypoxic-ischaemic encephalopathy). Still, there are challenges to incorporating neuroimaging biomarkers into multisite randomised controlled trials. In this paper, we provide the rationale for incorporating MRI and MRS biomarkers into the multisite, phase III high-dose erythropoietin for asphyxia and encephalopathy (HEAL) Trial, the MRI/S protocol and describe the strategies used for harmonisation across multiple MRI platforms. METHODS AND ANALYSIS: Neonates with moderate or severe encephalopathy enrolled in the multisite HEAL trial undergo MRI and MRS between 96 and 144 hours of age using standardised neuroimaging protocols. MRI and MRS data are processed centrally and used to determine a brain injury score and quantitative measures of lactate and n-acetylaspartate. Harmonisation is achieved through standardisation-thereby reducing intrasite and intersite variance, real-time quality assurance monitoring and phantom scans. ETHICS AND DISSEMINATION: IRB approval was obtained at each participating site and written consent obtained from parents prior to participation in HEAL. Additional oversight is provided by an National Institutes of Health-appointed data safety monitoring board and medical monitor. TRIAL REGISTRATION NUMBER: NCT02811263; Pre-result.
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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.