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Data harmonization framework for neonatal hypoxic-ischemic encephalopathy studies.

Chuan-Heng Hsiao1, Anna N Foster1, Scott A McDonald2

  • 1Fetal-Neonatal Neuroimaging Developmental Science Center, Division of Newborn Medicine, Department of Pediatrics, Boston Children's Hospital, Harvard Medical School, Boston, MA 02115, United States.

JAMIA Open
|September 8, 2025
PubMed
Summary
This summary is machine-generated.

A new data harmonization framework for neonatal hypoxic-ischemic encephalopathy (HIE) was developed. This framework successfully identified strong predictor-outcome associations, paving the way for advanced prognostic biomarker development in HIE.

Keywords:
biomarker developmentcommon data elementsdata harmonization frameworkhypoxic-ischemic encephalopathy

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Area of Science:

  • Neonatal neurology
  • Biostatistics
  • Clinical informatics

Background:

  • Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of brain injury in newborns.
  • Developing prognostic biomarkers for HIE is crucial for guiding treatment and improving outcomes.
  • Existing HIE datasets are often heterogeneous, hindering large-scale analysis and biomarker discovery.

Purpose of the Study:

  • To create a data harmonization framework for neonatal HIE studies.
  • To demonstrate the framework's utility in identifying prognostic biomarkers for HIE.

Main Methods:

  • Variables from two large HIE clinical trials were categorized chronologically and by medical topic.
  • A dictionary was developed to standardize variable names and coding.
  • Data were merged, and variable associations with 18- to 22-month neurodevelopmental outcomes were analyzed using Pearson's correlation.

Main Results:

  • A dictionary of 1181 variables from 532 patients was created.
  • Strong associations were found between predictor and outcome variables.
  • Modified Sarnat scores and NRN MRI injury scores showed significant links to neurodevelopmental outcomes.

Conclusions:

  • A robust data harmonization framework for HIE research has been established.
  • The framework facilitates the identification of strong predictor-outcome associations.
  • This approach enables the development of advanced prognostic biomarkers for neonatal HIE.