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Development of a core outcome set for intraventricular haemorrhage (IVH) in preterm infants: a study protocol

Haoran Dou1,2, Yuan Li1,2,3, Ying-Xin Li1,2,3

  • 1Department of Pediatrics, West China Second University Hospital, Sichuan University, Chengdu, China.

BMJ Open
|January 27, 2026
PubMed

Insights

Intraventricular haemorrhage (IVH) in preterm infants causes significant mortality and impairment. This study aims to develop a Core Outcome Set (COS) to standardize IVH research and improve clinical practice for better infant outcomes.

Area of Science:

  • Neonatal Research
  • Clinical Trials
  • Evidence-Based Medicine

Background:

  • Intraventricular haemorrhage (IVH) is a leading cause of mortality and neurodevelopmental issues in preterm infants.
  • Current research on IVH suffers from outcome reporting heterogeneity, hindering meta-analysis and clinical translation.
  • Standardized outcome reporting is crucial for advancing IVH research and improving care for extremely preterm infants.

Purpose of the Study:

  • To develop a Core Outcome Set (COS) for intraventricular haemorrhage (IVH) research in preterm infants.
  • To address the heterogeneity in outcome measurement and reporting in existing IVH studies.
  • To facilitate robust data synthesis and evidence translation for improved clinical practice in neonatal care.

Main Methods:

  • Systematic review of reported outcomes in preterm infant IVH research.
  • Qualitative interviews with clinicians, researchers, and caregivers to identify relevant outcomes.
  • Multiround Delphi survey and consensus meeting to finalize the Core Outcome Set (COS).

Main Results:

  • This section is not applicable as the study is prospective and results are not yet available.

Conclusions:

  • The development of a Core Outcome Set (COS) is essential for standardizing intraventricular haemorrhage (IVH) research.
  • A standardized COS will improve the quality and comparability of research findings.
  • This initiative aims to enhance the translation of evidence into improved clinical management for preterm infants affected by IVH.
Abstract

Keywords:
Health Impact AssessmentIntraventricular haemorrhageMeta-AnalysisNeonatal intensive & critical care

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