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

Intraventricular haemorrhage (IVH) remains a major contributor to mortality and long-term neurodevelopmental impairment among preterm infants, particularly those born extremely preterm or extremely low birth weight. Although extensive research has investigated various facets of IVH, including prevention, therapeutic interventions, underlying pathophysiology and long-term outcomes, the heterogeneity in selection, measurement and reporting across studies significantly impairs data synthesis through meta-analysis and limits the translation of evidence into clinical practice. To address this issue, we propose the development of a Core Outcome Set (COS) for IVH research in preterm infants.

This study will follow established guidance from the Core Outcome Measures in Effectiveness Trials Initiative and COS-Standards for Development. The sequential phases include: (1) a systematic review to comprehensively identify outcomes previously reported in IVH research involving preterm infants; (2) qualitative interviews with diverse stakeholders (clinicians, researchers and caregivers) to explore perspectives and identify additional relevant outcomes; (3) a multiround Delphi survey to achieve consensus on core outcomes; and (4) a consensus meeting to finalise the COS.

The entire project has been approved by the Ethics Committee of West China Second University Hospital (No. 2022-069). Written informed consent will be obtained from all participants prior to participation. Study findings will be disseminated through conferences and publications in peer-reviewed journals.