Intraventricular Hemorrhage (IVH) in preterm infants poses a significant global public health challenge, especially among extremely low birth weight (ELBW) neonates who are highly vulnerable to this condition. IVH can lead to severe neurological impairments, developmental delays, and even mortality, highlighting the urgent need for timely and effective interventions. Although extensive research has explored IVH management strategies to improve outcomes, inconsistencies in outcome measures across studies impede meaningful comparisons, data aggregation, and meta-analyses, making it difficult to establish optimal care pathways. To address this, a Core Outcome Set (COS) is essential, providing a standardized collection of critical outcomes determined through consensus-building with diverse stakeholders, including clinicians, researchers, patients, and families. Implementing a COS in IVH treatment trials could enhance the consistency and comparability of study results, facilitating robust meta-analyses and accelerating the application of evidence-based treatments in clinical practice.
ContributorsPrincipal investigator and supervisors: Tao XIONG, West China Second University Hospital, Sichuan University, Sichuan, China
Yi Yang, West China Second University Hospital, Sichuan University, Sichuan, China
Jiaqian Wu, West China Second University Hospital, Sichuan University, Sichuan, China
Haoran Dou, West China Second University Hospital, Sichuan University, Sichuan, China
Yuan Li, West China Second University Hospital, Sichuan University, Sichuan, China
Yingxin Li, West China Second University Hospital, Sichuan University, Sichuan, China
Dengjun Liu, West China Second University Hospital, Sichuan University, Sichuan, China
Jun Tang, West China Second University Hospital, Sichuan University, Sichuan, China
Disease Category: Neonatal care
Disease Name: Intraventricular Hemorrhage (IVH)
Age Range: 0 - 2
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Families
- Methodologists
- Patient/ support group representatives
- Policy makers
- Researchers
- Service providers
- Statisticians
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Interview
- Systematic review
This study will use a multi-phase approach to develop a core outcome set (COS) for intraventricular hemorrhage (IVH) in preterm infants. The methods include:
1. Systematic Review: Identify and summarize reported outcomes in previous studies related to IVH in preterm infants.
2. Qualitative Research: Conduct interviews or focus groups with key stakeholders, including clinicians, researchers, and parents, to identify additional relevant outcomes.
3. Delphi Survey: Engage a panel of international experts, healthcare professionals, and parents in a modified Delphi process to prioritize and achieve consensus on core outcomes.
4. Consensus Meeting: Hold a final consensus meeting with key stakeholders to finalize the core outcome set.
5. Dissemination: Develop a dissemination strategy to promote adoption of the core outcome set in future research and clinical practice.
The study will adhere to the COMET initiative’s guidelines and include diverse stakeholder representation to ensure relevance and applicability.