Neonatal septic shock is a critical and life-threatening complication of neonatal sepsis characterized by inadequate tissue perfusion and systemic hypotension, necessitating fluid resuscitation or inotropic support. If the progression of sepsis and severer sepsis to septic shock cannot be stopped in time, the probability of end-organ damage and mortality becomes significantly heightened. Two protocols have been registered with the COMET Initiative, with the objective of establishing a core outcome set for neonatal sepsis (Registration number: 2118) and pediatric sepsis, encompassing the neonatal population (Registration number: 1400). However, it is important to note that neither of these protocols specifically targets neonatal septic shock. Although neonatal septic shock represents an advanced and severe stage of neonatal sepsis, it distinguishes itself from the initial condition in various aspects, including definitions, clinical presentations, management strategies, as well as the physiological parameters and patient outcomes that clinicians prioritize and rely upon for informed decision-making. In the context of neonatal septic shock, the management of hypotension and the provision of cardiovascular support are of paramount importance. The primary outcome measures used to evaluate treatment effectiveness in neonatal septic shock frequently focus on the time to vasoactive-free hemodynamic stability and organ dysfunction. In contrast, in neonatal sepsis, a greater emphasis is placed on effectively addressing and combating the underlying infection. In addition, there is significant heterogeneity in the outcomes measured and reported across existing studies conducted to inform the management of neonatal septic shock. This heterogeneity in outcomes poses a challenge as it hinders meaningful comparisons and the pooling of findings, which are essential for drawing comprehensive and reliable conclusions. In this project, we aim to develop a core outcome set that can be used in both research and routine clinical care for management of neonatal septic shock. The study will be conducted in a four-stage process: (1) scoping review, (2) expert stakeholder meeting, (3) two-round e-Delphi survey, and (4) consensus meeting. The development of the core outcome set will serve to ensure the consistency of reporting clinical study outcomes, assist in reducing reporting bias, and facilitate the audits of clinical practices pertaining to the management of neonatal septic shock in the future.
ContributorsProf. Tang Jun, Department of neonatology, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China (principal investigator)
Prof. Shi Jing, Department of neonatology, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education, Chengdu, China
Ms. Hu Yanling, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Dr. Wan Xingli, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Dr. Li Yuan, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Ms. Li Xia, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Dr. Lu Meizhu, Department of neonatology, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Ms. Li Ying-Xin, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Ms. Guo Xuemei, Department of neonatology nursing, West China Second University Hospital, Sichuan University / Key Laboratory of Birth Defects and Related Diseases of Women and Children (Sichuan University), Ministry of Education / West China School of Nursing, Chengdu, China
Disease Category: Neonatal care
Disease Name: Septic shock
Age Range: 0
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Families
- Methodologists
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Delphi process
- Literature review
- Semi structured discussion
The COS development workflow will proceed in four stages: (1) scoping review, (2) expert stakeholder meeting, (3) two-round e-Delphi survey, and (4) consensus meeting.