Objective To collect data on content/face validity and interobserver agreement for a Neonatal Coma Score (NCS) in well full-term neonates and on construct validity in unwell and preterm babies, specifically how the NCS changed with gestational age and illness. Design Prospective cohort studies. Setting Two UK tertiary neonatal units (Sheffield and Leeds). Patients 151 well full-term (≥37 weeks gestational age) newborn babies recruited between January and February 2020 in Sheffield and April and May 2021 in Leeds; 101 sick preterm and full-term babies admitted to Sheffield neonatal unit between January 2021 and May 2022. Intervention A new NCS. Main outcome measures Determination of normal values in well babies born ≥37 weeks gestational age; data on how the NCS changes with gestational age and illness. Results Face validity was demonstrated during development of the NCS. The median NCS of well, full-term newborn babies was 15 and the intraclass correlation coefficient was 0.78 (95% CI 0.70 to 0.84). In the ‘well’ preterm population, 95% <28 weeks had a score ≥11; 28–31 weeks ≥11; 32–36 weeks ≥13 and 37–44 weeks 14–15. The NCS dropped during periods of deterioration, demonstrating evidence of construct validity. Criterion validity was not assessed. Conclusions The NCS has good intraobserver agreement in well full-term babies, with a normal NCS 14–15. The NCS in preterm neonates depended on gestational age, and deterioration from baseline was associated with illness. Further work is needed to determine normal scores each gestational age, reliability at lower levels, how early the NCS identifies deterioration and comparison with other assessment tools to demonstrate criterion validity. Data are available on reasonable request.

中文翻译：

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关于新新生儿昏迷评分的两项前瞻性队列研究的有效性和可靠性的初步结果

目的 收集健康足月新生儿新生儿昏迷评分 (NCS) 的内容/表面效度和观察者间一致性数据，以及身体不适和早产儿的构建效度数据，特别是 NCS 如何随胎龄和疾病变化。设计前瞻性队列研究。设置两个英国高等教育新生儿单位（谢菲尔德和利兹）。患者 2020 年 1 月至 2 月在谢菲尔德以及 2021 年 4 月至 5 月在利兹招募的 151 名足月（孕龄≥37 周）新生儿；2021 年 1 月至 2022 年 5 月期间，谢菲尔德新生儿病房收治了 101 名患病早产儿和足月儿。 干预措施 新的 NCS。主要结局指标 胎龄≥37周出生的健康婴儿的正常值测定；有关 NCS 如何随胎龄和疾病变化的数据。结果 表面有效性在 NCS 的开发过程中得到了证明。健康的足月新生儿的 NCS 中位数为 15，组内相关系数为 0.78（95% CI 0.70 至 0.84）。在“良好”早产人群中，95% <28 周的人得分≥11；28-31周≥11周；32-36周≥13和37-44周14-15。NCS 在恶化期间下降，证明了结构有效性的证据。未评估标准有效性。结论 对于健康良好的足月婴儿，NCS 具有良好的观察者内一致性，NCS 为 14-15。早产儿的 NCS 取决于胎龄，基线恶化与疾病相关。需要进一步的工作来确定每个胎龄的正常分数、较低水平的可靠性、NCS 多久识别恶化以及与其他评估工具进行比较以证明标准的有效性。可根据合理要求提供数据。