Department of General Pediatrics, Neonatology and Pediatric Cardiology, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Düsseldorf Germany.
Clinic for Gynecology and Obstetrics, Medical Faculty, University Hospital Düsseldorf, Heinrich-Heine-University, Düsseldorf, Germany.
J Pediatr. 2022 Jun;245:22-29.e2. doi: 10.1016/j.jpeds.2022.02.045. Epub 2022 Feb 28.
To evaluate, using video documentation, the sensitivity, specificity, and interobserver reliability of visualizable signs of neonatal hypoglycemia at different glucose concentrations in neonates.
In a prospective cohort study of 145 neonates with and without risk factors for hypoglycemia, 430 videos were recorded before blood glucose measurements and analyzed by 10 blinded investigators of different professions. The primary outcome measures were sensitivity and specificity for clinical detection of hypoglycemia.
The overall sensitivity to detect low blood glucose (<55 mg/dL [<3.1 mmol/L]) based on signs was 30%, and the specificity was 82%. Significantly more investigators suspected hypoglycemia while viewing videos of infants with blood glucose levels of 46-54 mg/dL (2.6-3.0 mmol/L) and 30-45 mg/dL (1.7-2.5 mmol/L) compared with ≥55 mg/dL (≥3.1 mmol/L) (29 ± 3% and 31 ± 4% vs 18 ± 1%; P = .001; P = .007). After 48 hours of life, significantly more investigators suspected hypoglycemia in videos of infants with blood glucose levels of ≤45 mg/dL (≤2.5 mmol/L) compared with blood glucose levels of >45 mg/dL (>2.5 mmol/L) (28.9 ± 8.1% vs 10.9 ± 1.8%; P = .007). For blood glucose levels 30-45 mg/dL (1.7-2.5 mmol/L), sensitivity varied widely between investigators, ranging from 5% to 62%. Three hypoglycemic episodes <30 mg/dL (<1.7 mmol/L) were only partially recognized.
Clinical observation of signs is neither sensitive nor specific to detect neonatal hypoglycemia, and there are large interobserver differences. Thus, guidelines on neonatal hypoglycemia should reconsider whether distinguishing between asymptomatic and symptomatic hypoglycemia provides useful information for the management of neonatal hypoglycemia, because it may pose a risk for systematic under-recognition and undertreatment, leading to an increased risk for neurodevelopmental impairment.
German Clinical Trials Register: DRKS00021500 www.drks.de/drks_web/setLocale_EN.do.
通过视频记录评估不同血糖浓度下新生儿低血糖可视征象的敏感性、特异性和观察者间可靠性。
在一项有或无低血糖风险因素的 145 例新生儿的前瞻性队列研究中，在进行血糖测量前记录了 430 个视频，并由 10 名不同专业的盲法观察者进行分析。主要结局指标是临床检测低血糖的敏感性和特异性。
根据征象总体上检测到低血糖（<55mg/dL [<3.1mmol/L]）的敏感性为 30%，特异性为 82%。与血糖水平≥55mg/dL（≥3.1mmol/L）相比，观看血糖水平为 46-54mg/dL（2.6-3.0mmol/L）和 30-45mg/dL（1.7-2.5mmol/L）的婴儿视频时，更多的观察者怀疑低血糖（29±3%和 31±4%比 18±1%；P=.001；P=.007）。出生后 48 小时，与血糖水平>45mg/dL（>2.5mmol/L）相比，血糖水平≤45mg/dL（≤2.5mmol/L）的婴儿视频中，更多的观察者怀疑低血糖（28.9±8.1%比 10.9±1.8%；P=.007）。对于血糖水平 30-45mg/dL（1.7-2.5mmol/L），不同观察者之间的敏感性差异很大，范围为 5%-62%。3 例血糖水平<30mg/dL（<1.7mmol/L）的低血糖发作仅部分被识别。
临床观察征象既不敏感也不特异于检测新生儿低血糖，且观察者间存在较大差异。因此，新生儿低血糖指南应重新考虑无症状与有症状低血糖之间的区分是否为新生儿低血糖管理提供有用信息，因为这可能会导致系统性识别不足和治疗不足，从而增加神经发育受损的风险。
德国临床试验注册处：DRKS00021500www.drks.de/drks_web/setLocale_EN.do.
