Retrospective Multicenter Validation of a Conventional EEG-Based Decision-Support Algorithm to Discriminate Mild Versus Moderate/Severe Hypoxic-Ischemic Encephalopathy in Term Newborns (Newborn Neuro Digital Project)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 310
- 主要终点
- Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
研究概览
简要总结
This retrospective, multicenter, observational study evaluates how well a decision-support algorithm can tell apart mild forms of hypoxic-ischemic encephalopathy (HIE) from moderate or severe forms in full-term newborns born after a lack of oxygen around birth (perinatal asphyxia). The algorithm reads the raw (non-compressed) EEG signal. Its output is compared with the reference reading of the full conventional EEG made by a panel of pediatric neurophysiologists together with the baby's clinical information. The study uses only medical data that already exists and asks nothing of the babies or their families.
详细描述
The algorithm under investigation was developed in a previous retrospective clinical study (registered as NCT05114070; French CNIL/ethics ref CER-2021-023; approved by the Sorbonne University ethics committee) and is based on background-rhythm analysis of EEG. Newborns are analyzed in two subgroups: those who received a treatment liable to modify the EEG tracing, and those who did not. Conventional EEG recordings are collected from the neurophysiology departments of participating level-3 maternity hospitals over the period 01 January 2016 to 30 April 2026. No follow-up or sampling is performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No parental opposition to the use of the child's medical data within 1 month of the mailed information notice
- •Gestational age ≥ 36 weeks of amenorrhea
- •Birth weight ≥ 1800 g
- •Born in a context of perinatal asphyxia (any cause) leading to suspected HIE, with EITHER biological signs of metabolic acidosis (pH ≤ 7 or base deficit ≥ 16 mmol/L or lactate ≥ 11 mmol/L within the first hour of life, any blood sample) OR a history of asphyxia with Apgar ≤ 5 at 10 minutes or need for ventilatory resuscitation continued at 10 minutes of life
- •Non-compressed conventional EEG (EEGc) recorded before the 6th hour of life
- •EEG including the signal of active electrodes Fp1, Fp2, T3 and T4
排除标准
- •Participation in a therapeutic biomedical research liable to modify the EEG tracing
- •Fewer than 20 minutes of artifact-free EEG recording
- •Signal from active electrodes Fp1, Fp2, T3 and T4 not exploitable
研究组 & 干预措施
Term newborns with suspected HIE
Single study population: term newborns (≥ 36 weeks, ≥ 1800 g) with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, with an available non-compressed conventional EEG. This is a diagnostic-accuracy validation study (STARD), not a comparative two-arm design. The treated / untreated distinction is a pre-specified analysis subgroup only, not a study group.
结局指标
主要结局
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
时间窗: Within the first 6 hours of life
Diagnostic performance computed against the reference EEG reading by pediatric neurophysiologists complemented by clinical data; 95% confidence intervals by the exact (Clopper-Pearson) method.
次要结局
- PPV, NPV, false-alarm ratio, accuracy, balanced accuracy and F1-score of the algorithm vs gold standard (overall and by subgroup)(Within the first 6 hours of life)
- Proportion of transfers not leading to therapeutic hypothermia(During the initial hospitalization (up to 28 days of life))
- Evaluate the inter-rater agreement between the first two expert neurophysiologists(EEG recordings from the first 6 hours of life)