An observational study in Hypoxic-Ischemic Encephalopathy, Perinatal Asphyxia and Neonatal Brain Injury, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting. Open to participants aged 0 Days to 1 Day. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
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.
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.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 310 is above the median of 89 across 92 observational studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.
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Term newborns ≥ 36 weeks gestational age, birth weight ≥ 1800 g, with suspected hypoxic-ischemic encephalopathy in a context of perinatal asphyxia, whose non-compressed conventional EEG recordings are available in participating centers.
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Exclusion Criteria:
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.
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
Diagnostic performance computed against the reference EEG reading by pediatric neurophysiologists complemented by clinical data; 95% confidence intervals by the exact (Clopper-Pearson) method.
Time frame: Within the first 6 hours of life
PPV, NPV, false-alarm ratio, accuracy, balanced accuracy and F1-score of the algorithm vs gold standard (overall and by subgroup)
Secondary diagnostic-performance metrics computed overall and within the treated / untreated subgroups.
Time frame: Within the first 6 hours of life
Proportion of transfers not leading to therapeutic hypothermia
Share of included newborns not treated by therapeutic hypothermia at the time, including those transferred from a level 1/2a/2b maternity or managed within the same facility.
Time frame: During the initial hospitalization (up to 28 days of life)
Evaluate the inter-rater agreement between the first two expert neurophysiologists
Inter-rater agreement will be assessed using Cohen's kappa coefficient (κ), with a 95% confidence interval.
Time frame: EEG recordings from the first 6 hours of life
No study locations are listed for this record.
Plan to share: No — AP-HP is the sole owner of the data. Individual participant data are not planned to be shared; any use or transmission to a third party requires the sponsor's prior authorization, under conditions ensuring confidentiality and a level of protection equivalent to EU legislation.
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Jan 2027, 4 months later.
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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