EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns (COOLDECIDE)

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perinatal Asphyxia; Hypoxic-Ischemic Encephalopathy; Neonatal Brain Injury

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 310

Contacts and Locations

• Study Contact: Name: Mathilde LETOUZEY, M.D; Phone Number: + 33171738599; Email: mathilde.letouzey@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within the first 6 hours of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	EEG recordings from the first 6 hours of life

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: BPI

Study record dates

Study Major Dates

• Study Start (Estimated): September 16, 2026
• Primary Completion (Estimated): January 16, 2027
• Study Completion (Estimated): February 16, 2027

Study Registration Dates

• First Submitted: August 3, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 13, 2026

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: diagnostic accuracy; therapeutic hypothermia; term newborn; conventional EEG; decision-support software; medical device software
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia; Signs and Symptoms, Respiratory; Hypoxia, Brain; Hypoxia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hypoxia-Ischemia, Brain
• Other Study ID Numbers: APHP261081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No