EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns (COOLDECIDE)
11. august 2026 oppdatert av: Assistance Publique - Hôpitaux de Paris
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Antatt)
310
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mathilde LETOUZEY, M.D
- Telefonnummer: + 33171738599
- E-post: mathilde.letouzey@aphp.fr
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Sensitivity and specificity of the algorithm versus the gold standard for discriminating mild vs moderate/severe HIE
Tidsramme: 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.
|
Within the first 6 hours of life
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
PPV, NPV, false-alarm ratio, accuracy, balanced accuracy and F1-score of the algorithm vs gold standard (overall and by subgroup)
Tidsramme: Within the first 6 hours of life
|
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
Tidsramme: During the initial hospitalization (up to 28 days of life)
|
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
Tidsramme: EEG recordings from the first 6 hours of life
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
16. september 2026
Primær fullføring (Antatt)
16. januar 2027
Studiet fullført (Antatt)
16. februar 2027
Datoer for studieregistrering
Først innsendt
3. august 2026
Først innsendt som oppfylte QC-kriteriene
11. august 2026
Først lagt ut (Faktiske)
13. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- APHP261081
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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