EEG-Based Decision-Support Algorithm for Hypoxic-Ischemic Encephalopathy in Term Newborns
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-1
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Other
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
310 Participants
are grouped into 1 trial groupGroup A: Term newborns with suspected HIE
Trial outcomes
Primary outcomes
1
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 lifeSecondary outcomes
1
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 life2
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)3
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 lifeLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
BPI
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: