Optimized bedside brain monitoring for newborns and infants in intensive care
Critical Care Optimized Pediatric Quantitative EEG
This project will try adding extra EEG electrodes and automated analysis to bedside monitoring to better find seizures and other brain problems in babies and children under 2 in intensive care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | N/A to 24 Months |
| Sex | All |
| Sponsor | Nantes University Hospital Academic / other |
| Locations | 1 site (Nantes) |
| Trial ID | NCT06726408 on ClinicalTrials.gov |
What this trial studies
The project configures an 8‑channel aEEG display with complementary displays (CDSA) and automated seizure detection, and expands bedside monitoring to a 10‑electrode montage. Teams will be trained on electrode placement and the use of reading aids, then patients under age 2 in the ICU who need neuromonitoring will be enrolled for continuous bedside recording. Clinical interpretations at the bedside will be available in real time and a neurophysiologist can provide on‑demand readings during office hours. All full EEG recordings will undergo blinded post‑hoc review by a pediatric EEG expert as the gold standard to determine how well the optimized quantitative tools detect seizures and encephalopathy.
Who should consider this trial
Good fit: Infants and young children under 2 years old admitted to the intensive care unit who require neuromonitoring, whose legal representatives consent and are French‑speaking, and who are covered by social security are eligible.
Not a fit: Preterm infants with corrected age under 37 weeks, patients who cannot have electrodes placed (for example after neurosurgery), and those whose families cannot consent in French are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could detect more seizures sooner and help clinicians start treatments that may improve neurological outcomes for critically ill infants.
How similar studies have performed: Prior work shows continuous EEG is the gold standard and amplitude‑integrated EEG has modest seizure detection, but combining an expanded electrode montage with automated detection and targeted neurophysiology input is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria : * Patients younger than 2 years old hospitalized in the intensive care unit with an indication for neuromonitoring. The same patient may be included multiple times. * Written non-opposition from legal representatives. * Patients affiliated with or beneficiaries of a social security or similar scheme (CMU). Exclusion Criteria : * Parents who do not understand French. * Inability to set up monitoring equipment (neurosurgery preventing access to electrode placement sites). * Corrected age \< 37 weeks of gestation (GA) for preterm infants.
Where this trial is running
Nantes
- CHU de Nantes — Nantes, France (Recruiting)
Study contacts
- Study coordinator: Noura ZAYAT, PH
- Email: noura.zayat@chu-nantes.fr
- Phone: 33 2 76 64 37 91
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.