An observational study in Encephalopathy, sponsored by Institut Investigacio Sanitaria Pere Virgili. Not yet recruiting. Open to participants aged 26 Weeks to 41 Weeks. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Institut Investigacio Sanitaria Pere Virgili · Observational
This multicentre, observational, prospective and comparative study aims to validate the use of the new aCUP-E electrode for aEEG monitoring in newborns admitted to the NICU, comparing it with conventional electrodes currently used at two hospitals: Salut Sant Joan de Reus - Baix Camp and Hospital Universitari de Tarragona Joan XXIII.
A total of 35 newborns at risk of encephalopathy will be recruited.
During aEEG monitoring, one type of electrode will be placed on each cerebral hemisphere: on one hemisphere, the standard electrode normally used according to each hospital's protocol, and on the other, the new aCUP-E electrode. This design allows direct comparison under similar conditions to assess recording quality, reliability and ease of use. The multicentre methodology also facilitates a more representative and diverse sample, increasing the robustness and generalisability of the results.
This study seeks to determine whether aCUP-E can replace conventional electrodes, offering a safe and effective alternative that improves the quality of neonatal neurological monitoring and adapts to different clinical contexts.
502 studies on the registry are indexed under Brain Diseases; 141 are open to participants now.
This study's planned enrollment of 35 is below the median of 149 across 144 observational studies indexed under Brain Diseases.
Browse Brain Diseases studies →Institut Investigacio Sanitaria Pere Virgili is the lead sponsor of 39 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Overall, the three cohorts together involve the inclusion of a maximum of 35 neonates, a number considered adequate to achieve the technical, functional and clinical objectives of the study, while maintaining a balance between methodological robustness, recruitment feasibility and minimisation of the care burden on an especially vulnerable population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first cohort will include 10 neonates, in whom an intra-individual comparison between aCUP-E and conventional liquid-gel electrodes will be performed. The main objective of this cohort is to externally validate the results obtained in the previous study authorised by the Spanish Agency of Medicines and Medical Devices (AEMPS), file 918/21/EC-R, the results of which were subsequently published by Fabregat-Sanjuan et al. (Frontiers in Pediatrics, 2024). Therefore, the results obtained in these ten new patients will be compared with the results previously obtained in the initial study, with the aim of verifying the reproducibility of aCUP-E performance at a second hospital and confirming that its performance does not depend on the participating centre or the staff responsible for electrode placement.
The second cohort will include 15 neonates, all recruited at Hospital Universitari de Tarragona Joan XXIII (HUJ23). In this cohort, a simultaneous comparison between aCUP-E and the needle electrodes routinely used in clinical practice will be performed. This is the first specific clinical evaluation between the two recording systems. In a paired intra-individual design, a cohort of approximately 10 neonates would allow an initial assessment of comparative performance to detect large intra-individual differences.
The third cohort will include 10 neonates monitored exclusively using aCUP-E electrodes. This cohort is expected to be distributed evenly between the two participating centres, including approximately 5 neonates at Hospital Universitari de Tarragona Joan XXIII (HUJ23) and 5 neonates at Hospital Universitari Sant Joan de Reus (HUSJR), provided that the recruitment rate allows it. The main objective of this cohort is not to compare different types of electrodes, but to evaluate the technical feasibility, functional stability and safety of exclusive use of aCUP-E during complete monitoring sessions.
1. To compare the overall recording quality of aCUP-E with that of commercial electrodes.
This analysis will be performed in preterm and term newborns at risk of encephalopathy, selecting segments with low impedance and absence of artefacts to determine recording quality. The outcome will be a % of time of the recording with good quality
Time frame: Through study completion, an average of 2 years
2. To evaluate the clinical feasibility of aCUP-E
This outcome will evaluate the clinical feasibility in relation with standard practice. The outcome will be the results of a survey from clinicians.
Time frame: Through study completion, an average of 2 years
3. To evaluate the safety of aCUP-E
This outcome will evaluate the safety of the electrode. The outcome will be the results of a survey from clinicians.
Time frame: Through study completion, an average of 2 years
4. To evaluate the reliability of aCUP-E recordings
This outcome will evaluate the differences between recordings. The outcome will be the % of differences between recordings.
Time frame: Through study completion, an average of 2 years
5. To evaluate electrode survival and durability
This outcome will evaluate the time to use in good conditions the electrode. The outcome will be the number of hours as a function of the % of survival.
Time frame: Through study completion, an average of 2 years
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Start is estimated for Oct 2026; primary completion for Oct 2027, 11 months later.
Of 78 non-industry observational studies under Brain Diseases, half reached primary completion within 62 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 193. This study's planned 11 months is below that.
Counting every sponsor, half of 87 studies reached it within 62 months; a quarter within 22 and three quarters within 193.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Institut Investigacio Sanitaria Pere Virgili