EncephalopathyaCUP HUSJR/J23NCT07923227
This Multicentre Study Compares aCUP-E With Standard Electrodes During aEEG Monitoring in NICU Newborns at Risk of Encephalopathy, Assessing Recording Quality, Reliability, Ease of Use and Safety.
An observational study of Encephalopathy, run by Institut Investigacio Sanitaria Pere Virgili.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 26 to 41 weeks
- Conditions the study is for
- Encephalopathy
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 14 Oct 2028
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 41 weeks
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- Preterm or term newborns admitted to the NICU who are at risk of encephalopathy due to conditions arising from the clinical context. For example, maternal infection (e.g. maternal infections such as fever during labour, urinary tract infection, etc.), maternal history of gestational diabetes, gestational hypertension or preeclampsia, history of delivery complications such as placental displacement or abnormal placentation.
- Informed consent obtained from the parents or legal guardians of the newborns.
- Availability of aEEG monitoring equipment and aCUP-E electrodes during the study period.
Who cannot join
- Newborns with signs or symptoms of encephalopathy or any other evident neurological abnormality.
- Newborns with critical or unstable medical conditions that interfere with monitoring, such as the need for continuous mechanical ventilation or significant haemodynamic instability.
- Newborns receiving medication that may alter brain activity and interfere with aEEG results.
- Newborns with cranial or skin malformations that prevent proper electrode placement.
- Situations requiring urgent interventions that may interrupt monitoring or affect the quality of the data collected.
- Lack of informed consent from the parents or legal guardians of the newborns to participate in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Vicenç Pascual, Clinical Neurophisyiologist contact
About this study
Official title: Anàlisis Comparatiu Del Registre aEEG Realitzat Amb Elèctrodes Comercials i Amb l'Elèctrode aCUP-E (Advanced Cup Electrode) en Nounats Amb Risc de Patir Una Encefalopatia
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.
Read more
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.
- Conditions
- Encephalopathy
- Keywords
- aEEG, encephalopathy, quiet sleep cycles, EEG electrode
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1. Comparison between aCUP-E and liquid-gel electrodes | 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. | |
| Cohort 2. Comparison between aCUP-E and needle electrodes | 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. | |
| Cohort 3. Monitoring exclusively using aCUP-E | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start15 Oct 2026 (estimated)
- Primary completion14 Oct 2027 (estimated)
- Study completion14 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Institut Investigacio Sanitaria Pere Virgili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923227
- Sponsor's protocol ID
- 196/2025
- Acronym
- aCUP HUSJR/J23
- Status last verified
- Nov 2026
- First submitted
- 13 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anàlisis Comparatiu Del Registre aEEG Realitzat Amb Elèctrodes Comercials i Amb l'Elèctrode aCUP-E (Advanced Cup Electrode) en Nounats Amb Risc de Patir Una Encefalopatia
- ClinicalTrials.gov ID
- NCT07923227
- Acronym / sponsor ID
- aCUP HUSJR/J23 / 196/2025
- Conditions
- Encephalopathy
- Keywords
- aEEG, encephalopathy, quiet sleep cycles, EEG electrode
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Institut Investigacio Sanitaria Pere VirgiliUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 14 Oct 2027 (estimated)
- Study completion
- 14 Oct 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1. Comparison between aCUP-E and liquid-gel electrodes | – | –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. |
| Cohort 2. Comparison between aCUP-E and needle electrodes | – | –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. |
| Cohort 3. Monitoring exclusively using aCUP-E | – | –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. |
Who may qualify
- Ages
- 26 to 41 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (3 listed)
- Preterm or term newborns admitted to the NICU who are at risk of encephalopathy due to conditions arising from the clinical context. For example, maternal infection (e.g. maternal infections such as fever during labour, urinary tract infection, etc.), maternal history of gestational diabetes, gestational hypertension or preeclampsia, history of delivery complications such as placental displacement or abnormal placentation.
- Informed consent obtained from the parents or legal guardians of the newborns.
- Availability of aEEG monitoring equipment and aCUP-E electrodes during the study period.
Key exclusion criteria (6 listed)
- Newborns with signs or symptoms of encephalopathy or any other evident neurological abnormality.
- Newborns with critical or unstable medical conditions that interfere with monitoring, such as the need for continuous mechanical ventilation or significant haemodynamic instability.
- Newborns receiving medication that may alter brain activity and interfere with aEEG results.
- Newborns with cranial or skin malformations that prevent proper electrode placement.
- Situations requiring urgent interventions that may interrupt monitoring or affect the quality of the data collected.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1. To compare the overall recording quality of aCUP-E with that of commercial electrodes.
Time frame: Through study completion, an average of 2 years
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
4 secondary outcomes
2. To evaluate the clinical feasibility of aCUP-E
Time frame: Through study completion, an average of 2 years
3. To evaluate the safety of aCUP-E
Time frame: Through study completion, an average of 2 years
4. To evaluate the reliability of aCUP-E recordings
Time frame: Through study completion, an average of 2 years
5. To evaluate electrode survival and durability
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vicenç Pascual, Clinical Neurophisyiologist contact
Questions about this trial
What is this clinical trial studying?
An observational study of Encephalopathy, run by Institut Investigacio Sanitaria Pere Virgili.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vicenç Pascual, Clinical Neurophisyiologist (34977 31 03 00 ext. 53160, vicenc.pascual@salutsantjoan.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. To compare the overall recording quality of aCUP-E with that of commercial electrodes. (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.