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. (aCUP HUSJR/J23)
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.
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.
Descripción general del estudio
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Estudio Contacto
- Nombre: Vicenç Pascual, Clinical Neurophisyiologist
- Número de teléfono: 53160 34977 31 03 00
- Correo electrónico: vicenc.pascual@salutsantjoan.cat
Criterios de participación
Criterio de elegibilidad
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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.
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
Cohortes e Intervenciones
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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. |
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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. |
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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. |
¿Qué mide el estudio?
Medidas de resultado primarias
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1. To compare the overall recording quality of aCUP-E with that of commercial electrodes.
Periodo de tiempo: Through study completion, an average of 2 years
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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 |
Through study completion, an average of 2 years
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Medidas de resultado secundarias
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2. To evaluate the clinical feasibility of aCUP-E
Periodo de tiempo: Through study completion, an average of 2 years
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This outcome will evaluate the clinical feasibility in relation with standard practice. The outcome will be the results of a survey from clinicians. |
Through study completion, an average of 2 years
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3. To evaluate the safety of aCUP-E
Periodo de tiempo: Through study completion, an average of 2 years
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This outcome will evaluate the safety of the electrode. The outcome will be the results of a survey from clinicians. |
Through study completion, an average of 2 years
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4. To evaluate the reliability of aCUP-E recordings
Periodo de tiempo: Through study completion, an average of 2 years
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This outcome will evaluate the differences between recordings. The outcome will be the % of differences between recordings. |
Through study completion, an average of 2 years
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5. To evaluate electrode survival and durability
Periodo de tiempo: Through study completion, an average of 2 years
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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. |
Through study completion, an average of 2 years
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Colaboradores e Investigadores
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Última actualización enviada que cumplió con los criterios de control de calidad
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Más información
Términos relacionados con este estudio
Palabras clave
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Otros números de identificación del estudio
Otros números de identificación del estudio
- 196/2025
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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