Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Injuries Seizures Newborn

Outcome Measures

Primary Outcomes (1)

Assessing whether an acceptable EEG recording can be attained for the device on the first attempt for 80% of attempted recordings
Feasibility of the device is achieved if a good quality recording on the first attempt is achieved in at least 80% of infants , i.e. the device is not feasible if the success rate is \<80%. Acceptable EEG in terms of technical quality for satisfactory review: * The recording should clearly be recording brain activity; if an electrode is poorly attached or detached, the EEG channel is likely to show continuous high amplitude/chaotic artifact which is not acceptable. * The brain activity for a term baby should contain continuous activity of mixed frequency content (delta, theta, alpha activity) with amplitudes ranging from 25-150µV. * The EEG should not be marred by persistent 50Hz due to high electrode impedance, that makes the recording unreadable. A 'majority' (50%+) of the EEG should be artefact free and readable.
Day 1

Secondary Outcomes (4)

Time taken to complete assessment (as above) when a good quality recording is obtained for an infant on the first attempt
Day 1
Time taken to complete assessment (as above) when a good quality recording is NOT obtained for an infant on the first attempt.
Day 1
Number of attempts by a user before a good quality recording is achieved (Max 3 attempts)
Day 1
Assessment of healthcare satisfaction with useability of the device and procedure derived from data captured during recordings and interviews.
The interviews will be conducted with the researchers after 10 weeks, after 20 weeks and at the end of the study - up to 30 weeks

Study Arms (2)

Neonatal Intensive care Unit

50% of the babies recruited will be from the Neonatal Intensive Care Unit. All term neonates ≥ 37 and ≤ 45 weeks corrected gestation age are eligible for the NBT study that do not have head trauma or broken skin on the scalp.

Device: Cergenx Wave

Post Natal Ward

50% of the babies recruited will be from the Post Natal Ward. All term neonates ≥ 37 and ≤ 45 weeks corrected gestation age are eligible for the NBT study that do not have head trauma or broken skin on the scalp.

Device: Cergenx Wave

Interventions

Cergenx WaveDevice

Short EEG recording using EEG amplifier with cloud based algorithm to assess brain injury.

Neonatal Intensive care UnitPost Natal Ward

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age37 Weeks - 45 Weeks

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17)

Sampling MethodNon-Probability Sample

Study Population

90 babies will be recruited in total that meet the inclusion criteria above. 45 will be from the Neonatal Intensive care Unit and 45 from the Post natal Ward

You may qualify if:

All neonates≥ 37 and ≤45 weeks gestational age

Sponsors & Collaborators

Professor Geraldine Boylan
Otherlead

Study Sites (1)

Cork University Maternity Hospital

Cork, T12 YE02, Ireland

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

Geraldine Boylan, Professor
University College Cork INFANT Centre
STUDY DIRECTOR

Enrollment

93 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: OTHER
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

July 24, 2024

First Posted

August 30, 2024

Study Start

July 22, 2024

Actual (reported)

Newborn Brain Test (NBT)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Neonatal Intensive care Unit

Post Natal Ward

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

Neonatal Intensive care Unit

Post Natal Ward

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations