Cerebral Palsy (CP)AI4NICUNCT07880431
Intelligent Physiological Monitoring to Predict Preterm Brain Injury
An observational study of Cerebral Palsy (CP) and Intraventricular Hemorrhage Neonatal, run by University College Cork at 1 site in Ireland.
Trial summary
Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL) develop usually during the first few days after birth and are a strong predictor of CP. Read more about this study
- Who is it for?
- Ages Up to 5 days
- Conditions the study is for
- Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal, Periventricular Leukomalacia
- What is being tested?
- EEG and NIRS
- How many people
- 413 participants
- Where
- 1 siteIreland
- Study dates
- 13 Apr 2026to Oct 2029
- 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 Up to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with GA of 23 weeks 0 days to 31 weeks 6 days born between 01 JAN 2009 and 31 DEC 2021 and enrolled in any of the six previously collected INFANT study cohorts or in the University of Graz study.
Who may be able to join
- Neonates with GA of 23 weeks 0 days to 31 weeks 6 days born between 01 JAN 2009 and 31 DEC 2021 and enrolled in any of the six previously collected INFANT study cohorts or in the University of Graz study.
- Documented parental informed consent for the previously conducted study data to be used in the future for related research.
Who cannot join
- Congenital malformation or genetic syndrome.
- Lack of parental consent for the original study data to be used for future related research.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intelligent Physiological Monitoring of Preterm Infants to Predict Brain Injury Associated With CP and With Confirmed CP in the First Days After Birth
Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL) develop usually during the first few days after birth and are a strong predictor of CP. Development of IVH or PVL have been linked to hemodynamic instability. Artificial intelligence (AI) provides an opportunity to detect patterns from continuous physiological monitoring data that are associated with prematurity-related brain injury. A dataset of extremely preterm infants will be collated from previous INFANT Research Centre study cohorts. A separate but aligned anonymous dataset will be obtained from the University of Graz. Continuous physiological monitoring data will be analyzed with AI algorithms to identify infants with the highest risk of brain injury.
- Conditions
- Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal, Periventricular Leukomalacia, Neurodevelopmental Delay
- Being tested
- EEG, NIRS
- Keywords
- artificial intelligence, neuromonitoring, electroencephalogram, near-infrared spectroscopy
- Medical subject headings
- Cerebral Palsy, Leukomalacia, Periventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEGDiagnostic test
During the first 72 hours after birth
NIRSDiagnostic test
During the first 72 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| Very Preterm Infants | Very Preterm Infants that had early neuromonitoring Receives: Diagnostic Test: EEG; Diagnostic Test: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early brain injury or death
IVH, PVL or death
Measured: Within 36 weeks of gestation
Cerebral palsy (CP)
CP diagnosis
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start13 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies 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
- Retrospective
- Enrolment
- 413 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Cerebral Palsy Foundation, Science Foundation Ireland
- Responsible party
- Principal investigator, Gene Dempsey, University College Cork
- Investigators
- Eugene Dempsey, Professor, Principal investigator, INFANT UCC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880431
- Sponsor's protocol ID
- ECM 4 (gg) 03/02/2026
- Acronym
- AI4NICU
- Status last verified
- Aug 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Physiological Monitoring of Preterm Infants to Predict Brain Injury Associated With CP and With Confirmed CP in the First Days After Birth
- ClinicalTrials.gov ID
- NCT07880431
- Acronym / sponsor ID
- AI4NICU / ECM 4 (gg) 03/02/2026
- Conditions
- Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal, Periventricular Leukomalacia, Neurodevelopmental Delay
- Keywords
- artificial intelligence, neuromonitoring, electroencephalogram, near-infrared spectroscopy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 413 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Cerebral Palsy Foundation, Science Foundation Ireland
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 19 Oct 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.
Cerebral palsy (CP) remains prevalent among very (28-31 weeks) and extremely (<28 weeks) preterm infants. Prematurity-related brain injuries (high-grade intraventricular haemorrhage, IVH or periventricular leukomalacia, PVL) develop usually during the first few days after birth and are a strong predictor of CP. Development of IVH or PVL have been linked to hemodynamic instability. Artificial intelligence (AI) provides an opportunity to detect patterns from continuous physiological monitoring data that are associated with prematurity-related brain injury. A dataset of extremely preterm infants will be collated from previous INFANT Research Centre study cohorts. A separate but aligned anonymous dataset will be obtained from the University of Graz. Continuous physiological monitoring data will be analyzed with AI algorithms to identify infants with the highest risk of brain injury.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Very Preterm Infants | – | Diagnostic Test: EEG, Diagnostic Test: NIRSVery Preterm Infants that had early neuromonitoring |
Who may qualify
- Ages
- Up to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with GA of 23 weeks 0 days to 31 weeks 6 days born between 01 JAN 2009 and 31 DEC 2021 and enrolled in any of the six previously collected INFANT study cohorts or in the University of Graz study.
Key inclusion criteria (2 listed)
- Neonates with GA of 23 weeks 0 days to 31 weeks 6 days born between 01 JAN 2009 and 31 DEC 2021 and enrolled in any of the six previously collected INFANT study cohorts or in the University of Graz study.
- Documented parental informed consent for the previously conducted study data to be used in the future for related research.
Key exclusion criteria (2 listed)
- Congenital malformation or genetic syndrome.
- Lack of parental consent for the original study data to be used for future related research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EEGDuring the first 72 hours after birth | Diagnostic test | Very Preterm Infants |
| NIRSDuring the first 72 hours after birth | Diagnostic test | Very Preterm Infants |
Primary outcome
Early brain injury or death
Time frame: Within 36 weeks of gestation
IVH, PVL or death
Cerebral palsy (CP)
Time frame: At 3 years
CP diagnosis
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 19 Oct 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.
Eugene Dempsey, Professor principal investigator
INFANT UCC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy (CP) and Intraventricular Hemorrhage Neonatal, run by University College Cork at 1 site in Ireland.
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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early brain injury or death (time frame: Within 36 weeks of gestation). The study lists 2 primary outcomes in all. 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 19 Oct 2026.