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
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