ClinicalTrials.gg
Enrolling by invitationNCT07880431AI4NICUUpdated Oct 19, 2026

Intelligent Physiological Monitoring to Predict Preterm Brain Injury

An observational study in Cerebral Palsy (CP), Intraventricular Hemorrhage Neonatal and Periventricular Leukomalacia, sponsored by University College Cork. Enrolling by invitation at 1 site in Ireland. Open to participants aged Up to 5 Days. Per ClinicalTrials.gov, last updated 2026-10-19.

Sponsored by University College Cork · Observational

Updated Oct 19, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
413
Ages
Up to 5 Days
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cerebral Palsy (CP)
  • Intraventricular Hemorrhage Neonatal
  • Periventricular Leukomalacia
  • Neurodevelopmental Delay

Keywords

  • artificial intelligence
  • neuromonitoring
  • electroencephalogram
  • near-infrared spectroscopy
03

In context

Cerebral Palsy

1,891 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.

This study's planned enrollment of 413 is above the median of 63 across 465 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University College Cork is the lead sponsor of 118 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 5 Days
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Congenital malformation or genetic syndrome.
  • Lack of parental consent for the original study data to be used for future related research.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
413 participants (estimated)
Patient registry
No

Groups and cohorts

  • Very Preterm Infants

    Very Preterm Infants that had early neuromonitoring

    Diagnostic Test: EEG · Diagnostic Test: NIRS

Interventions

  • Diagnostic testEEG

    During the first 72 hours after birth

  • Diagnostic testNIRS

    During the first 72 hours after birth

06

What researchers measure

Primary outcomes

  1. Early brain injury or death

    IVH, PVL or death

    Time frame: Within 36 weeks of gestation

  2. Cerebral palsy (CP)

    CP diagnosis

    Time frame: At 3 years

07

Study locations

1 site
  • University College Cork
    Cork, Cork P31RW84, Ireland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 19, 2026
Show all 1 update
  1. Oct 19, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07880431
Collaborators
Cerebral Palsy Foundation, Science Foundation Ireland
Responsible party
Gene Dempsey (Professor Eugene Dempsey Consultant Neonatologist, University College Cork) — Principal investigator
First posted
Oct 19, 2026
Start date
Apr 13, 2026
Primary completion
Dec 2027 (estimated)
Completion
Oct 2029 (estimated)
Last update
Oct 19, 2026

Study contacts

Eugene Dempsey, Professor
principal investigator · INFANT UCC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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