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RecruitingNCT06857539AIM-HighUpdated May 13, 2026

Assessing Intellectual and Motor Outcomes in High-risk Infants

An observational study in Cerebral Palsy, Cerebral Palsy (CP) and Cerebral Palsy Children, sponsored by University College Cork. Recruiting at 4 sites in Ireland. Open to participants aged 0 Days to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-13.

Sponsored by University College Cork · Observational

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
600
Ages
0 Days to 4 Months
Sex
All
01

Study summary

Cerebral palsy (CP) is a condition when a baby has a brain injury that affects their movement and muscle tone. Some people with CP can have other developmental issues, like learning impairments, but many do not and have isolated issues with their motor skills. Some newborns are at higher risk of developing CP, including babies born prematurely, those who have an injury to their brain, and those who have an abnormal neurological examination. However, most babies with a higher risk of CP do not develop CP. The problem is that doctors can't tell early on who will and who will not develop CP, they can only say who has a risk of it. Therefore, these babies are followed up in out-patient clinics to see how they are progressing, usually by a neonatologist (baby doctor), often a physiotherapist, and some may also be referred to services in the community like the Early Intervention Team. If there is a significant concern, doctors will often perform a scan of the baby's brain to provide more information. Even with all this follow-up, it still usually takes at least 12 months, and can be up to 2 years, to diagnose a child as having CP.

In this study the aim is to try and reduce the age of diagnosis of CP by assessing children in high-risk out-patient clinics using novel and specific examinations. We would also like to improve our ability to predict who will need help with learning, language or other non-motor outcomes. This study is being conducted at several hospitals in Ireland, including Cork University Maternity Hospital (CUMH), The Rotunda Hospital and the Coombe Women and Infants Hospital. It is being coordinated by the In4kids network and will be conducted in the INFANT Centre/ University College Cork (UCC). The study has been funded by Research Ireland and the Cerebral Palsy Foundation, USA.

02

Conditions studied

  • Cerebral Palsy
  • Cerebral Palsy (CP)
  • Cerebral Palsy Children
  • High-risk Infants
  • Intellectual and Developmental Disabilities
  • Motor Impairment
  • Cognitive Development
  • HIE - Hypoxic - Ischemic Encephalopathy
  • Preterm
  • Prematurity; Extreme

Keywords

  • Cerebral Palsy
  • High-Risk Infant Follow-up
  • Motor Difficulty
  • Intellectual Delay
  • Cognitive Impairment
  • Hypoxic--Ischaemic Encephalopathy
  • Prematurity
03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 600 is above the median of 63 across 472 observational studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

University College Cork is the lead sponsor of 119 studies on the registry; 25 are open to participants now.

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

04

Who can participate

Ages eligible
0 Days to 4 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically:

All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight

All encephalopathic infants

Neurological risk factors (e.g., injury/malformation on neuroimaging, persistently abnormal neurological exam)

All full-term infants (>37 weeks gestation), without requirement for admission to the NICU will be eligible to be enrolled in the study as the control arm of the 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

  • Legal guardians must be able and willing to give written and to comply with the requirements of this study protocol.
  • All infants considered high risk for a diagnosis of cerebral palsy and neuro-developmental impairment will be eligible, specifically including:

    • All preterm infants born ≤32 weeks Post Menstrual Age or ≤1500 gm birth weight
    • All encephalopathic infants
    • Neurological risk factors (e.g., cerebral birth defect, injury/malformation on neuroimaging, persistently abnormal neurological exam)

(Control Group)

-A control arm will also be recruited.

Exclusion criteria

Exclusion Criteria:

  • Death prior to discharge from the neonatal unit (High-Risk Infants only)
  • No parental consent (High-Risk and Control Infants)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
600 participants (estimated)
Target follow-up
30 Months
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • High-Risk Group

    This group will have risk factors such as prematurity or hypoxic-ischaemic encephalopathy which put them in the High-Risk cohort

  • Control Group

    This group will be healthy, term infants who do not require admission to neonatal intensive care

06

What researchers measure

Primary outcomes

  1. A

    To characterise the development of neural architecture and function during sleep using EEG, from the near-term period to 4 months corrected gestational age for infants at elevated risk of cerebral palsy and diagnosed with cerebral palsy

    Time frame: From near term to 4 months corrected gestational age

  2. B

    To examine underlying neuro-specific protein profiles near term corrected gestational age as early biomarkers of altered neural function, motor and developmental outcomes in infants at elevated risk of cerebral palsy and diagnosed with cerebral palsy.

    Time frame: Birth to 6 weeks

  3. C

    Develop novel measures of cognitive outcome, including executive function, and use these to compare trajectories in infants with cerebral palsy and those without, from 4 to 24 months

    Time frame: 4 to 24 months

Secondary outcomes

  1. A

    To optimise existing predictive machine learning algorithms

    Time frame: During the study period, ie. over five years

  2. B

    To develop and establish a standardised, early fixation classification assessment tool that can be used for infants at risk of cerebral palsy in high-risk follow-up clinics across Ireland

    Time frame: 4 months

  3. C

    To investigate ophthalmological biomarkers, including morphology, as potential early predictors of cerebral palsy and cognitive outcomes

    Time frame: 18 months

07

Study locations

3 of 4 sites recruiting
  • Cork University Maternity Hospital
    Cork, Ireland
    Recruiting
    • PI · Contactd.murray@ucc.ie · +353 (021) 420 5082
    • Andreea Pavel · Principal investigator
    • Brian H Walsh · Sub investigator
    • Caroline Aherne · Sub investigator
    • Eugene Dempsey · Sub investigator
    • Eamonn O'Connell · Sub investigator
  • INFANT Centre, University College Cork
    Cork, Ireland
    Recruiting
    • Jean Conway · Contactj.conway@ucc.ie · +353 021 420 5082
    • Geraldine Boylan · Principal investigator
    • Matilda Biba · Sub investigator
    • Danielle Clifford · Sub investigator
    • Mary Anne Ryan · Sub investigator
    • Sean Mathieson · Sub investigator
  • Coombe Women and Infant's Hospital
    Dublin, Ireland
    Not yet recruiting
    • PI · Contactd.murray@ucc.ie · +353 021 420 5082
    • Eleanor Molloy · Principal investigator
    • Denise McDonald · Principal investigator
  • The Rotunda Hospital
    Dublin, Ireland
    Recruiting
    • PI · Contactd.murray@ucc.ie · +353 021 420 5082
    • Breda Hayes · Principal investigator
    • Afif El-Khuffash · Principal investigator
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06857539
Collaborators
Coombe Women and Infants University Hospital, The Rotunda Hospital, Cerebral Palsy Foundation, Karolinska Institutet, University of Pisa, Göteborg University
Responsible party
Dr. Deirdre Murray (Professor of Paediatrics, University College Cork) — Principal investigator
First posted
Mar 4, 2025
Start date
Mar 21, 2025
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
May 13, 2026

Study contacts

Deirdre Murray Principal Investigator
Contact
d.murray@ucc.ie
+353 021 420 5082
Danielle Clifford
Contact
dclifford@ucc.ie
+353 021 420 5082
Deirdre M Murray
principal investigator · INFANT Research Centre, University College Cork, Cork, Ireland

Oversight

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

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