Assessing Intellectual and Motor Outcomes in High-risk Infants (AIM-High)

May 8, 2026 updated by: Dr. Deirdre Murray, University College Cork

The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Deirdre Murray Principal Investigator
  • Phone Number: +353 021 420 5082
  • Email: d.murray@ucc.ie

Study Contact Backup

  • Name: Danielle Clifford
  • Phone Number: +353 021 420 5082
  • Email: dclifford@ucc.ie

Study Locations

  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Maternity Hospital
        • Contact:
        • Principal Investigator:
          • Andreea Pavel
        • Sub-Investigator:
          • Brian H Walsh
        • Sub-Investigator:
          • Caroline Aherne
        • Sub-Investigator:
          • Eugene Dempsey
        • Sub-Investigator:
          • Eamonn O'Connell
      • Cork, Ireland
        • Recruiting
        • INFANT Centre, University College Cork
        • Contact:
        • Principal Investigator:
          • Geraldine Boylan
        • Sub-Investigator:
          • Matilda Biba
        • Sub-Investigator:
          • Danielle Clifford
        • Sub-Investigator:
          • Mary Anne Ryan
        • Sub-Investigator:
          • Sean Mathieson
      • Dublin, Ireland
        • Recruiting
        • The Rotunda Hospital
        • Contact:
        • Principal Investigator:
          • Breda Hayes
        • Principal Investigator:
          • Afif El-Khuffash
      • Dublin, Ireland
        • Not yet recruiting
        • Coombe Women and Infant's Hospital
        • Contact:
        • Principal Investigator:
          • Eleanor Molloy
        • Principal Investigator:
          • Denise McDonald

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

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

Description

Inclusion Criteria (High Risk Group) :

  • Legal guardians must be able and willing to give written informed consent 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:

  • Death prior to discharge from the neonatal unit (High-Risk Infants only)
  • No parental consent (High-Risk and Control Infants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A
Time Frame: From near term to 4 months corrected gestational age
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
From near term to 4 months corrected gestational age
B
Time Frame: Birth to 6 weeks
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.
Birth to 6 weeks
C
Time Frame: 4 to 24 months
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
4 to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A
Time Frame: During the study period, ie. over five years
To optimise existing predictive machine learning algorithms
During the study period, ie. over five years
B
Time Frame: 4 months
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
4 months
C
Time Frame: 18 months
To investigate ophthalmological biomarkers, including morphology, as potential early predictors of cerebral palsy and cognitive outcomes
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College Cork

Collaborators

Karolinska Institutet
University of Pisa
Göteborg University
The Rotunda Hospital
Coombe Women and Infants University Hospital
Cerebral Palsy Foundation

Investigators

  • Principal Investigator: Deirdre M Murray, INFANT Research Centre, University College Cork, Cork, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

December 5, 2024

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Patient Data may not be shared according to ethical approval

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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