Cerebral PalsyAIM-HighNCT06857539
Assessing Intellectual and Motor Outcomes in High-risk Infants
An observational study of Cerebral Palsy and Cerebral Palsy (CP), run by University College Cork at 4 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 days to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children
- How many people
- 600 participants
- Where
- 4 sitesIreland
- Study dates
- 21 Mar 2025to 31 Jul 2030
- How long will I take part?
- 30 Months
- 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 0 days to 4 months
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- 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.
Who cannot join
- Death prior to discharge from the neonatal unit (High-Risk Infants only)
- No parental consent (High-Risk and Control Infants)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland4 sites, 4 recruiting
- Recruiting
Cork University Maternity Hospital
Cork
PI, +353 (021) 420 5082, d.murray@ucc.ie
Andreea Pavel
- Recruiting
INFANT Centre, University College Cork
Cork
Jean Conway, +353 021 420 5082, j.conway@ucc.ie
Geraldine Boylan
- Not yet recruiting
Coombe Women and Infant's Hospital
Dublin
PI, +353 021 420 5082, d.murray@ucc.ie
Eleanor Molloy
- Recruiting
The Rotunda Hospital
Dublin
PI, +353 021 420 5082, d.murray@ucc.ie
Breda Hayes
About this study
Official title: 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.
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants, Intellectual and Developmental Disabilities, Motor Impairment
- Keywords
- Cerebral Palsy, High-Risk Infant Follow-up, Motor Difficulty, Intellectual Delay, Cognitive Impairment, Hypoxic--Ischaemic Encephalopathy, Prematurity
- Medical subject headings
- Cerebral Palsy, Developmental Disabilities, Premature Birth, Cognitive Dysfunction, Hypoxia-Ischemia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From near term to 4 months corrected gestational age
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.
Measured: Birth to 6 weeks
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
Measured: 4 to 24 months
Secondary outcomes (3)
A
To optimise existing predictive machine learning algorithms
Measured: During the study period, ie. over five years
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
Measured: 4 months
C
To investigate ophthalmological biomarkers, including morphology, as potential early predictors of cerebral palsy and cognitive outcomes
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start21 Mar 2025
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 30 Months
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Collaborators
- Coombe Women and Infants University Hospital, The Rotunda Hospital, Cerebral Palsy Foundation, Karolinska Institutet, University of Pisa, Göteborg University
- Responsible party
- Principal investigator, Dr. Deirdre Murray, University College Cork
- Investigators
- Deirdre M Murray, Principal investigator, INFANT Research Centre, University College Cork, Cork, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857539
- Sponsor's protocol ID
- DM01
- Acronym
- AIM-High
- Status last verified
- May 2026
- First submitted
- 5 Dec 2024
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Patient Data may not be shared according to ethical approval
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ELEVATE Program for Prediction, Early Detection & Intervention in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06857539
- Acronym / sponsor ID
- AIM-High / DM01
- Conditions
- Cerebral Palsy, Cerebral Palsy (CP), Cerebral Palsy Children, High-risk Infants, Intellectual and Developmental Disabilities, Motor Impairment
- Keywords
- Cerebral Palsy, High-Risk Infant Follow-up, Motor Difficulty, Intellectual Delay, Cognitive Impairment, Hypoxic--Ischaemic Encephalopathy, Prematurity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Collaborators
- Coombe Women and Infants University Hospital, The Rotunda Hospital, Cerebral Palsy Foundation, Karolinska Institutet, University of Pisa, Göteborg University
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 4 Mar 2025 (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) 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 30 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 days to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (7 listed)
- 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:
- (Control Group)
- -A control arm will also be recruited.
Key exclusion criteria (2 listed)
- Death prior to discharge from the neonatal unit (High-Risk Infants only)
- No parental consent (High-Risk and Control Infants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
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
3 secondary outcomes
A
Time frame: During the study period, ie. over five years
B
Time frame: 4 months
C
Time frame: 18 months
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 13 May 2026.
- Launch of Cerebral Palsy Research Programme at University College CorkLink provided by the sponsor.
- Inaugural lecture: Professor Deirdre Murray, CPF Chair in Early Brain Injury and Cerebral PalsyLink provided by the sponsor.
- Cerebral Palsy advocate Lily Collison receives honorary doctorate from UCCLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Patient Data may not be shared according to ethical approval
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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.
Deirdre M Murray principal investigator
INFANT Research Centre, University College Cork, Cork, Ireland
4 sites 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 and Cerebral Palsy (CP), run by University College Cork at 4 sites 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 7 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: looking for participants now, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Contact Deirdre Murray Principal Investigator (+353 021 420 5082, d.murray@ucc.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A (time frame: From near term to 4 months corrected gestational age). The study lists 3 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 13 May 2026.