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NCT Number: NCT06857539

Assessing Intellectual and Motor Outcomes in High-risk Infants

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Palsy (CP) Cerebral Palsy Children Cerebrovascular Disorders Cognition Disorders Cognitive Development Cognitive Dysfunction Developmental Disabilities Female Urogenital Diseases and Pregnancy Complications HIE - Hypoxic - Ischemic Encephalopathy High-risk Infants Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Intellectual and Developmental Disabilities Mental Disorders Motor Impairment Nervous System Diseases Neurocognitive Disorders Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Prematurity; Extreme Preterm Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases Vascular Diseases

Age range

0 day–4 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Cork University Maternity Hospital, Cork, Ireland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. A

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

    To optimise existing predictive machine learning algorithms

  2. 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

  3. C

    Time frame: 18 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Clifford

CONTACT

[email protected]

+353 021 420 5082

Deirdre Murray Principal Investigator

CONTACT

[email protected]

+353 021 420 5082

Sponsors and collaborators

Lead sponsor

University College Cork

Other

Collaborators

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

Registry information

Official study title

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

Acronym: AIM-High

Important dates

Study start
2025
Primary completion
2030
Study completion
2030
First posted
Mar 4, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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