Tracking intellectual and motor development in babies at high risk for cerebral palsy

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

This project will follow babies at higher risk for cerebral palsy to see if early thinking and movement signs predict later intellectual and motor outcomes.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 0 Days to 4 Months
• Sex: All
• Sponsor: University College Cork (Academic / other)
• Locations: 4 sites (Cork and 3 other locations)
• Trial ID: NCT06857539 on ClinicalTrials.gov

What this trial studies

This observational follow-up enrolls infants considered at high risk for cerebral palsy alongside a control group and tracks their motor and cognitive development over time. High-risk enrollment includes infants born ≤32 weeks or ≤1500 g, infants with encephalopathy, or those with abnormal neurological exams or neuroimaging findings. Care teams including neonatologists and physiotherapists perform standardized clinical exams, and brain scans are used when concerns arise, with progress documented in outpatient clinics and community early intervention referrals made as needed. Data will be analyzed to identify early signs that predict later intellectual and motor outcomes.

Who should consider this trial

Good fit: Infants who are deemed high risk for cerebral palsy—such as those born ≤32 weeks or ≤1500 g, encephalopathic infants, or those with abnormal neuroimaging or persistent abnormal exams—whose legal guardians can give consent, plus a recruited control group.

Not a fit: Infants who die before discharge or whose parents do not consent cannot participate and will not benefit, and babies without high-risk features or with already established outcomes are less likely to gain from enrollment.

Why it matters

Potential benefit: If successful, clinicians could identify high-risk babies who need early therapies sooner, potentially improving long-term learning and movement outcomes.

How similar studies have performed: Previous longitudinal follow-up and neonatal imaging studies have shown some predictive value for later cerebral palsy and developmental delays but prediction remains imperfect, so this study builds on existing evidence.

Eligibility criteria

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)

Where this trial is running

Cork and 3 other locations

• Cork University Maternity Hospital — Cork, Ireland (Recruiting)
• INFANT Centre, University College Cork — Cork, Ireland (Recruiting)
• Coombe Women and Infant's Hospital — Dublin, Ireland (Not_yet_recruiting)
• The Rotunda Hospital — Dublin, Ireland (Recruiting)

Study contacts

• Principal investigator: Deirdre M Murray — INFANT Research Centre, University College Cork, Cork, Ireland
• Study coordinator: Deirdre Murray Principal Investigator

Conditions Cerebral Palsy; Cerebral Palsy Children; High-risk Infants; Intellectual and Developmental Disabilities; Motor Impairment; Cognitive Development; HIE - Hypoxic - Ischemic Encephalopathy; Preterm