Clinical trial Recruiting at 3 sites Observational Ages 0 Days to 4 Months

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

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

Run by University College Cork · NCT06857539 · Data updated 2026-11-12

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 typeObservational
Ages0 Days to 4 Months
SexAll
Enrollment600 (estimated)
SponsorUniversity College Cork
Academic / other
Locations4 sites (Cork and 3 other locations)
StatusRecruiting
StartedMarch 21, 2025
Main results expectedJuly 31, 2030
Study endsJuly 31, 2030
Registry record updatedMay 13, 2026
Trial IDNCT06857539 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • Cork University Maternity Hospital
    Cork, Ireland
    Recruiting
  • INFANT Centre, University College Cork
    Cork, Ireland
    Recruiting
  • The Rotunda Hospital
    Dublin, Ireland
    Recruiting
  • Coombe Women and Infant's Hospital
    Dublin, Ireland
    Not yet recruiting

Study contacts

  • Principal investigator: Deirdre M Murray — INFANT Research Centre, University College Cork, Cork, Ireland
  • Study coordinator: Deirdre Murray Principal Investigator
  • Email: d.murray@ucc.ie
  • Phone: +353 021 420 5082

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.