Actively Recruiting

Age: 0Days - 4Months
All Genders
Healthy Volunteers
ID06857539

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

Led by University College Cork · Updated on 2026-05-13

600

Participants Needed

4

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University College Cork

Lead Sponsor

C

Coombe Women and Infants University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Cerebral palsy (CP) is a condition caused by brain injury in babies that affects movement and muscle tone. Some children with CP may have other developmental challenges like learning difficulties, but many have mostly motor skill issues. This study aims to reduce the age at which CP is diagnosed by using new and specific assessments in high-risk infants, such as those born prematurely or with brain injuries. It also seeks to better predict which children might need support for learning, language, or other developmental outcomes. The research is coordinated by University College Cork and supported by Research Ireland and the Cerebral Palsy Foundation, USA. The study compares two groups: a high-risk group of infants with factors like prematurity or hypoxic-ischaemic encephalopathy, and a control group of healthy term infants who did not require neonatal intensive care. Participants will be assessed in outpatient clinics using novel examinations to track their development. The study will take place at multiple hospitals in Ireland and will monitor infants from near term up to 24 months corrected gestational age. During the study, infants will have regular assessments at various time points, including near term to 4 months corrected gestational age, birth to 6 weeks, and 4 to 24 months. Researchers will evaluate motor and intellectual outcomes over a five-year period with follow-ups at 4 and 18 months. Guardians will provide consent and comply with study requirements, and the team will observe the infants' progress to better understand early signs of CP and developmental impairments.

CONDITIONS

Brief Title

Assessing Intellectual and Motor Outcomes in High-risk Infants

Who Can Participate

Age: 0Days - 4Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Legal guardians must be able and willing to give written informed consent and comply with the study protocol
  • Infants considered high risk for cerebral palsy and neuro-developmental impairment
  • Preterm infants born at or before 32 weeks post menstrual age or weighing 1500 grams or less
  • Encephalopathic infants
  • Infants with neurological risk factors such as cerebral birth defects, injury or malformation on neuroimaging, or persistently abnormal neurological exam
  • Control group includes healthy term infants not requiring neonatal intensive care
Not Eligible

You will not qualify if you...

  • Death prior to discharge from the neonatal unit (for high-risk infants only)
  • No parental consent (for both high-risk and control infants)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 5 years

Participants are observed over time to assess intellectual and motor outcomes.

Multiple visits over 5 years depending on individual risk factors

Trial Site Locations

Total: 4 locations

1

Cork University Maternity Hospital

Cork, Ireland

Actively Recruiting

2

INFANT Centre, University College Cork

Cork, Ireland

Actively Recruiting

3

Coombe Women and Infant's Hospital

Dublin, Ireland

Not Yet Recruiting

4

The Rotunda Hospital

Dublin, Ireland

Actively Recruiting

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Research Team

D

Deirdre Murray Principal Investigator

D

Danielle Clifford

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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