Assessing Intellectual and Motor Outcomes in High-risk Infants

NCT06857539 | Not Yet Recruiting

• 1 other identifier: DM01
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 4

Brief 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. 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. 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 Science Foundation Ireland (SFI) and the Cerebral Palsy Foundation, USA.

Conditions

Cerebral Palsy; Cerebral Palsy (CP); Cerebral Palsy Children; High-risk Infants; Intellectual and Developmental Disabilities; Motor Impairment; Cognitive Development

Keywords

Cerebral Palsy; High-Risk Infant Follow-up; Motor Difficulty; Intellectual Delay; Cognitive Impairment

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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

  4 to 24 months

Secondary Outcomes (3)

• A

  During the study period, ie. over five years

• B

  4 months

• C

  18 months

Study Arms (2)

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

Eligibility Criteria

• Age: 0 Days - 4 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• \- (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)
• All full term infants will be eligible if:
• Term infants born \> 37 weeks gestational age
• Not admitted to the NICU
• No neurological impairments at birth (no identified congenital or genetic abnormalities)

You may not qualify if:

• \- (High Risk \& Control Groups)
• Death prior to discharge from the neonatal unit (High-Risk Infants only)
• No parental consent (High-Risk and Control Infants)

Sponsors & Collaborators

• University College Cork: lead
• Coombe Women and Infants University Hospital: collaborator
• The Rotunda Hospital: collaborator
• Cerebral Palsy Foundation: collaborator
• Karolinska Institutet: collaborator
• University of Pisa: collaborator
• Göteborg University: collaborator

Study Sites (4)

Cork University Maternity Hospital

Cork, Ireland

Location

INFANT Centre, University College Cork

Cork, Ireland

Location

Coombe Women and Infant's Hospital

Dublin, Ireland

Location

The Rotunda Hospital

Dublin, Ireland

Location

Related Links

• Launch of Cerebral Palsy Research Programme at University College Cork
• Inaugural lecture: Professor Deirdre Murray, CPF Chair in Early Brain Injury and Cerebral Palsy

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microsampling will be used to collect samples from high-risk infants in the neonatal unit. These will be used for biomarker analysis including neurospecific proteins and mRNA.

MeSH Terms

Conditions

Cerebral Palsy; Developmental Disabilities; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Study Officials

• Deirdre M Murray

  INFANT Research Centre, University College Cork, Cork, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deirdre Murray Principal Investigator

CONTACT

+353 021 420 5082; d.murray@ucc.ie

Danielle Clifford

CONTACT

+353 021 420 5082; dclifford@ucc.ie

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Paediatrics

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: March 4, 2025
• Study Start: March 4, 2025
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (4)