This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete virtual game and assessments. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home. All study visits will take place online via Zoom.
Who can participate
Age range
3 Months – 24 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Child-parent dyads will be recruited to the study.
* Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.
* Children with PBIs will include:
* Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,
* Children born at a premature gestational age (born at less than 32 weeks gestational age).
* Children diagnosed with cerebral palsy
* Healthy control participants meeting inclusion criteria will include:
* healthy infants with no prior neurological (brain disorder) history
* For all parents: the only research inclusion criteria is to be the parent or legal guardian of a newborn with perinatal brain injury or healthy control participant.
Exclusion Criteria:
* Healthy infants to be included in the control group will not have:
* a prior history of brain injury
* a diagnosis of cerebral palsy
* a history of a neurological disorder
* prior admission to the Neonatal Intensive Care Unit (NICU)
* Children with chromosomal abnormalities, genetic syndromes and major congenital malformations will be excluded from both the patient groups and the control group.
* Parents will have no exclusionary criteria.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Infant Attention Task (IAT)
Timeframe: Assessed at the 12,18, and 24-month time points
2
Cognitive Adaptive Test/Clinical Linguistic & Auditory Milestone Scale (CAPUTE)
Timeframe: Assessed at the 6 and 12-month time points