Trials / Completed
CompletedNCT03660774
A Study of the Impact of Hemophilia and Its Treatment on Brain Development, Thinking and Behaviour in Children With Hemophilia
Evolving Treatment of Hemophilia's Impact on Neurodevelopment, Intelligence and Other Cognitive Functions (eTHINK)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 563 (actual)
- Sponsor
- Novo Nordisk A/S · Industry
- Sex
- Male
- Age
- 1 Year – 21 Years
- Healthy volunteers
- Not accepted
Summary
The Hemophilia Growth and Development Study (HGDS) nearly 25 years ago showed haemophilia and HIV impacted brain development, thinking, and behaviour in children and adolescents. The eTHINK study is designed to understand whether advances in hemophilia treatment have removed any impact of hemophilia. If there still is an impact of hemophilia, the eTHINK study will help to identify which children or adolescents are still at risk, and how to screen other children. Participants and their child will participate in a comprehensive assessment of child's brain development, thinking and behavior through completing tests and questionnaires. There is only one study visit of 1 to 1.5 hours with no follow-up required
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No treatment given | The participants will undergo a brief physical examination focused on neurologic function (muscle function, sensation, coordination, walking). Parents will be asked by the study team or the psychologist about their children and will complete several commonly used standard surveys about brain development, thinking, behavior, and decision making. The participants will also engage with the psychologist to evaluate development or thinking (IQ), and depending on their age they may be asked to complete one or more commonly used standard surveys about behavior and decision making. |
Timeline
- Start date
- 2018-09-27
- Primary completion
- 2019-10-11
- Completion
- 2019-10-11
- First posted
- 2018-09-07
- Last updated
- 2019-11-22
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03660774. Inclusion in this directory is not an endorsement.