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NCT03023644 · ClinicalTrials.gov registry record · NA
Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study
A NA study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- NA
- Development phase
- 106
- Enrollment target
NCT03023644 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 106 participants.
The verdict
NCT03023644, a NA study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 106 participants
- Enrollment target
Study Summary
Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. These survivors face challenges in terms of their cognitive and behavioral development. For many, the limitations affect their academic achievement, social adaption and, ultimately, their quality of life. Among the most disabling limitations are those that pertain to the ability to maintain attention, plan and organize activities, regulate emotions, and develop problem-solving strategies. Collectively, these are referred to as executive functions (EF) because they are higher-order abilities that enable one to coordinate complex behaviors. Additionally, impaired EF also underlie mental health disorders. In spite of the abundance of evidence that children with CHD struggle with EF, there is little to offer them in the way of evidence-based interventions to prevent or mitigate these problems. The investigators propose to conduct the first randomized trial to evaluate the efficacy of an intervention, the Cogmed Working Memory Program, in improving the neurodevelopment outcomes of children with critical CHD after infant open-heart surgery. Children who meet eligibility criteria and who agree to participate will be randomly assigned to an intervention or control group. Children in the intervention group will complete 25 35-40 minute sessions of Cogmed training, spread over for 5 weeks. This Program is a set of home-based, child-friendly, computerized activities. The control group will receive the standard of care for children with CHD. Children's scores on EF and related neurodevelopmental tests will be evaluated before the intervention group completes Cogmed training, at the conclusion of their training, and 3 months later. The latter assessment will indicate whether any gains in EF skills of t
Interventions
- BEHAVIORAL Cogmed Working Memory Training
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2017-02-21 |
| Est. Completion | 2020-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03023644
The ClinicalTrials.gov registry entry for NCT03023644 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cogmed Working Memory Training is the first listed.
NCT03023644 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03023644 about?
NCT03023644 is a clinical study titled "Improving Neurodevelopmental Outcomes in Children With Congenital Heart Disease: An Intervention Study". Each year, approximately 1 child in every 100 is born with Congenital Heart Disease (CHD), making it the most common birth defect. With recent medical advances, more children with CHD survive early open-heart surgery, so that there are now 2 to 3 million adult survivors with CHD. These survivors fac...
What is the current status of trial NCT03023644?
This trial is currently completed. It is a NA study. The enrollment target is 106 participants. The study started on 2017-02-21. Estimated completion is 2020-09-30.
What interventions are being tested in trial NCT03023644?
The interventions under investigation include: Cogmed Working Memory Training (BEHAVIORAL).
Who is sponsoring clinical trial NCT03023644?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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