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Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking

NCT07721155 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 93

Last updated 2026-07-22

No results posted yet for this study

Summary

Evidence indicates that Sickle Cell Disease (SCD) threatens neurodevelopmental outcome. Although children with SCD may be heterogeneously affected, neurocognitive impairment may already be present in toddlers. Neurocognitive functioning is an important determinant of adaptive daily life functioning later in life and is influenced by both the course of the disease and the often suboptimal environment in which afflicted children grow up. Early identification of children at the highest risk of neurocognitive impairment would enable the deployment of early interventions to mitigate the detrimental effects of SCD on the developing brain. In order to develop such interventions, a deeper understanding of the underlying pathophysiological mechanisms is required. Therefore the main aim is to study early neurocognitive functioning and development in children with SCD between the ages of 6 and 24 months old.

Conditions

Interventions

OTHER

eyetracking

Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.

DIAGNOSTIC_TEST

blood work

proteomics analyses methylation analyses

OTHER

Strengths and difficulties questionnaire (SDQ)

The strengths and difficulties questionnaire is a conventional instrument used to measure the presence of psychosocial problems, the child's strengths and the influence of psychosocial problems on daily functioning.

OTHER

TNO AZL Preschool Children Quality of Life (TAPQOL)

The TNO-AZL Preschool Children Quality of Life is a questionnaire that measures the health-related quality of life of children over the last three months

OTHER

Bayley Scale of Infant Development III (BSID)

The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Eligibility

Min Age
6 Months
Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-16
Primary Completion
2025-11-27
Completion
2025-12-02

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721155 on ClinicalTrials.gov