Sickle Cell DiseaseONSETNCT07721155
Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking
An observational study of Sickle Cell Disease and Sickle Cell, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell, Neurocognition, Child
- What is being tested?
- eyetracking, blood work and Strengths and difficulties questionnaire (SDQ)
- How many people
- 93 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Mar 2023to 2 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children between the 6 and 24 months are invited to participate in the study.
Who may be able to join
- Age 6 - 24 months old
- Inhabitant of the Netherlands
- Written informed consent from parent/caretaker.
Who cannot join
- Refused informed consent from parents/care-taker
- Diagnosis of visual impairment (which cannot be corrected by glasses)
- Diagnosis of a (co-morbid) congenital developmental condition
- Any neurological condition, unrelated to SCD, that could affect the central nervous system, such as brain trauma, epilepsy and meningitis/encephalitis.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objective: The main aim is to study early neurocognitive functioning and development in very young children with SCD. The secondary aims are to 1) (i) identify demographic, psychosocial and clinical determinants and (ii) identify biomarkers associated with early neurocognitive deficits in young children with SCD. 2) Analyze the association between early neurocognitive functioning and adaptive daily life functioning.
Study design: Prospective observational study with an accelerated longitudinal design. The accelerated longitudinal design allows for the inclusion of children from a broad age range (6 - 24 months). During the total study period of 30 months, children can enroll in the study at the ages of 6, 12, 18 and 24 months. After enrollment, children will visit every 6 months until they reach the age of 24 months. This design spans the age range of interest in a shorter period of time and a smaller load on participants as compared to a conventional longitudinal design.
Methods: Eye-tracking measurements will take place at every study visit. Demographic, psychosocial and clinical characteristics of the SCD group will be collected using prospective and structured clinical registration as part of regular clinical care. Demographic, psychosocial and clinical information of the control group will be collected using a parent questionnaire administered during the first and last study visit. Blood samples of children with SCD will be taken as part of regular blood checks at the age of 12 and/or 24 months (depending on the age of enrollment in the study). The Child Behavior Checklist, TNO AZL Preschool Children Quality of Life and the Bayley Scale of Infant and Child Development will be administered to all children at the age of 24 months.
Main study parameters/endpoints: Neurocognitive functioning, as measured using eye-tracking.
Secondary study parameters/ endpoints: The following determinants will be measured: Demographic, psychosocial and clinical characteristics, as measured as part of regular clinical care (SCD group) or via parent questionnaire (control group) and Biomarkers, as measured in blood (SCD group). Adaptive daily life functioning, as measured by quality of life, behavioural and emotional functioning questionnaire, and general (cognitive) development assessment.
- Conditions
- Sickle Cell Disease, Sickle Cell, Neurocognition, Child
- Being tested
- eyetracking, blood work, Strengths and difficulties questionnaire (SDQ), TNO AZL Preschool Children Quality of Life (TAPQOL), Bayley Scale of Infant Development III (BSID)
- Keywords
- sickle cell, cognition
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eyetrackingOther
Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
blood workDiagnostic test
proteomics analyses methylation analyses
Strengths and difficulties questionnaire (SDQ)Other
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.
TNO AZL Preschool Children Quality of Life (TAPQOL)Other
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
Bayley Scale of Infant Development III (BSID)Other
The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Infants between 6 and 24 months of age diagnosed with sickle cell disease Receives: Other: eyetracking; Diagnostic Test: blood work; Other: Strengths and difficulties questionnaire (SDQ); Other: TNO AZL Preschool Children Quality of Life (TAPQOL); Other: Bayley Scale of Infant Development III (BSID) | |
| Healthy subject group | Infants between 6 and 24 months of age without sickle cell disease Receives: Other: eyetracking; Other: Strengths and difficulties questionnaire (SDQ); Other: TNO AZL Preschool Children Quality of Life (TAPQOL); Other: Bayley Scale of Infant Development III (BSID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing speed in the gap condition (Gap/Overlap task)
The speed of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as reaction time (RT) via eye-tracking in infants with sickle cell disease (SCD). Unit of Measure: Milliseconds (ms)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Processing accuracy in the gap condition (Gap/Overlap task)
The precision of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD.
Unit of Measure: Proportion of accurate trials
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Orienting attention speed in the overlap condition (Gap/Overlap task)
The speed of orienting attention away from a central stimulus toward a peripheral target when the central stimulus remains on screen. Measured as RT in the overlap condition expressed as percentage change relative to mean RT in the gap condition, via eye-tracking in infants with SCD.
Unit of Measure: Percentage (%)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Orienting attention accuracy in the overlap condition (Gap/Overlap task)
The precision of orienting attention toward a peripheral target when the central stimulus remains on screen. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD.
Unit of Measure: Proportion of accurate trials
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Alerting attention without external cues (Gap/Overlap task)
The ability to maintain focus on the task without external attention-grabbing cues. Measured as a binomial outcome per trial (completed without attention grabber: yes/no) via eye-tracking in infants with SCD.
Unit of Measure: Proportion of trials completed without attention grabber
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Sustained attention across trials (Gap/Overlap task)
The ability to attend to the task over a longer period. Measured as the number of trials completed expressed as a percentage of the total possible trials, via eye-tracking in infants with SCD.
Unit of Measure: Percentage (%)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Fixation duration during free viewing (Freeview task)
The amount of time the eyes remain stably focused on a specific location, defined as periods of stable gaze between successive saccades. Measured as mean fixation duration via eye-tracking in infants with SCD.
Unit of Measure: Milliseconds (ms)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Habituation (Habituation task)
The process of becoming accustomed to a repeatedly presented stimulus. Measured as the number of trials required to reach the pre-defined habituation criterion via eye-tracking in infants with SCD.
Unit of Measure: Number of trials
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Recognition (Habituation task)
The ability to distinguish a previously presented stimulus from a novel one. Measured as the absolute difference in looking time toward the habituation stimulus versus the novel stimulus, via eye-tracking in infants with SCD.
Unit of Measure: Percentage (%)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Novelty preference (Habituation task)
The tendency to inspect a novel stimulus relative to a previously presented one. Measured as looking time toward the novel stimulus as a percentage of total looking time, via eye-tracking in infants with SCD.
Unit of Measure: Percentage (%)
Measured: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
Secondary outcomes (4)
Demographic and perinatal characteristics assessed via parent-reported questionnaire
Demographic and perinatal information collected via a structured parent/caretaker questionnaire, including child age, sex, ethnicity, country of origin, parental education level (as proxy for socioeconomic status), and perinatal information (e.g. breastfeeding, birth characteristics). Clinical characteristics (e.g. SCD genotype, disease severity, treatment) are extracted from electronic health records.
Unit of Measure: Categorical and continuous variables (reported descriptively)
Measured: At study visit of 6, 12 18 or 24 months of age, depending on the enrollment age. The first visit in the study
Behavioral and emotional functioning assessed using the Strengths and Difficulties Questionnaire (SDQ)
Parent-reported behavioral and emotional functioning measured using the SDQ, a validated screening instrument. The SDQ assesses five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. Scores are reported per subscale and as a total difficulties score.
Unit of Measure: Scale score (0-40 total difficulties score)
Measured: study visit at 24 months of age
Development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
Standardized assessment of development administered by a trained examiner at age 24 months using the BSID-III (Cognitive and Motor Scale). Scores are reported as scaled scores with a normative mean of 10 (SD=3). Unit of Measure: Scaled score
Measured: study visit at 24 months of age
Plasma proteomic biomarker profile assessed via blood sample in children with SCD
A blood sample is collected from children with SCD to identify plasma proteomic biomarkers related to disease severity and neurological functioning. Samples are analyzed using unbiased proteomics analyses to characterize protein expression profiles.
Unit of Measure: Protein expression levels (reported as relative abundance)
Measured: study visit at 12 months of age and study visit at 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start16 Mar 2023
- Primary completion27 Nov 2025
- Study completion2 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Fijnvandraat, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721155
- Sponsor's protocol ID
- NL82004.018.22
- Other IDs
- 2022.0539
- Acronym
- ONSET
- Status last verified
- Jun 2026
- First submitted
- 22 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We intend to make IPD available to other researchers. However, we still need to develop the plan in collaboration with the privacy officer and legal research support.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Neurocognitive Assessment of Young Children With Sickle Cell Disease by Eye-Tracking
- ClinicalTrials.gov ID
- NCT07721155
- Acronym / sponsor ID
- ONSET / NL82004.018.22
- Conditions
- Sickle Cell Disease, Sickle Cell, Neurocognition, Child
- Keywords
- sickle cell, cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 27 Nov 2025 (actual)
- Study completion
- 2 Dec 2025 (actual)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: The main aim is to study early neurocognitive functioning and development in very young children with SCD. The secondary aims are to 1) (i) identify demographic, psychosocial and clinical determinants and (ii) identify biomarkers associated with early neurocognitive deficits in young children with SCD. 2) Analyze the association between early neurocognitive functioning and adaptive daily life functioning.
Study design: Prospective observational study with an accelerated longitudinal design. The accelerated longitudinal design allows for the inclusion of children from a broad age range (6 - 24 months). During the total study period of 30 months, children can enroll in the study at the ages of 6, 12, 18 and 24 months. After enrollment, children will visit every 6 months until they reach the age of 24 months. This design spans the age range of interest in a shorter period of time and a smaller load on participants as compared to a conventional longitudinal design.
Methods: Eye-tracking measurements will take place at every study visit. Demographic, psychosocial and clinical characteristics of the SCD group will be collected using prospective and structured clinical registration as part of regular clinical care. Demographic, psychosocial and clinical information of the control group will be collected using a parent questionnaire administered during the first and last study visit. Blood samples of children with SCD will be taken as part of regular blood checks at the age of 12 and/or 24 months (depending on the age of enrollment in the study). The Child Behavior Checklist, TNO AZL Preschool Children Quality of Life and the Bayley Scale of Infant and Child Development will be administered to all children at the age of 24 months.
Main study parameters/endpoints: Neurocognitive functioning, as measured using eye-tracking.
Secondary study parameters/ endpoints: The following determinants will be measured: Demographic, psychosocial and clinical characteristics, as measured as part of regular clinical care (SCD group) or via parent questionnaire (control group) and Biomarkers, as measured in blood (SCD group). Adaptive daily life functioning, as measured by quality of life, behavioural and emotional functioning questionnaire, and general (cognitive) development assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: eyetracking, Diagnostic Test: blood work, Other: Strengths and difficulties questionnaire (SDQ), Other: TNO AZL Preschool Children Quality of Life (TAPQOL), Other: Bayley Scale of Infant Development III (BSID)Infants between 6 and 24 months of age diagnosed with sickle cell disease |
| Healthy subject group | – | Other: eyetracking, Other: Strengths and difficulties questionnaire (SDQ), Other: TNO AZL Preschool Children Quality of Life (TAPQOL), Other: Bayley Scale of Infant Development III (BSID)Infants between 6 and 24 months of age without sickle cell disease |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children between the 6 and 24 months are invited to participate in the study.
Key inclusion criteria (3 listed)
- Age 6 - 24 months old
- Inhabitant of the Netherlands
- Written informed consent from parent/caretaker.
Key exclusion criteria (4 listed)
- Refused informed consent from parents/care-taker
- Diagnosis of visual impairment (which cannot be corrected by glasses)
- Diagnosis of a (co-morbid) congenital developmental condition
- Any neurological condition, unrelated to SCD, that could affect the central nervous system, such as brain trauma, epilepsy and meningitis/encephalitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eyetrackingEye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants. | Other | Healthy subject group, Patient group |
| blood workproteomics analyses methylation analyses | Diagnostic test | Patient group |
| 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 | Healthy subject group, Patient group |
| 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 | Healthy subject group, Patient group |
| Bayley Scale of Infant Development III (BSID)The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants | Other | Healthy subject group, Patient group |
Primary outcome
Processing speed in the gap condition (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The speed of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as reaction time (RT) via eye-tracking in infants with sickle cell disease (SCD). Unit of Measure: Milliseconds (ms)
Processing accuracy in the gap condition (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The precision of responding to a novel peripheral stimulus when the central stimulus disappears before the peripheral target appears. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD. Unit of Measure: Proportion of accurate trials
Orienting attention speed in the overlap condition (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The speed of orienting attention away from a central stimulus toward a peripheral target when the central stimulus remains on screen. Measured as RT in the overlap condition expressed as percentage change relative to mean RT in the gap condition, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Orienting attention accuracy in the overlap condition (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The precision of orienting attention toward a peripheral target when the central stimulus remains on screen. Measured as a binomial outcome (accurate/inaccurate) per trial via eye-tracking in infants with SCD. Unit of Measure: Proportion of accurate trials
Alerting attention without external cues (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to maintain focus on the task without external attention-grabbing cues. Measured as a binomial outcome per trial (completed without attention grabber: yes/no) via eye-tracking in infants with SCD. Unit of Measure: Proportion of trials completed without attention grabber
Sustained attention across trials (Gap/Overlap task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to attend to the task over a longer period. Measured as the number of trials completed expressed as a percentage of the total possible trials, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Fixation duration during free viewing (Freeview task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The amount of time the eyes remain stably focused on a specific location, defined as periods of stable gaze between successive saccades. Measured as mean fixation duration via eye-tracking in infants with SCD. Unit of Measure: Milliseconds (ms)
Habituation (Habituation task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The process of becoming accustomed to a repeatedly presented stimulus. Measured as the number of trials required to reach the pre-defined habituation criterion via eye-tracking in infants with SCD. Unit of Measure: Number of trials
Recognition (Habituation task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The ability to distinguish a previously presented stimulus from a novel one. Measured as the absolute difference in looking time toward the habituation stimulus versus the novel stimulus, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
Novelty preference (Habituation task)
Time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)
The tendency to inspect a novel stimulus relative to a previously presented one. Measured as looking time toward the novel stimulus as a percentage of total looking time, via eye-tracking in infants with SCD. Unit of Measure: Percentage (%)
4 secondary outcomes
Demographic and perinatal characteristics assessed via parent-reported questionnaire
Time frame: At study visit of 6, 12 18 or 24 months of age, depending on the enrollment age. The first visit in the study
Behavioral and emotional functioning assessed using the Strengths and Difficulties Questionnaire (SDQ)
Time frame: study visit at 24 months of age
Development assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
Time frame: study visit at 24 months of age
Plasma proteomic biomarker profile assessed via blood sample in children with SCD
Time frame: study visit at 12 months of age and study visit at 24 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided. We intend to make IPD available to other researchers. However, we still need to develop the plan in collaboration with the privacy officer and legal research support.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease and Sickle Cell, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Processing speed in the gap condition (Gap/Overlap task) (time frame: T1 (age 6 months), T2 (age 12 months), T3 (age 18 months), T4 (age 24 months)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.