Hematopoietic stem cell transplantation (HSCT) is a potentially life-saving treatment for children with relapsed or resistant leukemia and other life-threatening hematological and hereditary disorders. In Denmark, around 25 children undergo allogeneic HSCT every year, of these approximately 85-90% survive into adulthood.
The goal of this observational study is to learn about neurocognitive outcomes in children undergoing (HSCT) and to understand which clinical, physical, and environmental factors may affect neurocognitive development during the first year after transplant. The main questions it aims to answer are:
How does neurocognitive function change from before HSCT to one year after transplantation in pediatric patients?
Which clinical, physical, and environmental factors are linked to better or worse neurocognitive outcomes?
Participants will:
Complete neurocognitive tests before HSCT and at 1-year follow-up, covering intelligence, memory, attention, executive function, processing speed, and motor skills.
Undergo physical tests before HSCT, at hospital discharge, at 6-months follow-up, and at 1-year follow-up, including muscle strength, mobility, endurance, balance, and cardiopulmonary fitness (only at 1-year follow-up).
Wear activity trackers to measure physical activity and sedentary time during hospitalization at 6 months and 1-year post-HSCT.
Complete questionnaires about sleep, pain, quality of life, fatigue, family background, and exposure to outdoor and green spaces.
Have medical records reviewed for treatment-related side effects, immune recovery, inflammation, and pain management.
This study will help understand how neurocognitive function develops after HSCT in children and which factors (clinical, physical, or environmental) may support better recovery and well-being.
Recipient of allogeneic HSCT in the study period
HSCT at the pediatric ward
Age <18 years at referral to HSCT
Signed informed consent
None
Patients: In Denmark 20-25 children below the age of 18 years undergo HSCT every year, which means that 100-125 patients will be eligible for inclusion in the study period. To increase the total number of participants available only for 1-year outcome analyses, we will additionally include \~25 patients, in a "catch-up cohort". These participants will undergo the same 1 year follow-up assessments, Parents At least one parent per included patient will be included as a study participant. Inclusion criteria for parents 1. Parent or legal guardian of an included patient 2. Present during the child's hospitalization (the parent most often staying with the child) 3. Able to speak and understand Danish 4. Signed informed consent Exclusion criteria for parents 1\) Inability to understand or complete the questionnaire in Danish
Cohort
Prospective
Not listed
Performance on clinical neurocognitive tests
Scores on the clinical neurocognitive tests (Bayley-III: Bayley Scales of Infant and Toddler Development - Third Edition, WPPSY-IV: Wechsler Preschool and Primary Scale of Intelligence 2.6-7.7 years of age, WISC-V: Wechler Intelligence Scale for Children Fifth edition for participants 7-15.9 years of age, WAIS-IV: Wechler Adult Intelligence Scale Fourth edition for participants 16 years of age or older). Tested domains: Non-verbal reasoning, verbal reasoning, Working memory, Processing Speed Scaled scores range from 0-19, higher = better performance.
Performance on clinical neurocognitive tests - Excecutive functioning
Excecutive functioning will be tested using D-KEFS (Delis-Kaplan Executive Function System) for all participants \>8 y of age.
Performance on clinical neurocognitive tests - Sustained attention
Sustained attention will be tested using CPT-3 (Conners Continuous Performance Test, 3rd Edition) for for all participants \>8 y of age
Performance on clinical neurocognitive tests - Visuomotor functions
Visuomotor functions will be tested using Beery VMI (Beery-Buktenica Developmental Test of Visual-Motor Integration)
Isometric Muscle Strength
Isometric knee strength will be measured with a handheld dynamometer (CITEC handheld dynamometer, type 3002, CIT Technics, Haren, Netherlands). Maximum isometric contraction will be evaluated using the "break technique" (Beenakker et al, 2001). The highest value out of three repetitions will be counted as the maximum strength and kept for analysis. The handheld dynamometry method has shown high validity (r = 0.74 and r = 0.98) and moderate intertester reliability (r = 0.42 to r = 0.73) in healthy and chronically ill children and adolescents (Brussock CM et al. (1992)), (Stuberg WA et al (1988)) and is considered a reliable and valid instrument for muscle strength assessment in a clinical setting compared to the gold standard isokinetic dynamometry (Stark T et al (2011)).
Handgrip strength
Handgrip strength will be measured using a hand-held dynamometer. Participants are placed in a seated position with the elbow flexed at 90°, with three attempts performed for each hand. During testing, the participant will be encouraged to exhibit the best possible force, and the best measure in the strongest hand will be used as the test score. Handgrip strength is also used as a surrogate measure for upper-body physical function (Bohannon RW et al (2001)), Adam C et al (1988))
Muscle performance: Sit-to-stand 30 sec.
Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
Muscle performance: Sit-to-stand 60 sec.
Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
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Rigshospitalet, Denmark
Lead sponsor
Jascha Fonden
Collaborator
The Dagmar Marshall Foundation
Collaborator
Gangsted Foundation
Collaborator
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