Neurocognitive Deficit After Paediatric Transplantation: Understanding the Role of Environment and Physical Function

NCT07408713 | Not Yet Recruiting

• 1 other identifier: H-25062888, The NATURE Study
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HSCT; Pediatric Cancer; Pediatric Patients; Late Effect; Toxicity; Neurocognitive Dysfunction; Physical Function; Physical Capacity

Outcome Measures

Primary Outcomes (5)

• 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.

  T0: Within 30 days prior to HSCT T3: 1 year post HSCT

• 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.

  T0: Within 30 days prior to HSCT T3: 1 year post HSCT

• 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

  T0: Within 30 days prior to HSCT T3: 1 year post HSCT

• Performance on clinical neurocognitive tests - Visuomotor functions

  Visuomotor functions will be tested using Beery VMI (Beery-Buktenica Developmental Test of Visual-Motor Integration)

  T0: Within 30 days prior to HSCT T3: 1 year post HSCT

• Performance on clinical neurocognitive tests - Verbal learning

  Verbal learning will be tested using TOMAL-2 \>6 y of age

  T0: Within 30 days prior to HSCT T3: 1 year post HSCT

Secondary Outcomes (24)

• Isometric Muscle Strength

  T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT

• Handgrip strength

  T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT

• Muscle performance: Sit-to-stand 30 sec.

  T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT

• Muscle performance: Sit-to-stand 60 sec.

  T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT

• Muscle performance: Timed-up-and-go

  T0: Within 30 days prior to HSCT T1: During HSCT (at discharge, or day +42 at latest) T2: 6 months post HSCT T3: 1 year post HSCT

Study Arms (1)

Pediaric HSCT patients

Any pediatric HSCT patient in Denmark who meets the inclusion criteria from 2026 to 2031

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Recipient of allogeneic HSCT in the study period
• HSCT at the pediatric ward
• Age \<18 years at referral to HSCT
• Signed informed consent

You may not qualify if:

• \) Inability of legal guardian to speak and understand Danish

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Jascha Fonden: collaborator
• The Dagmar Marshall Foundation: collaborator
• Gangsted Foundation: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Neoplasms; Cognition Disorders

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Hilde H Uhlving, MD, PhD

CONTACT

+45 35451356; hilde.hylland.uhlving@regionh.dk

Kristian B Jeppesen

CONTACT

+45 24604838; kristian.bohn.jeppesen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 13, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: February 20, 2026

Record last verified: 2026-02

Locations

DK (1)