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Not yet recruitingNCT06645717Updated Oct 17, 2024

Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period

An observational study in Motor Disorders, Neurodevelopmental Disorders and Premature Birth, sponsored by Karolinska Institutet. Not yet recruiting. Open to participants aged 2 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-10-17.

Sponsored by Karolinska Institutet · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
2,900
Ages
2 Years to 14 Years
Sex
All
01

Study summary

The overall aim of the study is to evaluate the prevalence of motor- and neurological disorders (cerebral pares and other less severe motor disorders) in Swedish infants with a high-risk neonatal period and to elucidate whether these children receive motor related health care (MRHC) at 2 and or 5,5 years of age.

Read the detailed description

Specific aims:

  1. To evaluate the prevalence of cerebral pares (CP) and other motor impairments in Swedish infants with a high-risk neonatal period (total group and sub-groups), followed up at age 2 and or 5,5 years.
  2. To study how retinopathy of prematurity (ROP) affects the risk for later gross and fine motor impairments in children with a high-risk neonatal period, with specific reference to children born extremely preterm.
  3. To study the number of children, with a high-risk neonatal period having access to MRHC (defined as having at least one visit over the previous year to a physiotherapist and/or an occupational therapist).

    • To evaluate possible associations between receiving MRHC and maternal-, pregnancy- and neonatal factors.
    • To study the association between receiving MRHC and cognition, motor function, behavior, quality of life and autism spectrum disorders (ASD) at age 2 and 5,5 years.
  4. To study if there are regional differences in Sweden in follow-up of CP and less severe motor disorders at the age of 2 and 5,5 years.
  5. To assess the completeness and agreement of some developmental and motor disorders, neurosensory impairments and chronical diseases in the Swedish Neonatal Quality Register (SNQ) with the Swedish National Patient Register (NPR) and The Cerebral Palsy Follow-Up Program (CPUP).
02

Conditions studied

  • Motor Disorders
  • Neurodevelopmental Disorders
  • Premature Birth
  • Hypoxic-Ischemic Encephalopathy
  • Small for Gestational Age At Delivery

Keywords

  • brain
  • HIE
  • SGA
  • preterm
  • neurodevelopment
  • motor related healthcare
  • children
  • motor function
03

In context

Motor Disorders

73 studies on the registry are indexed under Motor Disorders; 24 are open to participants now.

This study's planned enrollment of 2,900 is above the median of 60 across 21 observational studies indexed under Motor Disorders.

Browse Motor Disorders studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Today, data from 2,900 children are available in the follow-up protocol for 5,5 years of age in the SNQ according to the vice registry manager for the SNQ registry (Stellan Håkansson 08-03-2023).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Included in the SNQ registry and having a follow-up protocol for 2 and/or 5 years of age.

Exclusion criteria

Exclusion Criteria:

  • None if the above inclusion criteria ar true.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
2,900 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Movement assessment battery for children Second Edition (MABC-2)

    The MABC-2 is designed to identify and describe motor disorders in children and adolescents, from three to sixteen years of age. It gives information about both gross and fine motor functioning. It consists of eight tasks/items that are aggregated into three components: (1) Manual dexterity, that tests fine motor skills through three tasks, (2) Aiming and catching evaluates aiming and catching skills through two tasks/items, (3) Balance assesses gross motor skills through three tasks. The scoring procedure includes transforming raw scores into age adjusted scaled scores (mean 10; SD 3) for each item. The scaled scores of items within the same component are summed to obtain a total component score which is then converted into a scaled score and a percentil rank. The scaled scores of alla items are then summed to provide a total motor score that is converted into a total scaled score and percentile. Higher scores indicate better performance.

    Time frame: Until 2026-10-01

  2. Bayley Scales of Infant Development Third Edition (Bayley III)

    The Bayley-III is an assessment tool to identify developmental impairments from birth to the age of 3. It includes cognitive, language, motor (gross and fine), social-emotional and adaptive behavior scales. It is often used in research and clinical work. Raw scores of successfully completed items are converted to scale scores and to composite scores. These scores are used to determine the child's performance compared with norms taken from typically developing children of their age (in months).

    Time frame: Until 2026-10-01

  3. Wechsler Preschool and Primary Scale of Intelligence Fourth Edition (WPPSI-IV)

    The WPPSI-IV is a measure of general cognitive development for preschoolers and young children. The test is divided in two age intervals, 2 years and 6 months to 3 years and 11 months, and from 4 years to 7 years and 7 months. The younger age interval is divided into three primary index scales, verbal comprehension index (VCI), visual spatial index (VSI), and working memory index (WMI) and the older age interval consists of five primary index scales VCI, VSI, WMI, fluid reasoning index (FRI), and processing speed index (PSI). These primary index scales put together give a full-scale intelligence quotient (FSIQ) score.

    Time frame: Until 2026-10-01

  4. The developmental coordination disorder questionnaire 2007 (DCDQ'07)

    DCDQ-07 is a brief parent questionnaire designed to screen for coordination disorders in children between 5 and 15. The DCDQ-07 is considered a valid clinical screening tool for children who have coordination disorders. DCDQ-07 has been validated against MABC-2. The questionnaire consists of 15 questions with answers from 1-5. All the answers are summed up together to a total score in the end. The higher the total score the less likely the child has developmental coordination disorder.

    Time frame: Until 2026-10-01

  5. Movement Assessment battery for children Secondary Edition (MABC-2 checklist)

    Parent and teacher reported MABC-2 checklist is a screening tool for motor impairments in children between 3 and 16 years of age. It meets standards for reliability and validity when used in research and every day clinical work. The checklist contains two 15-item sections. Section A evaluates movement in both a static and/or predictable environment. Section B evaluates movement in a dynamic and/or unpredictable environment. The items in both sections are rated on a four-point liket rating scale ranging from very well to not close. The MABC-2 checklist total motor score is the sum of the scores for the two sections; the higher the score; the poorer the performance.

    Time frame: Until 2026-10-01

  6. Kidsscreen 10

    Kidsscreen 10 is used to assess self-reported subjective health and the mental, psychological and social well-being of children between 7 to 17 years of age. The instrument has shown adequate psychometrics. Kidsscreen 10 provides a global health related quality of life (HRQoL) and is recommended for use in larger studies. The kid screen-10 score contains 10 items. Each item is answered on a 5-point response scale. The responses are coded so that higher indicate better HRQoL.

    Time frame: Until 2026-10-01

  7. Pediatric Quality of Life Inventory - Family Impact Module (PedsQL)

    Pedsql - Family Impact Module was designed to measure the impact of pediatric chronic health on the family and parents. This module encompasses six scales measuring parent self-reported functioning including physical, emotional, social and cognitive functioning, communication and worry. The module aslo measures parent-reported daily activities and family relationships. A 5-point response scale is used so that higher scores indicate better functioning.

    Time frame: Until 2026-10-01

  8. MRHC motor related healthcare

    Receiving MRHC will be defined as having at least one visit to a physiotherapist and/or an occupational therapist during the previous year.

    Time frame: Until 2026-10-01

  9. Study specific questionaire

    Study specific questionnaire about motor related health care and motor function. It consists of 6 main questions. The questionnaire does not give a total score but gives specific information about motor functioning, physical activity and visits to physiotherapists/pediatric neurologist/occupational therapist.

    Time frame: Until 2026-10-01

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jan 2025; primary completion for Oct 2026, 21 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2024
First posted
Oct 17, 2024
StartEst.
Jan 1, 2025
Primary completionEst.
Oct 1, 2026
CompletionEst.
Oct 1, 2034
Last update
Oct 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06645717
Responsible party
Maria Örtqvist (Associate professor, physiotherapist, Karolinska Institutet) — Principal investigator
First posted
Oct 17, 2024
Start date
Jan 1, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2034 (estimated)
Last update
Oct 17, 2024

Study contacts

Daniela Nosko, MD
Contact
daniela.nosko@ki.se
+46768494609
Maria Örtqvist, PhD
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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