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

NCT06645717 | Not Yet Recruiting

• 1 other identifier: 2024-01633-01
• Study Type: observational
• Target: 2,900
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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.

  Until 2026-10-01

• 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).

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

• 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.

  Until 2026-10-01

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

MeSH Terms

Conditions

Motor Disorders; Neurodevelopmental Disorders; Premature Birth; Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Örtqvist, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Nosko, MD

CONTACT

+46768494609; daniela.nosko@ki.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, physiotherapist

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 17, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2034
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share