Clinical trial NCT06645717: Neuromotor Development and Motor Related Health Care in Children with a High Risk Neonatal Period
Official title: Neuromotor Development in Children Enrolled in the Swedish Neonatal Follow-up Program and Access to Motor Related Healthcare
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 2900
Sex: ALL
Minimum age (years): 2
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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).

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.

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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None if the above inclusion criteria ar true.

Primary outcomes:
measure: Movement assessment battery for children Second Edition (MABC-2)
timeFrame: Until 2026-10-01
measure: Bayley Scales of Infant Development Third Edition (Bayley III)
timeFrame: Until 2026-10-01
measure: Wechsler Preschool and Primary Scale of Intelligence Fourth Edition (WPPSI-IV)
timeFrame: Until 2026-10-01
measure: The developmental coordination disorder questionnaire 2007 (DCDQ'07)
timeFrame: Until 2026-10-01
measure: Movement Assessment battery for children Secondary Edition (MABC-2 checklist)
timeFrame: Until 2026-10-01
measure: Kidsscreen 10
timeFrame: Until 2026-10-01
measure: Pediatric Quality of Life Inventory - Family Impact Module (PedsQL)
timeFrame: Until 2026-10-01
measure: MRHC motor related healthcare
timeFrame: Until 2026-10-01
measure: Study specific questionaire
timeFrame: Until 2026-10-01
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Maria Örtqvist, PhD
role: PRINCIPAL_INVESTIGATOR
References: