Clinical trial NCT05527080: Development of Motility and Cognition in Infants
Official title: Development of Motility and Cognition in Infants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurodevelopmental Disorders
Developmental Delay
Development, Infant
Child Development
Cognitive Developmental Delay
Neurophysiologic Abnormality
Keywords: wearable
medical wearable
human activity recognition
growth chart
neurodevelopment
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Aalto University
name: Tampere University
First posted: 2022-09-02
Enrollment: 250
Sex: ALL
Minimum age (years): 5
Maximum age (years): 26
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants at 5-8mos of age. Upper age limit may be extended until the infant learns to stand up.

Groups have either no medical history (#1) or a suspicion or risk of neurodevelopmental delay/deviance (#2)

Brief summary: PILKE study uses wearables for assessing motor development in infants in order to define functional growth trajectories in the normal infants and infants at risk of neurological compromise. In addition, PILKE studies correlation of early motor development to later neurocognitive development.

Detailed description: PILKE study builds on the recent development of an infant wearable, MAIJU, a multisensor garment that can be used to quantify infants posture and movement patterns out-of-hospital. The study will recruit typically developing infants (control group) and infants with an identified or suspected risk of neurodevelopmental compromise, as well as infants undergoing orthopedic follow-up for hip issues.

Infants will be examined and treated according to clinical routine practise, while MAIJU and other novel measures are added to monitor aspects of neurodevelopment. Recordings with MAIJU will be done every 6-8 weeks from about 5 months to 18 months of age, and the neuropsychological outcome is assessed using Bayley scales at two years of age.

The study is observational by design, and the trajectories of motor performance are compared to other clinically identified measures of development.

Eligibility criteria: Inclusion Criteria:

* age at enrollment 5-8mos
* typically developing

Exclusion Criteria:

* all neurologically significant medical histories during pregnancy, at birth or postnatally
* suspicion of developmental delay
* suspicion or diagnosis of syndromes with neuromotor symptoms

Primary outcomes:
measure: neurocognitive development
timeFrame: 24 months
measure: neurological development
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: BABA, Clinical Trial Unit, New Children's Hospital
Study officials:
affiliation: University of Helsinki
name: Sampsa K Vanhatalo, prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yamada T, Nakamura K, Horie K, Yamashita Y, Iwaku M. [Extent of odontoblast process in normal and carious dentin]. Kokubyo Gakkai Zasshi. 1982 Jun;49(2):325-32. No abstract available. Japanese.
citation: Airaksinen M, Gallen A, Kivi A, Vijayakrishnan P, Hayrinen T, Ilen E, Rasanen O, Haataja LM, Vanhatalo S. Intelligent wearable allows out-of-the-lab tracking of developing motor abilities in infants. Commun Med (Lond). 2022 Jun 15;2:69. doi: 10.1038/s43856-022-00131-6. eCollection 2022.