Development of Motility and Cognition in Infants

NCT ID: NCT05527080

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2027-12-30

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.

Conditions

Neurodevelopmental Disorders; Developmental Delay; Development, Infant; Child Development; Cognitive Developmental Delay; Neurophysiologic Abnormality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

typically developing infants

recruitment at 5-8mos of age; infants are considered typically developing if they are born at term age with no neurologically significant medical history, and they are not medically followed up for a suspicion of such. The benchmark for this is taken from the nationally harmonized pre/postnatal screening practise.

No interventions assigned to this group

neurodevelopmental concern

recruitment at 5-8mos of age; infants are recruited from the outpatient clinic in the New Children's hospital (NCH). They have either a known perinatal risk factor (e.g.stroke, HIE, meningitis), or they are referred to pediatric neurologists at NCH due to a suspected delay or deviance in neurodevelopment.

physiotherapy

Intervention Type: OTHER

Some infants will receive physiotherapy as a part of their clinically indicated care.

hip dysplasia concern

recruitment at 2-6 weeks of age after perinatal clinical suspicion of hip dysplacia. These infants may be left out of follow-up (mild), or treated by orthopedic clinic with a soft brace (moderate) or a stronger cast (sever)

brace

Intervention Type: DEVICE

Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care

Interventions

physiotherapy

Some infants will receive physiotherapy as a part of their clinically indicated care.

Intervention Type: OTHER

brace

Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care

Intervention Type: DEVICE

Other Intervention Names

cast

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

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 26 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: collaborator

Aalto University

OTHER

Sponsor Role: collaborator

Tampere University

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sampsa Vanhatalo

professor in clinical neurophysiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sampsa K Vanhatalo, prof

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Locations

BABA, Clinical Trial Unit, New Children's Hospital

Helsinki, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Sampsa Vanhatalo, prof

Role: CONTACT

sampsa.vanhatalo@helsinki.fi

00358505286119

Leena Haataja, prof

Role: CONTACT

leena.haataja@hus.fi

00358504272069

Facility Contacts

Sampsa Vanhatalo, prof

Role: primary

Leena Haataja, prof

Role: backup

References

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.

Reference Type: BACKGROUND

PMID: 6957504 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35721830 (View on PubMed)

Related Links

https://www.babacenter.fi/hankkeet/pilke/

Official study website at the host lab pages

Other Identifiers

PILKE

Identifier Type: -

Identifier Source: org_study_id