Development of Motility and Cognition in Infants

Child Development Clinical Trial

— PILKE  

Official title:

Development of Motility and Cognition in Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05527080
• Other study ID #: PILKE
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Helsinki University Central Hospital
• Contact: Sampsa Vanhatalo, prof
• Phone: 00358505286119
• Email: sampsa.vanhatalo[@]helsinki.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Months to 26 Months

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
Finland	BABA, Clinical Trial Unit, New Children's Hospital	Helsinki

Sponsors (4)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University, Tampere University, University of Helsinki

Country where clinical trial is conducted

Finland, 

References & Publications (2)

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. — View Citation

Airaksinen M, Rasanen O, Ilen E, Hayrinen T, Kivi A, Marchi V, Gallen A, Blom S, Varhe A, Kaartinen N, Haataja L, Vanhatalo S. Automatic Posture and Movement Tracking of Infants with Wearable Movement Sensors. Sci Rep. 2020 Jan 13;10(1):169. doi: 10.1038/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neurocognitive development	The total score of the neuropsychological examination Bayley scales III will be used	24 months
Primary	neurological development	Binary information (normal vs abnormal) is taken from the postnatal follow-up clinic inspection that is done according to the national standards (www.thl.fi)	12 months

External Links

•   Official study website at the host lab pages