Development of Motility and Cognition in Infants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-26
SponsorHelsinki University Central Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

age at enrollment 5-8mos

typically developing

Disqualifiers

all neurologically significant medical histories during pregnancy, at birth or postnatally

suspicion of developmental delay

suspicion or diagnosis of syndromes with neuromotor symptoms

Trial 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)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • physiotherapy

    Other intervention

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

  • brace

    Device

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

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: typically developing infants0 interventions
Group B: neurodevelopmental concern1 intervention
Group C: hip dysplasia concern1 intervention

Trial outcomes

Primary outcomes

1

neurocognitive development

The total score of the neuropsychological examination Bayley scales III will be used

Time frame
24 months
2

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)

Time frame
12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Helsinki University Central Hospital

Lead sponsor

University of Helsinki

Collaborator

Aalto University

Collaborator

Tampere University

Collaborator