| Registry | NCT05527080, acronym PILKE |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 250 (Estimated) |
| Sponsor | Helsinki University Central Hospital (Other); collaborators: University of Helsinki, Aalto University, Tampere University |
| Conditions | Neurodevelopmental Disorders, Developmental Delay, Development, Infant, Child Development, Cognitive Developmental Delay, Neurophysiologic Abnormality |
| Interventions | physiotherapy, brace (Other, device) |
| Dates | start 2021-10-01, primary completion 2026-12-30 (estimated), completion 2027-12-30 (estimated), first posted 2022-09-02, last updated 2025-04-03 |
| Locations | 1 site in Finland |
Related Papers Related Patents Related Grants Related Experts
All trials for Neurodevelopmental Disorders All trials for Developmental Delay All trials of physiotherapy All trials of brace
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. | ||
| neurodevelopmental concern | Other: physiotherapy | 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. | |
| hip dysplasia concern | Device: brace | 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) |
Sex: All, ages: 5 Months to 26 Months, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| BABA, Clinical Trial Unit, New Children's Hospital | Helsinki | Finland | Recruiting |