BABA, Clinical Trial Unit, New Children's Hospital
Helsinki, Finland
Location status: Recruiting
Location contact
Leena Haataja, prof
CONTACT
Sampsa Vanhatalo, prof
CONTACT
NCT Number: NCT05527080
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.
Interested in participating?
Request Info5 month–26 month
All sexes
Observational
Helsinki, Finland
Location status: Recruiting
Leena Haataja, prof
CONTACT
Sampsa Vanhatalo, prof
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Some infants will receive physiotherapy as a part of their clinically indicated care.
Some infants in the hip dysplasia group will receive brace and/or cast as a part of their clinically indicated care
Other names: cast
Time frame: 24 months
The total score of the neuropsychological examination Bayley scales III will be used
Time frame: 12 months
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)
Contact information is provided by the study sponsor or research team.
Leena Haataja, prof
CONTACT
Sampsa Vanhatalo, prof
CONTACT
Helsinki University Central Hospital
Other
Acronym: PILKE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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