Clinical trial NCT04321200: PANDA Gym: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
Official title: Automated Assessment of Neurodevelopment in Infants at Risk for Motor Disability
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pediatric ALL
Infant Development
Neurodevelopmental Disorders
Keywords: Infants
Neurodevelopment
Developmental Delays
Electronics
Early Intervention
Sensory and Motor
NICU
Natural Play
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2020-03-25
Enrollment: 1700
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study 1: 150 infants (75 with early brain injury, 75 Control). Age 1-6 months. Study 2: 50 infants (25 with early brain injury, 25 Control). Age 1 month. Study 3: 1200 infants (400 with EBI, 400 preterm without EBI/risk for future disability, 400 controls) from video data. Age 1-6 months.

Infants without EBI/risk for future disability: Infants without known brain injuries, but with a history of preterm birth less than 32 week gestation, significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.

Brief summary: Early childhood detection of motor delays or impairments provides the opportunity for early treatment which improves health outcomes. This study will use state of the art sensors combined with machine learning algorithms to develop objective, accurate, easy-to-use tools for the early scoring of deficits and lays the foundation for the early prediction of physical disability.

Detailed description: For children with neurodevelopmental disabilities, early treatment in the first year of life improves long-term outcomes. However, the investigators are currently held back by inadequacies of available clinical tests to measure and predict impairment. Existing tests are hard to administer, require specialized training, and have limited long-term predictive value. There is a critical need to develop an objective, accurate, easy-to-use tool for the early prediction of long-term physical disability. The field of pediatrics and infant development would greatly benefit from a quantitative score that would correlate with existing clinical measures used today to detect movement impairments in very young infants. To realize a new generation of tests that will be easy to administer, the investigators will obtain large datasets of infants playing in an instrumented gym or simply being recorded while moving in a supine posture. Video and sensor data analyses will convert movement into feature vectors based on our knowledge of the problem domain. Our approach will use machine learning to relate these feature vectors to currently recommended clinical tests or other ground truth information. The power of this design is that algorithms can utilize many aspects of movement to produce the relevant scores.

Eligibility criteria: Infants, male and female, between 0-6 months (Infants older than 6 months before initial enrollment will be excluded).

* Infants with early brain injury (EBI):

  * Hydrocephalus
  * Hypoxic-ischemic encephalopathy (HIE)
  * Periventricular leukomalacia (PVL)
  * Intraventricular hemorrhage (IVH)
  * Stroke
* Healthy infants (controls):

  o No history of early brain injury (EBI)
* Infants without EBI/risk for future disability:

  * Infants without known brain injuries, but with a history of preterm birth less than 32-week gestation with significant medical problems, difficulty eating, or who lack head control at 4 months of age or later will be classified as moderate risk.

Primary outcomes:
measure: Prechtl's General Movements Assessment (GMA) score
timeFrame: 1 months
measure: Prechtl's General Movements Assessment (GMA) score
timeFrame: 2 months
measure: Prechtl's General Movements Assessment (GMA) score
timeFrame: 3 months
measure: Prechtl's General Movements Assessment (GMA) score
timeFrame: 4 months
measure: Prechtl's General Movements Assessment (GMA) score
timeFrame: 5 months
measure: The Test of Infant Motor Performance (TIMP) score
timeFrame: 1 month
measure: The Test of Infant Motor Performance (TIMP) score
timeFrame: 2 months
measure: The Test of Infant Motor Performance (TIMP) score
timeFrame: 3 months
measure: The Test of Infant Motor Performance (TIMP) score
timeFrame: 4 months
measure: Alberta Infant Motor Scale (AIMS) score
timeFrame: 3 months
measure: Alberta Infant Motor Scale (AIMS) score
timeFrame: 4 months
measure: Alberta Infant Motor Scale (AIMS) score
timeFrame: 5 months
measure: Alberta Infant Motor Scale (AIMS) score
timeFrame: 6 months
measure: Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 1 months
measure: Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 2 months
measure: Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 3 months
measure: Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 4 months
measure: Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 5 months
measure: Ability to predict The Hammersmith Infant Neurological Examination (HINE) score
timeFrame: 6 months
measure: Ability to predict The Test of Infant Motor Performance (TIMP) score
timeFrame: 6 months
measure: Ability to predict the Alberta Infant Motor Scale (AIMS) score
timeFrame: 6 months
Secondary outcomes:
measure: Average Path Length
timeFrame: 1 month
measure: Average Path Length
timeFrame: 6 months
measure: Toy contact time
timeFrame: 1 month
measure: Toy contact time
timeFrame: 6 months
measure: Toy contact frequency
timeFrame: 1 month
measure: Toy contact frequency
timeFrame: 6 month
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Childrens Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: The University of Pennsylvania
name: Michelle J Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S. A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol. 2013 Oct;55(10):885-910. doi: 10.1111/dmcn.12246. Epub 2013 Aug 21.
citation: Noble Y, Boyd R. Neonatal assessments for the preterm infant up to 4 months corrected age: a systematic review. Dev Med Child Neurol. 2012 Feb;54(2):129-39. doi: 10.1111/j.1469-8749.2010.03903.x. Epub 2011 Dec 5.
citation: Einspieler C, Bos AF, Libertus ME, Marschik PB. The General Movement Assessment Helps Us to Identify Preterm Infants at Risk for Cognitive Dysfunction. Front Psychol. 2016 Mar 22;7:406. doi: 10.3389/fpsyg.2016.00406. eCollection 2016.
citation: Rydz D, Shevell MI, Majnemer A, Oskoui M. Developmental screening. J Child Neurol. 2005 Jan;20(1):4-21. doi: 10.1177/08830738050200010201.