About this trial
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants.. The main questions it aims to answer are:
Identify voice factors among infants with newborn-detectable risk. Identify association between individual characteristics (Gestational age at birth, global function, motor-function) and voice factors.
Examine unique features of voice production that are present in infants with high-risk for Cerebral Palsy (CP).
Participants will be asked to upload a 3-minute videos of their child at term-age, 3.5-, and 9-months of age.
At the 3.5-month and 9-month time point parents can choose to attend an optional in-person assessment with their child.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
gestational age of 24 0/7 - 41 6/7,
admitted to the NICU,
medically stable by 40 weeks of gestation (including off ventilator support),
born to mothers 18 - 43 years old at the time of birth,
Disqualifiers
diagnosis of a genetic syndrome (e.g. Trisomy 21),
musculoskeletal deformity,
failed hearing screen.
Trial population
Full-term and pre-term infants
Trial design
Cohort
Prospective
Treatments tested in this trial
Behavioral observation
Other interventionBehaviors will be observed in children's natural environment. With a digital health assessment.
Treatment groups
Trial outcomes
Primary outcomes
General Movement Assessment
A non-invasive medical exam that evaluates an infant's spontaneous movements to identify neurological issues.
GMA-associated Motor Optimality Score
A numerical score derived from the General Movements Assessment (GMA), a method used to evaluate an infant's spontaneous movements, where a higher score indicates more optimal motor development and a lower score may suggest potential neurological concerns.
Voice acoustic analysis and number of vocalizations
Fundamental frequency, ratio of voiced sound, shimmer, jitter, Harmonic-to-noise ratio, frequencies of the first four formants
Secondary outcomes
Ages and Stages Questionnaire
Screens children from birth to six years old for developmental and social-emotional progress.
Bayley Scales of Infant Development
Comprehensive assessment tool for determining developmental delays in children. Scores are given as polytomous, ranging from 0 to 2. Scoring: 2 are Mastery, 1 is emerging, and 0 means absent. Mean score of 100 (Standard Deviation=15) at the 50th percentile signifies mid-average functioning. Scores below 85 (1 Standard Deviation below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay.
Test of Infant Motor Performance
A 42-item assessment that measures an infant's motor skills and posture.
Sponsors and contacts
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