Motor-voice Assessment in Infants (MAMI)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 10
SponsorOhio State University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Behavioral observation

    Other intervention

    Behaviors will be observed in children's natural environment. With a digital health assessment.

Treatment groups

46 Participants
are divided into 1 treatment group
Group A: Full-term and pre-term infants1 intervention

Trial outcomes

Primary outcomes

1

General Movement Assessment

A non-invasive medical exam that evaluates an infant's spontaneous movements to identify neurological issues.

Time frame
At term-age, 3- and 9-months corrected age.
2

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.

Time frame
At term-age, 3- and 9-months corrected age.
3

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

Time frame
At term-age, 3- and 9-months corrected age.

Secondary outcomes

1

Ages and Stages Questionnaire

Screens children from birth to six years old for developmental and social-emotional progress.

Time frame
3- and 9-months corrected age.
2

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.

Time frame
Optional at 3.5- and 9-months corrected age.
3

Test of Infant Motor Performance

A 42-item assessment that measures an infant's motor skills and posture.

Time frame
Optional at 3.5- and 9-months corrected age.

Other outcomes

Sponsors and contacts

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