Motor-voice Assessment in Infants (MAMI)

NCT06807203 | Recruiting

• 1 other identifier: 2024B0149
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebral Palsy Infantile; Pre-Term; Motor Delay; Neurodevelopmental Disorders; Autism Spectrum Disorder

Keywords

Digital health,; Motor assessment,; voice assessment,; cognition; neurodevelopment,

Outcome Measures

Primary Outcomes (3)

• General Movement Assessment

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

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

• 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.

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

• 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

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

Secondary Outcomes (3)

• Ages and Stages Questionnaire

  3- and 9-months corrected age.

• Bayley Scales of Infant Development

  Optional at 3.5- and 9-months corrected age.

• Test of Infant Motor Performance

  Optional at 3.5- and 9-months corrected age.

Study Arms (1)

Full-term and pre-term infants

Observational study for motor, cognitive, language, voice impairments.

Other: Behavioral observation

Interventions

Behavioral observation OTHER

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

Full-term and pre-term infants

Eligibility Criteria

• Age: Up to 10 Days
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Full-term and pre-term infants

You may qualify if:

• 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,
• one parent fluent in English.

You may not qualify if:

• diagnosis of a genetic syndrome (e.g. Trisomy 21),
• musculoskeletal deformity,
• failed hearing screen.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy; Premature Birth; Psychomotor Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder

Interventions

Behavior Observation Techniques

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Child Development Disorders, Pervasive

Intervention Hierarchy (Ancestors)

Psychological Techniques; Investigative Techniques; Behavioral Disciplines and Activities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): January 28, 2028
• Study Completion (Estimated): January 28, 2030
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)