AzTrials
AzTrials

Cerebral Palsy InfantileMAMINCT06807203

Motor-voice Assessment in Infants (MAMI)

An observational study of Cerebral Palsy Infantile and Pre-Term, run by Ohio State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 10 days
Conditions the study is for
Cerebral Palsy Infantile, Pre-Term, Motor Delay
What is being tested?
Behavioral observation
How many people
46 participants
Where
1 siteUnited States
Study dates
22 Oct 2025to 28 Jan 2030
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 10 days
  • All sexes
  • Child

Study population: Full-term and pre-term infants

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • The Ohio State University

    Columbus, Ohio, 43210

    Petra Sternberg, PhD, 614-572-5446, petra.sternberg@osumc.edu

    Recruiting

Other trials in United States

About this study

Official title: Spontaneous Motor-voice Assessment in Infants Using Video and Audio Recordings.

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.

Read more

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.

Read the detailed description

In the first months of life, infants continually produce and modify motor behaviors and acquire new ones. They kick their legs in patterns that show temporal and spatial organization, they flap their arms in a march to midline, and gain strength against gravity with their head and trunk. Most of this happens spontaneously without specific toys or environmental modifications. Over the same time period, infant also continually use and modify their voice and acquire new vocal behaviors. Three broad categories of sound occurring in vocal communication are described in infants: cries, laughs, and protophones which are seen as the precursors to speech. Motor function and voice production are not isolated developmental processes --they are present and developing in the same baby, and, they have common ontological origins in the motor cortex. It can be argued that the earliest precursors to language, spontaneous cries and protophones, are the result of a "movement" originating in signals from the CNS that can be studied to detect health and disease in combination with physical movements. Grounded in the developmental cascades framework and developmental neuroscience this project is informed by clinical and scientific advancements in: 1) Methodology for reliably scoring of spontaneous behaviors in the first months of life that are sensitive to normal and disordered movements and predictive of neurodevelopmental disabilities including Cerebral Palsy (CP) - particularly the General Movements Assessment (GMA) and associated Motor Optimality score (MOS); 2) The ability to detect abnormal voice production in populations with neurodevelopmental disabilities using acoustic analysis. Motor function and speech production are complex processes that require precise coordination of 100s of muscles. In disease states, with damage to the CNS, poor coordination can be observed through motor and voice behaviors and specific diseases identified. Importantly, motor and voice are some of the first indicators of health after birth that occur spontaneously (e.g. crying, kicking, muscle tone). Even more importantly, motor function and voice production can be measured, non-invasively, in early infancy including the newborn period.

The overall goal is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants. Disabilities are difficult to identify in this ultra-early infancy period because infants cannot speak or produce voluntary movements necessary for formal testing. Furthermore, medical testing such as MRI is expensive, not accessible everywhere, and has limited predictive value for neurodevelopmental outcomes. Laboratories have demonstrated the promise of using video and audio recordings from spontaneous and elicited behaviors to identify disordered motor or voice production from normal. Arm and leg movements, midline behaviors, writhing and fidgety movements are all implicated in neurodevelopmental outcomes and some are uniquely implicated in the identification of cerebral palsy (CP). Vocalizations (grunts, squeals, raspberries, trills, clicks), crying, protophones -- core behavioral features of voice production, are also implicated in neurodevelopmental outcomes; and some are uniquely implicated in autism, but none have been consistently evaluated in infants. Multidimensional assessment of motor function and voice production will be used at two time periods that are relevant to the earliest possible screening and detection of neurodevelopmental disorders and important for general movement assessment: term-equivalent age (writhing period), 3.5 months of corrected age (fidgety period), and 9 month of corrected age in N=46 infants with newborn-detectable risk. To fully capture the complexity of motor function and voice production in infancy, a battery of tests with emerging sensitivity will be used to measure disability during development and the sensitivity to detect both major impairments and small delays; some of these measures can be reliably tested simultaneously. Tests include: (1) General Movement Analysis (GMA); (2) the GMA-associated Motor Optimality Score (MOS); (3) Voice acoustic analysis (fundamental frequency, ratio of voiced sound, shimmer, jitter, Harmonic-to-noise ratio, frequencies of the first four formants), and number of vocalizations; (4) Bayley Scales of Infant Development (Bayley-4) for motor, cognitive, and language function; (5) Test of Infant Motor Performance (TIMP); and (6) Ages and Stages Questionnaire (ASQ).

Being tested
Behavioral observation
Keywords
Digital health,, Motor assessment,, voice assessment,, cognition, neurodevelopment,
Medical subject headings
Cerebral Palsy, Premature Birth, Psychomotor Disorders, Neurodevelopmental Disorders, Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral observationOther

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

Study groups in NCT06807203
Study groupRoleWhat they receive
Full-term and pre-term infantsObservational study for motor, cognitive, language, voice impairments.
Receives: Other: Behavioral observation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. General Movement Assessment

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

    Measured: 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.

    Measured: 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

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

Secondary outcomes (3)
  1. Ages and Stages Questionnaire

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

    Measured: 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.

    Measured: 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.

    Measured: Optional at 3.5- and 9-months corrected age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start22 Oct 2025
  3. Primary completion28 Jan 2028 (estimated)
  4. Study completion28 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807203
Sponsor's protocol ID
2024B0149
Acronym
MAMI
Status last verified
Mar 2026
First submitted
29 Jan 2025
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebral Palsy Infantile and Pre-Term, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

General Movement Assessment (time frame: At term-age, 3- and 9-months corrected age.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in