Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT06807203

Conditions

Cerebral Palsy Infantile

Pre-Term

Motor Delay

Neurodevelopmental Disorders

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Behavioral observation

Study Details

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

Study ID

NCT06807203

Start date

Oct 22, 2025

Status verified date

Mar, 2026

Completion date

Jan 28, 2030

Anticipated

Primary completion date

Jan 28, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Design

Enrollment

46 participants

Anticipated

Interventions and Outcome Measures

Arms

Full-term and pre-term infants

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

Interventions

Behavioral observation

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

Primary outcome measure

  • General Movement Assessment [ Time Frame: At term-age, 3- and 9-months corrected age. ]
  • GMA-associated Motor Optimality Score [ Time Frame: At term-age, 3- and 9-months corrected age. ]
  • Voice acoustic analysis and number of vocalizations [ Time Frame: At term-age, 3- and 9-months corrected age. ]

Central Contacts and Locations

Locations

The Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Petra Sternberg, PhD

614-572-5446petra.sternberg@osumc.edu

More Information

Sponsor

Ohio State University

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-03-27.