Longitudinal Assessment of Early Premature Infant Skills for Audiovisual Speech Perception (Pré-AV)

November 17, 2025 updated by: University Hospital, Grenoble

From birth, babies perceive speech face to face with their interlocutors in audiovisual situations (AV): in addition to hearing them (auditory speech), they will also, in most cases, be able to observe their speaking faces (ex: mouth movements, lips, tongue etc.) . However, the ability to associate visual speech (ex: the movement of the lips of a speaking face) with auditory speech (ex: sound information) to which it corresponds is one of the earliest signs of language development. This ability to audiovisual association is present from the age of 2.5 months in infants with Typical Development and notably allows predicting the subsequent acquisition of vocabulary from the age of 12 months.

This skill allows infants to access redundant AV cues between auditory and visual speech. However this redundancy is a key piece of information allowing them, compared to an auditory situation alone, to focus their attention longer on the speech signal compared to the surrounding noises. This mechanism facilitates their subsequent language learning (identification of sounds, recognition and memorization of vocabulary, etc.) Alternatively, several studies show that children with atypical development of language and communication (e.g., Autistic Spectrum Disorder (ASD)), present clear difficulties in AV association, which may be, at least in part, at the origin of their subsequent linguistic and communicative difficulties.

On the other hand, children born prematurely have a higher risk of language disorders and ASD. Furthermore, some research shows that infants born prematurely exhibit an atypical exploration of speaking faces. This atypicity could explain the subsequent language difficulties observed in these populations.

Currently, we do not know at what age this ability develops in premature children and if it may be the cause of a language development disorder. The hypothesis would be that premature children develop this capacity later than full-term children. This could be one of the explanatory factors for language disorders in the first group. Our study would enrich this AV matching data in premature children and better understand the mechanisms of language delay in them. In addition to other studies, the absence of Matching AV at an expected age could be a strategy for screening for language disorders or ASD in children at risk. This would allow early implementation of intervention programs (speech therapy, parental education...)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Born before 34 SA at CHUGA and less than 4 months of actual age
  • French mother tongue (i.e., at least one of the two parents is a French mother tongue)
  • Legal representatives or parents who have signed a consent to participate in the study.

Exclusion Criteria:

  • Severe retinopathies
  • Severe neurological damage (grade 3 and 4 intraventricular hemorrhage and periventricular cavity leucomalacia)
  • Inconclusive hearing tests

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center

Visits will take place at 4 months of actual age and 4 months of corrected age (i.e., between 6.5-7 months of actual age for a newborn at 28 SA). These appointments will take place within the Neonatology department of the Couple Child Hospital.

The tests will be carried out by a researcher/student from Babylab, or a pediatric student.

The measurement of AV association abilities of infants is carried out through comparison of the gaze times of each infant with two speaking faces depending on the sound played in synchrony with the videos. The gaze time with a speaking face congruent with sound compared to the gaze time with a non-congruent speaking face is then coded image by image for each recording of the infant's gaze by 2 independent coders, naive to the hypotheses of the study.

And one parental questionnaire gathering lists of words usually known and produced by children at term in TTD aged 12 months. It has demonstrated its clinical effectiveness in detecting language delays.
Behavioral: Audiovisual association capability tests
Visits will take place at 4 months of actual age and 4 months of corrected age (i.e., between 6.5-7 months of actual age for a newborn at 28 SA). These appointments will take place within the Neonatology department of the Couple Child Hospital. The tests will be carried out by a researcher/student from Babylab, or a pediatric student. The measurement of AV association abilities of infants is carried out through comparison of the gaze times of each infant with two speaking faces depending on the sound played in synchrony with the videos. The gaze time with a speaking face congruent with sound compared to the gaze time with a non-congruent speaking face is then coded image by image for each recording of the infant's gaze by 2 independent coders, naive to the hypotheses of the study. And one parental questionnaire gathering lists of words usually known and produced by children at term in TTD aged 12 months. It has demonstrated its clinical effectiveness in detecting language delays.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion estimated by the ratio of the total gaze time to the speaking face articulating the same sound as that played auditively (congruent) on the total gaze time of the newborn at 4 months of actual age.
Time Frame: From enrollment to the end of treatment at 16 months of life
From enrollment to the end of treatment at 16 months of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Marie Dr Chevallier, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

November 17, 2025

First Submitted That Met QC Criteria

November 17, 2025

First Posted (Actual)

November 24, 2025

Study Record Updates

Last Update Posted (Actual)

November 24, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC24.0246
  • 2025-A00773-46 (Other Identifier: ID/RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

confidentiel data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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