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Clinical Trials in France / NCT07245693
Starting soon Not applicable

Longitudinal Assessment of Early Premature Infant Skills for Audiovisual Speech Perception

NCT07245693 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-01-01
Last updated
2025-11-24

Condition(s) studied

Premature BabyNeurocognition, Child

Investigational drug(s) / intervention(s)

Audiovisual association capability tests

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.

Study summary

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...)

Eligibility

Sex
ALL
Min age
4 Months
Max age
35 Weeks
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital Grenoble Grenoble France

More University Hospital, Grenoble trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07245693 on ClinicalTrials.gov ↗ ← All trials in France