| Registry | NCT07245693, acronym Pré-AV |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, health services research |
| Enrollment | 60 (Estimated) |
| Sponsor | University Hospital, Grenoble (Other) |
| Conditions | Premature Baby, Neurocognition, Child |
| Interventions | Audiovisual association capability tests (Behavioral) |
| Dates | start 2026-01-01 (estimated), primary completion 2026-01-01 (estimated), completion 2029-09-30 (estimated), first posted 2025-11-24, last updated 2025-11-24 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Premature Baby All trials for Neurocognition, Child All trials of Audiovisual association capability tests
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...)
| Arm | Type | Interventions | Description |
|---|---|---|---|
| premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center | Experimental | 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. |
Sex: All, ages: 4 Months to 35 Weeks
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
| Facility | City | Country | Status |
|---|---|---|---|
| University Hospital Grenoble | Grenoble | France |