Premature BabyPré-AVNCT07245693
Longitudinal Assessment of Early Premature Infant Skills for Audiovisual Speech Perception
A study testing Audiovisual association capability tests in people with Premature Baby and Neurocognition, Child, run by University Hospital, Grenoble at 1 site in France.
Trial 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.) . Read more about this study
- Who is it for?
- Ages 4 months to 35 weeks
- Conditions the study is for
- Premature Baby, Neurocognition, Child
- What is being tested?
- Audiovisual association capability tests
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 30 Sep 2029
- Phase
- Interventional
- 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 4 months to 35 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Severe retinopathies
- Severe neurological damage (grade 3 and 4 intraventricular hemorrhage and periventricular cavity leucomalacia)
- Inconclusive hearing tests
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Hospital Grenoble
Grenoble
Alice De Martin Du Tyrac De Marcellu, medical intern, +33476765577, ADemartindutyracdem@chu-grenoble.fr
Noëlle BROSILLE, +33476767132, NBrosille@chu-grenoble.fr
About this study
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.
Read more
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...)
- Conditions
- Premature Baby, Neurocognition, Child
- Being tested
- Audiovisual association capability tests
- Keywords
- perception, premature, speech, audiovisual, early skills, nourisson, corrected age, real age, associate, visual speech, auditory speech, language development, aquisition, vocabulary, language difficulties, ASD, capacity, language delay
- Medical subject headings
- Premature Birth, Speech, Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual association capability testsBehavioural
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 group | Role | What they receive |
|---|---|---|
| premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center | Experimental | 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. Receives: Behavioral: Audiovisual association capability tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 16 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Premature BabyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Dr Chevallier, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245693
- Sponsor's protocol ID
- 38RC24.0246
- Other IDs
- 2025-A00773-46
- Acronym
- Pré-AV
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: confidentiel data
Publications
Imafuku M, Kawai M, Niwa F, Shinya Y, Myowa M. Audiovisual speech perception and language acquisition in preterm infants: A longitudinal study. Early Hum Dev. 2019 Jan;128:93-100. doi: 10.1016/j.earlhumdev.2018.11.001. Epub 2018 Dec 9.
PubMed 30541680van Noort-van der Spek IL, Franken MC, Weisglas-Kuperus N. Language functions in preterm-born children: a systematic review and meta-analysis. Pediatrics. 2012 Apr;129(4):745-54. doi: 10.1542/peds.2011-1728. Epub 2012 Mar 19.
PubMed 22430458Arunachalam S, Luyster RJ. The integrity of lexical acquisition mechanisms in autism spectrum disorders: A research review. Autism Res. 2016 Aug;9(8):810-28. doi: 10.1002/aur.1590. Epub 2015 Dec 21.
PubMed 26688218Irwin JR, Brancazio L. Seeing to hear? Patterns of gaze to speaking faces in children with autism spectrum disorders. Front Psychol. 2014 May 8;5:397. doi: 10.3389/fpsyg.2014.00397. eCollection 2014.
PubMed 24847297Stevenson RA, Siemann JK, Schneider BC, Eberly HE, Woynaroski TG, Camarata SM, Wallace MT. Multisensory temporal integration in autism spectrum disorders. J Neurosci. 2014 Jan 15;34(3):691-7. doi: 10.1523/JNEUROSCI.3615-13.2014.
PubMed 24431427Jones W, Klin A. Attention to eyes is present but in decline in 2-6-month-old infants later diagnosed with autism. Nature. 2013 Dec 19;504(7480):427-31. doi: 10.1038/nature12715. Epub 2013 Nov 6.
PubMed 24196715Weatherhead D, Arredondo MM, Nacar Garcia L, Werker JF. The Role of Audiovisual Speech in Fast-Mapping and Novel Word Retention in Monolingual and Bilingual 24-Month-Olds. Brain Sci. 2021 Jan 16;11(1):114. doi: 10.3390/brainsci11010114.
PubMed 33467100Newman R, Ratner NB, Jusczyk AM, Jusczyk PW, Dow KA. Infants' early ability to segment the conversational speech signal predicts later language development: a retrospective analysis. Dev Psychol. 2006 Jul;42(4):643-55. doi: 10.1037/0012-1649.42.4.643.
PubMed 16802897Bahrick LE, Lickliter R. Learning to Attend Selectively: The Dual Role of Intersensory Redundancy. Curr Dir Psychol Sci. 2014 Dec;23(6):414-420. doi: 10.1177/0963721414549187.
PubMed 25663754Tenenbaum EJ, Sobel DM, Sheinkopf SJ, Shah RJ, Malle BF, Morgan JL. Attention to the mouth and gaze following in infancy predict language development. J Child Lang. 2015 Nov;42(6):1173-90. doi: 10.1017/S0305000914000725. Epub 2014 Nov 18.
PubMed 25403090Teinonen T, Aslin RN, Alku P, Csibra G. Visual speech contributes to phonetic learning in 6-month-old infants. Cognition. 2008 Sep;108(3):850-5. doi: 10.1016/j.cognition.2008.05.009. Epub 2008 Jun 30.
PubMed 18590910Birules J, Goupil L, Josse J, Fort M. The Role of Talking Faces in Infant Language Learning: Mind the Gap between Screen-Based Settings and Real-Life Communicative Interactions. Brain Sci. 2023 Aug 5;13(8):1167. doi: 10.3390/brainsci13081167.
PubMed 37626523Jayaraman S, Smith LB. Faces in early visual environments are persistent not just frequent. Vision Res. 2019 Apr;157:213-221. doi: 10.1016/j.visres.2018.05.005. Epub 2018 Jun 20.
PubMed 29852210
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Early Premature Infant Skills for Audiovisual Speech Perception
- ClinicalTrials.gov ID
- NCT07245693
- Acronym / sponsor ID
- Pré-AV / 38RC24.0246
- Conditions
- Premature Baby, Neurocognition, Child
- Keywords
- perception, premature, speech, audiovisual, early skills, nourisson, corrected age, real age
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center | Experimental | Behavioral: Audiovisual association capability testsVisits 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. |
Who may qualify
- Ages
- 4 months to 35 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Severe retinopathies
- Severe neurological damage (grade 3 and 4 intraventricular hemorrhage and periventricular cavity leucomalacia)
- Inconclusive hearing tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual association capability testsVisits 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. | Behavioural | premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Background: PubMed 30541680Imafuku M, Kawai M, Niwa F, Shinya Y, Myowa M. Audiovisual speech perception and language acquisition in preterm infants: A longitudinal study. Early Hum Dev. 2019 Jan;128:93-100. doi: 10.1016/j.earlhumdev.2018.11.001. Epub 2018 Dec 9.
- Background: PubMed 22430458van Noort-van der Spek IL, Franken MC, Weisglas-Kuperus N. Language functions in preterm-born children: a systematic review and meta-analysis. Pediatrics. 2012 Apr;129(4):745-54. doi: 10.1542/peds.2011-1728. Epub 2012 Mar 19.
- Background: PubMed 26688218Arunachalam S, Luyster RJ. The integrity of lexical acquisition mechanisms in autism spectrum disorders: A research review. Autism Res. 2016 Aug;9(8):810-28. doi: 10.1002/aur.1590. Epub 2015 Dec 21.
- Background: PubMed 24847297Irwin JR, Brancazio L. Seeing to hear? Patterns of gaze to speaking faces in children with autism spectrum disorders. Front Psychol. 2014 May 8;5:397. doi: 10.3389/fpsyg.2014.00397. eCollection 2014.
- Background: PubMed 24431427Stevenson RA, Siemann JK, Schneider BC, Eberly HE, Woynaroski TG, Camarata SM, Wallace MT. Multisensory temporal integration in autism spectrum disorders. J Neurosci. 2014 Jan 15;34(3):691-7. doi: 10.1523/JNEUROSCI.3615-13.2014.
- Background: PubMed 24196715Jones W, Klin A. Attention to eyes is present but in decline in 2-6-month-old infants later diagnosed with autism. Nature. 2013 Dec 19;504(7480):427-31. doi: 10.1038/nature12715. Epub 2013 Nov 6.
- Background: PubMed 33467100Weatherhead D, Arredondo MM, Nacar Garcia L, Werker JF. The Role of Audiovisual Speech in Fast-Mapping and Novel Word Retention in Monolingual and Bilingual 24-Month-Olds. Brain Sci. 2021 Jan 16;11(1):114. doi: 10.3390/brainsci11010114.
- Background: PubMed 16802897Newman R, Ratner NB, Jusczyk AM, Jusczyk PW, Dow KA. Infants' early ability to segment the conversational speech signal predicts later language development: a retrospective analysis. Dev Psychol. 2006 Jul;42(4):643-55. doi: 10.1037/0012-1649.42.4.643.
- Background: PubMed 25663754Bahrick LE, Lickliter R. Learning to Attend Selectively: The Dual Role of Intersensory Redundancy. Curr Dir Psychol Sci. 2014 Dec;23(6):414-420. doi: 10.1177/0963721414549187.
- Background: PubMed 25403090Tenenbaum EJ, Sobel DM, Sheinkopf SJ, Shah RJ, Malle BF, Morgan JL. Attention to the mouth and gaze following in infancy predict language development. J Child Lang. 2015 Nov;42(6):1173-90. doi: 10.1017/S0305000914000725. Epub 2014 Nov 18.
- Background: PubMed 18590910Teinonen T, Aslin RN, Alku P, Csibra G. Visual speech contributes to phonetic learning in 6-month-old infants. Cognition. 2008 Sep;108(3):850-5. doi: 10.1016/j.cognition.2008.05.009. Epub 2008 Jun 30.
- Background: PubMed 37626523Birules J, Goupil L, Josse J, Fort M. The Role of Talking Faces in Infant Language Learning: Mind the Gap between Screen-Based Settings and Real-Life Communicative Interactions. Brain Sci. 2023 Aug 5;13(8):1167. doi: 10.3390/brainsci13081167.
- French adaptations of short versions of MacArthur-Bates communicative inventoriesLink provided by the sponsor.
- Individual participant dataSharing planned: No. confidentiel data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Dr Chevallier principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual association capability tests in people with Premature Baby and Neurocognition, Child, run by University Hospital, Grenoble at 1 site in France.
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 3 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: opening soon, as of the sponsor's last update on 24 Nov 2025. 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 France. 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?
Contact Alice De Martin Du Tyrac De Marcellu (+33476765577, ADemartindutyracdem@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07245693, which also lists 13 linked publications.
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 24 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.