NCT07245693

Brief 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...)

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
42mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Sep 2029

First Submitted

Initial submission to the registry

November 17, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Expected
Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

Same day

First QC Date

November 17, 2025

Last Update Submit

November 17, 2025

Conditions

Keywords

perceptionprematurespeechaudiovisualearly skillsnourissoncorrected agereal ageassociatevisual speechauditory speechlanguage developmentaquisitionvocabularylanguage difficultiesASDcapacitylanguage delay

Outcome Measures

Primary Outcomes (1)

  • 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.

    From enrollment to the end of treatment at 16 months of life

Study Arms (1)

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.

Behavioral: Audiovisual association capability tests

Interventions

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.

premature child born before 34 weeks of amenorrhea at the Grenoble Alpes Hospital Center

Eligibility Criteria

Age4 Months - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Grenoble

Grenoble, France

Location

Related Publications (13)

  • 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.

    PMID: 30541680BACKGROUND
  • van 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.

    PMID: 22430458BACKGROUND
  • Arunachalam 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.

    PMID: 26688218BACKGROUND
  • Irwin 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.

    PMID: 24847297BACKGROUND
  • Stevenson 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.

    PMID: 24431427BACKGROUND
  • Jones 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.

    PMID: 24196715BACKGROUND
  • Weatherhead 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.

    PMID: 33467100BACKGROUND
  • Newman 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.

    PMID: 16802897BACKGROUND
  • Bahrick 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.

    PMID: 25663754BACKGROUND
  • Tenenbaum 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.

    PMID: 25403090BACKGROUND
  • Teinonen 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.

    PMID: 18590910BACKGROUND
  • Birules 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.

    PMID: 37626523BACKGROUND
  • Jayaraman 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.

    PMID: 29852210BACKGROUND

Related Links

MeSH Terms

Conditions

Premature BirthSpeechLanguage Development Disorders

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVerbal BehaviorCommunicationBehaviorLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marie Dr Chevallier

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice De Martin Du Tyrac De Marcellu

CONTACT

No BROSILLE, medical intern

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2025

First Posted

November 24, 2025

Study Start

January 1, 2026

Primary Completion

January 1, 2026

Study Completion (Estimated)

September 30, 2029

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

confidentiel data

Locations