Premature BirthBABYLANGNCT05397197
Impact of Moderate Preterm Birth on Vocabulary Acquisition
A study testing Electroencephalography in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea. Read more about this study
- Who is it for?
- Ages 0 days to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- Electroencephalography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2022to 19 Oct 2030
- 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 0 days to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA)
- Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference)
- Normal clinical examination at inclusion.
- Written informed consent obtained from both parents (or single parent if single parent)
- Infant with at least one parent who speaks and understands fluent French
- Infant is affiliated with the social security system
- Infant whose parents reside in Marseille
Who cannot join
- Neonatal distress (Apgar score < 7)
- Hypoxic and ischemic encephalopathy
- Perinatal acidosis
- Intrauterine growth retardation
- Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia)
- Cerebral congenital malformations
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- Neonatal epilepsy
- Any condition that in the opinion of the investigator would not be compatible with the conduct of this study
- Abnormal hearing test performed as part of the child's routine care at birth,
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, 1 recruiting
- Recruiting
Service de Neuropédiatrie
Marseille, 13005
Beatrice Desnous, 33491386809, beatrice.desnous@ap-hm.fr
About this study
Official title: A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea.
In our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding.
The identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.
- Conditions
- Premature Birth
- Being tested
- Electroencephalography
- Keywords
- speech acquisition, prematurity, sounds processing, EEG
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyOther
experimental task, neuropsychological evaluation, clinical exam
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal follow-up | Other | Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months Receives: Other: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Measured: 40 amenorrhea weeks
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Measured: 3 months
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Measured: 6 months
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Measured: 10 months
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Measured: 18 months
Study the impact of moderate prematurity on speech encoding characteristics development
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start19 Oct 2022
- Primary completion19 Oct 2028 (estimated)
- Study completion19 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Cremieux, Study director, AP-HM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397197
- Sponsor's protocol ID
- 2021-24
- Other IDs
- 2021-A02615-36
- Acronym
- BABYLANG
- Status last verified
- Jan 2026
- First submitted
- 21 May 2022
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
- ClinicalTrials.gov ID
- NCT05397197
- Acronym / sponsor ID
- BABYLANG / 2021-24
- Conditions
- Premature Birth
- Keywords
- speech acquisition, prematurity, sounds processing, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 19 Oct 2022 (actual)
- Primary completion
- 19 Oct 2028 (estimated)
- Study completion
- 19 Oct 2030 (estimated)
- First posted
- 31 May 2022 (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.
Children born prematurely may present a neurodevelopmental disorder with a language delay diagnosed as early as 2-3 years of age. This situation is not uncommon: each year in France, approximately 35,000 children are born between 32 and 36 weeks of amenorrhea.
In our most recent work, we have shown that moderate premature infants show an attenuated cortical response to a vowel change, suggesting a deficit in the cortical encoding of vowels. This work needs to be continued in order to better understand syllable encoding and identify the neuroplasticity mechanisms underlying early speech encoding.
The identification of markers to predict language development is essential for the screening of these children at risk of language delay. These children could thus benefit from early adapted care even before the appearance of language deficits.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Longitudinal follow-up | Other | Other: ElectroencephalographyFollow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months |
Who may qualify
- Ages
- 0 days to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants born prematurely (32-36 weeks gestational age, GA) or at term (40-2 weeks gestational age, GA)
- Birth weight appropriate to gestational age determined by WHO growth charts (weight, height, head circumference)
- Normal clinical examination at inclusion.
- Written informed consent obtained from both parents (or single parent if single parent)
- Infant with at least one parent who speaks and understands fluent French
Key exclusion criteria (9 listed)
- Neonatal distress (Apgar score < 7)
- Hypoxic and ischemic encephalopathy
- Perinatal acidosis
- Intrauterine growth retardation
- Brain injury (such as intraventricular or periventricular hemorrhage, periventricular leukomalacia)
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 |
|---|---|---|
| Electroencephalographyexperimental task, neuropsychological evaluation, clinical exam | Other | Longitudinal follow-up |
Primary outcome
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 40 amenorrhea weeks
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 3 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 6 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 10 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 18 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development
Time frame: 24 months
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
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 8 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Francois Cremieux study director
AP-HM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroencephalography in people with Premature Birth, run by Assistance Publique Hopitaux De Marseille 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 7 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 8 Jan 2026. 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 Beatrice Desnous, MD (04 91 38 73 67 ext. 33, beatrice.desnous@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the impact of moderate prematurity on speech encoding characteristics development (time frame: 40 amenorrhea weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jan 2026.