Clinical trial NCT05397197: Impact of Moderate Preterm Birth on Vocabulary Acquisition
Official title: A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: speech acquisition
prematurity
sounds processing
EEG
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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,

Primary outcomes:
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 40 amenorrhea weeks
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 3 months
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 6 months
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 10 months
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 18 months
measure: Study the impact of moderate prematurity on speech encoding characteristics development
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Service de Neuropédiatrie
Study officials:
affiliation: AP-HM
name: Francois Cremieux
role: STUDY_DIRECTOR
References: