Impact of Moderate Preterm Birth on Vocabulary Acquisition
ConditionPremature Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-2
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Neonatal distress (Apgar score < 7)
Hypoxic and ischemic encephalopathy
Perinatal acidosis
Intrauterine growth retardation
Trial design
Design model
Single group
Treatments tested in this trial
Electroencephalography
Other interventionexperimental task, neuropsychological evaluation, clinical exam
Treatment groups
160 Participants
are divided into 1 treatment groupGroup A: Longitudinal follow-upOther 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
40 amenorrhea weeks2
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
Time frame
3 months3
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
Time frame
6 months4
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
Time frame
10 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov