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Clinical Trials/NCT05397197
NCT05397197
Recruiting
N/A

A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition

Assistance Publique Hopitaux De Marseille2 sites in 1 country160 target enrollmentOctober 19, 2022

Overview

Phase
N/A
Intervention
Electroencephalography
Conditions
Premature Birth
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
160
Locations
2
Primary Endpoint
Study the impact of moderate prematurity on speech encoding characteristics development
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2022
End Date
October 19, 2030
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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,

Arms & Interventions

Longitudinal follow-up

Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months

Intervention: Electroencephalography

Outcomes

Primary Outcomes

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

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 Sites (2)

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