Impact of Moderate Preterm Birth on Vocabulary Acquisition

Not Applicable

Recruiting

• Conditions: Premature Birth
• Interventions: Other: Electroencephalography

• Registration Number: NCT05397197
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-21
• Study First Submitted QC: 2022-05-25
• Study First Posted: 2022-05-31
• Study Start: 2022-10-19
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-08
• Primary Completion: 2025-10-18
• Study Completion: 2027-10-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Longitudinal follow-up	Electroencephalography	Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months

Primary Outcome Measures

Name	Time	Method
Study the impact of moderate prematurity on speech encoding characteristics development	24 months	Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography

Trial Locations

Locations (1)

Service de Neuropédiatrie; 🇫🇷 Marseille, France