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Recruiting NCT05397197

Impact of Moderate Preterm Birth on Vocabulary Acquisition

No phase Interventional Premature Birth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Electroencephalography.
Who it may be relevant to
Registry conditions: Premature Birth. Basic parameters: 0 Days — 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other Electroencephalography
    experimental task, neuropsychological evaluation, clinical exam

Primary outcome measures

  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 40 amenorrhea weeks]
  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 3 months]
  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 6 months]
  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 10 months]
  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 18 months]
  • Study the impact of moderate prematurity on speech encoding characteristics development [Time frame: 24 months]

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,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Service de Neuropédiatrie — Marseille

Identifiers

NCT: NCT05397197 · 2021-24 · 2021-A02615-36

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗