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NCT Number: NCT05397197

Impact of Moderate Preterm Birth on Vocabulary Acquisition

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

0 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Neuropédiatrie

Marseille, 13005, France

Location status: Recruiting

Location contact

Beatrice Desnous

CONTACT

[email protected]

33491386809

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Electroencephalography

Other

experimental task, neuropsychological evaluation, clinical exam

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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 contacts

Contact information is provided by the study sponsor or research team.

Beatrice Desnous, MD

CONTACT

[email protected]

04 91 38 73 67 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Acronym: BABYLANG

Important dates

Study start
2022
Primary completion
2028
Study completion
2030
First posted
May 31, 2022
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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