Impact of Moderate Preterm Birth on Vocabulary Acquisition (BABYLANG)

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

Study Overview

• Status: Recruiting
• Conditions: Premature Birth
• Intervention / Treatment: Other: Electroencephalography

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Beatrice Desnous, MD; Phone Number: 33 04 91 38 73 67; Email: beatrice.desnous@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13005
    • Recruiting
    • Service de Neuropédiatrie
    • Contact: Beatrice Desnous; Phone Number: 33491386809; Email: beatrice.desnous@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Longitudinal follow-up; Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months	Other: Electroencephalography; experimental task, neuropsychological evaluation, clinical exam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	40 amenorrhea weeks
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	3 months
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	6 months
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	10 months
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	18 months
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	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François CREMIEUX, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Estimated): October 19, 2028
• Study Completion (Estimated): October 19, 2030

Study Registration Dates

• First Submitted: May 21, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: EEG; prematurity; speech acquisition; sounds processing
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: 2021-24; 2021-A02615-36 (Registry Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No