Impact of Moderate Preterm Birth on Vocabulary Acquisition

Premature Birth Clinical Trial

— BABYLANG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05397197
• Other study ID #: 2021-24
• Secondary ID: 2021-A02615-36
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2022
• Est. completion date: October 18, 2027

Study information

• Verified date: January 2024
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Beatrice Desnous, MD
• Phone: 04 91 38 73 67
• Email: beatrice.desnous[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: October 18, 2027
• Est. primary completion date: October 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 2 Years

Eligibility

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,

Related Conditions & MeSH terms

• Premature Birth

Intervention

Other:
• Electroencephalography
experimental task, neuropsychological evaluation, clinical exam

Locations

Country	Name	City	State
France	Service de Neuropédiatrie	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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