BABYLANG: Impact of Moderate Preterm Birth on Vocabulary Acquisition

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05397197

Collaborator

(none)

160

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Premature Birth	Other: Electroencephalography	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Study the impact of moderate prematurity on speech encoding characteristics development [40 amenorrhea weeks]
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development [3 months]
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development [6 months]
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development [10 months]
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Study the impact of moderate prematurity on speech encoding characteristics development [18 months]
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Days to 2 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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,

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Francois Cremieux, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT05397197

Other Study ID Numbers:

2021-24
2021-A02615-36

First Posted:

May 31, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique Hopitaux De Marseille

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of May 31, 2022