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Impact of Moderate Preterm Birth on Vocabulary Acquisition (BABYLANG)

Primary Purpose

Premature Birth

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalography
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Birth focused on measuring speech acquisition, prematurity, sounds processing, EEG

Eligibility Criteria

0 Days - 2 Years (Child)All SexesAccepts Healthy Volunteers

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,

Sites / Locations

  • Service de NeuropédiatrieRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Longitudinal follow-up

Arm Description

Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months

Outcomes

Primary Outcome Measures

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
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
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
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
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
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

Secondary Outcome Measures

Full Information

First Posted
May 21, 2022
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT05397197
Brief Title
Impact of Moderate Preterm Birth on Vocabulary Acquisition
Acronym
BABYLANG
Official Title
A Longitudinal Study of the Impact of Moderate Preterm Birth on Cortical and Subcortical Processing of Speech Sounds and Vocabulary Acquisition
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2022 (Actual)
Primary Completion Date
October 18, 2025 (Anticipated)
Study Completion Date
October 18, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
speech acquisition, prematurity, sounds processing, EEG

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Longitudinal follow-up
Arm Type
Other
Arm Description
Follow-up of children at 40 weeks of corrected age for all children and then regularly until 24 months
Intervention Type
Other
Intervention Name(s)
Electroencephalography
Intervention Description
experimental task, neuropsychological evaluation, clinical exam
Primary Outcome Measure Information:
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Time Frame
40 amenorrhea weeks
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Time Frame
3 months
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Time Frame
6 months
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables, measured by Electroencephalography
Time Frame
10 months
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Time Frame
18 months
Title
Study the impact of moderate prematurity on speech encoding characteristics development
Description
Latency and amplitude of cortical and subcortical auditory evoked potentials in response to syllables , measured by Electroencephalography
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Beatrice Desnous, MD
Phone
04 91 38 73 67
Ext
33
Email
beatrice.desnous@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Cremieux
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Service de Neuropédiatrie
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrice Desnous
Phone
33491386809
Email
beatrice.desnous@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Moderate Preterm Birth on Vocabulary Acquisition

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