Plasticity of Neonatal Neuronal Networks Temporal Theta A... | NCT03677908

Studies
Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous

NCT03677908

Sponsor

Centre Hospitalier Universitaire, Amiens

Status

Completed

Last Update Posted

Jun 16, 2026Actual

Enrollment

28Actual

Phase

Not provided

Conditions

Premature Birth

Interventions

ElectroEncephaloGraphy

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2016Actual

Primary Completion Date

Jan 1, 2017Actual

Completion Date

Jan 1, 2017Actual

First Submitted Date

Sep 14, 2018

First Submission Date that Met QC Criteria

Sep 18, 2018

First Posted Date

Sep 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2026

Last Update Posted Date

Jun 16, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
13 high		High-Density ElectroEncephaloGraphy analysis of 13 healthy premature infants	Other: ElectroEncephaloGraphy
15 low		Low-Density ElectroEncephaloGraphy analysis of other 15 healthy premature infants	Other: ElectroEncephaloGraphy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ElectroEncephaloGraphy	Other	Density ElectroEncephaloGraphy analysis	13 high 15 low

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
specific temporal TTA-SW	The objective of this study is to evaluate the spatial organization of the specific Temporal theta slow-wave activity (TTA-SW) with the Low-Density Electroencephalography (LD-EEG) at an early stage of development in humans to demonstrate that TTA-SW were independent of auditory stimuli.	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy premature infants
Gestational Ages of 26 and 32 wGA

Exclusion Criteria:

unhealthy premature infants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

28 healthy premature infants follow-up between the Gestational Ages of 26 and 32 wGA between December 2014 and June 2015. These infants were divided into two groups accord- ing to age (26-30 wGA and 30-32 wGA).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fabrice Wallois, PU-PH	CHU AMIENS	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Amiens		80054	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided