NCT03677908

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2018

Completed
Last Updated

September 19, 2018

Status Verified

September 1, 2018

Enrollment Period

6 months

First QC Date

September 14, 2018

Last Update Submit

September 18, 2018

Conditions

Keywords

Temporoparietal AreasNeural Biomarker

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Density ElectroEncephaloGraphy analysis

13 high15 low

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • healthy premature infants
  • Gestational Ages of 26 and 32 wGA

You may not qualify if:

  • unhealthy premature infants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Fabrice Wallois, MD, PhD

    CHU AMIENS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2018

First Posted

September 19, 2018

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 19, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share