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Neonatal Precursors of Neurodevelopment

NCT04703010 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-03-22

No results posted yet for this study

Summary

The NEOPRENE project proposes to examine processes that are among the earliest precursors of cognitive functions and assess 1) the relationship between neonatal cognitive precursors and cortical structure, structural connectivity and functional connectivity at birth and 2) the relationship between neonatal cognitive precursors and neurodevelopment.

Conditions

  • Premature Birth

Interventions

DEVICE

Electroencephalography-Near infrared spectroscopy

Brain activity will be measured using 128-channel EEG and 2 channel NIRS during tactile stimulation (15 minutes sequence of vibrations) while the newborn is asleep.

DEVICE

Magnetic resonance imaging

Structural (T1-T2), siffusion tensor imaging and blood-oxygen level dependant signal will be acquired in a subset of 40 subjects (20 minutes while asleep)

BEHAVIORAL

Psychometric testing

Cognitive evaluation at age 2 (Parental questionnaires on sensory profiles, executive functions and neurodevelopmental disorders screening, child tests : movement assessment battery, Laby, Head-toes-shoulders-knees)

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-06-01
Completion
2024-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04703010 on ClinicalTrials.gov