Neonatal Precursors of Neurodevelopment (NEOPRENE)

March 8, 2022 updated by: University Hospital, Caen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Preterm newborn (born < 34 weeks + 6days)

Exclusion Criteria:

  • Brain injury
  • Respiratory assistance on measurement day
  • Infection on measurement day
  • Sedation on measurement day
  • Parents < 18 years old or unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All participants
All participants undergo the same measurements (longitudinal design)
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography evoked response amplitude
Time Frame: 35 weeks of gestational age
Electrical field potential changes in the parietal and frontal cortices
35 weeks of gestational age
Near infrared spectroscopy evoked response amplitude
Time Frame: 35 weeks of gestational age
Oxygenated hemoglobin concentration changes in the somatosensory cortex
35 weeks of gestational age
Grey matter volume in the somatosensory cortex
Time Frame: 35 weeks GA
Thickness measured on T2 images in magnetic resonance imaging
35 weeks GA
Frontal-parietal structural connectivity
Time Frame: 35 weeks GA
Tractography using Diffusion tensor Imaging in magnetic resonance imaging
35 weeks GA
Frontal-parietal functional connectivity
Time Frame: 35 weeks GA
Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging
35 weeks GA
Quality of cognitive development
Time Frame: 2 years old
Qualitative composite assessment using clinical interview, routine pediatric screening and questionnaires (full sensory profile, preschooler Behavior Rating Inventory of Executive Function)
2 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

September 1, 2024

Study Registration Dates

First Submitted

January 4, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 11, 2021

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-A02117-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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