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Neonatal Precursors of Neurodevelopment (NEOPRENE)

Primary Purpose

Premature Birth

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Electroencephalography-Near infrared spectroscopy
Magnetic resonance imaging
Psychometric testing
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Birth

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Caen University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All participants

Arm Description

All participants undergo the same measurements (longitudinal design)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 4, 2021
Last Updated
March 8, 2022
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT04703010
Brief Title
Neonatal Precursors of Neurodevelopment
Acronym
NEOPRENE
Official Title
Neonatal Precursors of Neurodevelopment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal study with measures at birth and at age 2.
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
13032
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadege Roche-Labarbe, PhD
Phone
33 232 568 386
Email
nadege.roche@unicaen.fr
First Name & Middle Initial & Last Name & Degree
Victoria Dumont, PhD
Email
victoria.dumont@unicaen.fr

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://anr.fr/Projet-ANR-19-CE37-0015
Description
funding information

Learn more about this trial

Neonatal Precursors of Neurodevelopment

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