NCT04703010

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 11, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

January 4, 2021

Last Update Submit

March 8, 2022

Conditions

Premature Birth

Outcome Measures

Primary Outcomes (6)

  • Electroencephalography evoked response amplitude

    Electrical field potential changes in the parietal and frontal cortices

    35 weeks of gestational age

  • Near infrared spectroscopy evoked response amplitude

    Oxygenated hemoglobin concentration changes in the somatosensory cortex

    35 weeks of gestational age

  • Grey matter volume in the somatosensory cortex

    Thickness measured on T2 images in magnetic resonance imaging

    35 weeks GA

  • Frontal-parietal structural connectivity

    Tractography using Diffusion tensor Imaging in magnetic resonance imaging

    35 weeks GA

  • Frontal-parietal functional connectivity

    Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging

    35 weeks GA

  • 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)

    2 years old

Study Arms (1)

All participants

EXPERIMENTAL

All participants undergo the same measurements (longitudinal design)

Device: Electroencephalography-Near infrared spectroscopyDevice: Magnetic resonance imagingBehavioral: Psychometric testing

Interventions

Electroencephalography-Near infrared spectroscopyDEVICE

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.

All participants
Magnetic resonance imagingDEVICE

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)

All participants
Psychometric testingBEHAVIORAL

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)

All participants

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, 13032, France

RECRUITING

Related Links

MeSH Terms

Conditions

Premature Birth

Interventions

Magnetic Resonance ImagingPsychometrics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisPsychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Longitudinal study with measures at birth and at age 2.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2021

First Posted

January 11, 2021

Study Start

March 1, 2022

Primary Completion

June 1, 2024

Study Completion

September 1, 2024

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)