Neonatal Precursors of Neurodevelopment

Not Applicable

Recruiting

• Conditions: Premature Birth
• Interventions: Device: Electroencephalography-Near infrared spectroscopy; Device: Magnetic resonance imaging; Behavioral: Psychometric testing

• Registration Number: NCT04703010
• Lead Sponsor: University Hospital, Caen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-04
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-22
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Psychometric testing	All participants undergo the same measurements (longitudinal design)
All participants	Magnetic resonance imaging	All participants undergo the same measurements (longitudinal design)
All participants	Electroencephalography-Near infrared spectroscopy	All participants undergo the same measurements (longitudinal design)

Primary Outcome Measures

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

Trial Locations

Locations (1)

Caen University Hospital; 🇫🇷 Caen, France