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Clinical Trials/NCT04703010
NCT04703010
Recruiting
N/A

Neonatal Precursors of Neurodevelopment

University Hospital, Caen1 site in 1 country90 target enrollmentMarch 1, 2022
ConditionsPremature Birth

Overview

Phase
N/A
Intervention
Not specified
Conditions
Premature Birth
Sponsor
University Hospital, Caen
Enrollment
90
Locations
1
Primary Endpoint
Frontal-parietal structural connectivity
Status
Recruiting
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2022
End Date
September 1, 2024
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Frontal-parietal structural connectivity

Time Frame: 35 weeks GA

Tractography using Diffusion tensor Imaging in magnetic resonance imaging

Frontal-parietal functional connectivity

Time Frame: 35 weeks GA

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

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)

Electroencephalography evoked response amplitude

Time Frame: 35 weeks of gestational age

Electrical field potential changes in the parietal and frontal cortices

Near infrared spectroscopy evoked response amplitude

Time Frame: 35 weeks of gestational age

Oxygenated hemoglobin concentration changes in the somatosensory cortex

Grey matter volume in the somatosensory cortex

Time Frame: 35 weeks GA

Thickness measured on T2 images in magnetic resonance imaging

Study Sites (1)

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