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NCT04703010 Clinical Trial

Neonatal Precursors of Neurodevelopment

Premature Birth Clinical Trial

— NEOPRENE  

Official title:
Neonatal Precursors of Neurodevelopment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04703010
Other study ID # 2020-A02117-32
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2022
Est. completion date September 1, 2024

Study information
Verified date March 2022
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date September 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.
• 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)

Locations
Country Name City State
France Caen University Hospital Caen

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Electroencephalography evoked response amplitude Electrical field potential changes in the parietal and frontal cortices 35 weeks of gestational age
Primary Near infrared spectroscopy evoked response amplitude Oxygenated hemoglobin concentration changes in the somatosensory cortex 35 weeks of gestational age
Primary Grey matter volume in the somatosensory cortex Thickness measured on T2 images in magnetic resonance imaging 35 weeks GA
Primary Frontal-parietal structural connectivity Tractography using Diffusion tensor Imaging in magnetic resonance imaging 35 weeks GA
Primary Frontal-parietal functional connectivity Synchronization at rest using blood-oxygen level dependent signal in magnetic resonance imaging 35 weeks GA
Primary 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
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