NCT04703010

Neonatal Precursors of Neurodevelopment

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth

Interventions

Type	Name	Description
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.
DEVICE	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)

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2021-01-11
• Last updated: 2022-03-22

Locations

1 site across 1 country: France