Neonatal Precursors of Neurodevelopment (NEOPRENE)

Caen University Hospital

Status: Enrolling

Conditions: Premature Birth

Treatments: Device: Magnetic resonance imaging; Behavioral: Psychometric testing; Device: Electroencephalography-Near infrared spectroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT04703010

2020-A02117-32

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

All participants

Experimental group

Description:

All participants undergo the same measurements (longitudinal design)

Treatment:

Device: Electroencephalography-Near infrared spectroscopy

Behavioral: Psychometric testing

Device: Magnetic resonance imaging