Visual Perception in Preterm Infants (PREMAVISION)

University Hospital, Strasbourg, France

Status: Unknown

Conditions: Pediatrics

Treatments: Behavioral: collection data; Behavioral: IRM

Study type: Interventional

Funder types: Other

Identifiers

NCT02908113

6123

Details and patient eligibility

About

We aim to increase our knowledge of the impact of preterm birth on the maturation of the visual and auditory systems and on the development of multisensory perception

Specifically, we aim to evaluate the preterm infants' capabilities of detection and discrimination of different visual and auditory stimuli according to gestational age, post menstrual age and the duration of the postnatal life.

A secondary aim is to compare this competencies in preterm and full term control art term equivalent age.

The final aim is to optimize the hospital environment in order to make it correspond to the expectations and sensory abilities of very preterm infants.

Our hypothesis is that preterm birth exposes the infants to numerous atypical stimuli which could accelerate the processes of sensory maturation

Enrollment: 150 estimated patients

Sex: All

Ages: 23 to 42 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn less than 32 weeks PMA hospitalized in the Hospital of Hautepierre, Strasbourg, France)
• Consent obtained from both parents
• Social insurance coverage

Exclusion criteria

• Any known malformation
• Brain lesions discovered on brain ultrasound (Intra-Ventricular hemorrhage grade III or IV periventricular Leukomalacia).
• Unstable clinical State
• Retinopathy Of Prematurity stage> 2 or in zone 1
• Family history of abnormal color vision.
• Abnormalities in auditory testing
• Transfer to another hospital expected before 40 week PMA

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

preterm infants

Other group

Description:

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

Treatment:

Behavioral: collection data

Behavioral: IRM

term infants

Other group

Description:

physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

Treatment:

Behavioral: collection data

Behavioral: IRM