Visual Perception in Preterm Infants

Not Applicable

• Conditions: Pediatrics
• Interventions: Behavioral: collection data; Behavioral: IRM

• Registration Number: NCT02908113
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-08-26
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-20
• Status Verified: 2016-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-17
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preterm infants	IRM	physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated
term infants	IRM	physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated
preterm infants	collection data	physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated
term infants	collection data	physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated

Primary Outcome Measures

Name	Time	Method
visual stimulus detection with luminance	3 months	in "green" condition in hospital, luminance ( 100 and 300 lux ) and color (blue- red-yellow- white) variables
auditory stimulus detection with parents voice	3 months	use parents voice, pure sound of 500 Hz

Secondary Outcome Measures

Name	Time	Method
behavioral responsiveness to visual stimuli calibrated collected from video recordings	3 months	Evaluate the facial expression of the imitation abilities in preterm and term neonates at term. The interpretation of the behavioral responses of newborns to mimic presented by the experimenter will be working independently by two observers with a coding grid

Trial Locations

Locations (1)

Les Hôiptaux Universitaires; 🇫🇷 Strasbourg, France