Visual Perception in Preterm Infants (PREMAVISION)

Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception

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

Study Overview

• Status: Unknown
• Conditions: Pediatrics
• Intervention / Treatment: Behavioral: collection data; Behavioral: IRM

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: claire KOENIG ZORES, MD; Phone Number: 03.88.12.77.86; Email: claire.KOENIG@chru-strasbourg.fr
• Study Contact Backup: Name: Pierre KUHN, MD; Phone Number: 03 88 12 77 76; Email: Pierre.Kuhn@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Recruiting
    • Les Hôiptaux Universitaires
    • Contact: claire KOENIG ZORES, MD; Phone Number: 03.88.12.77.86; Email: claire.KOENIG@chru-strasbourg.fr
    • Principal Investigator: Claire KOENIG ZORES, MD
    • Sub-Investigator: Pierre Kuhn, MD
    • Sub-Investigator: Dominique ASTRUC, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 9 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: preterm infants; physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated	Behavioral: collection data; Behavioral: IRM
Other: term infants; physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated	Behavioral: collection data; Behavioral: IRM

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
behavioral responsiveness to visual stimuli calibrated collected from video recordings	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	3 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Claire KOENIG ZORES, MD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: August 26, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 20, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 16, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 6123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO