Visual Perception in Preterm Infants

Pediatrics Clinical Trial

— PREMAVISION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02908113
• Other study ID #: 6123
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2016
• Last updated: October 16, 2017
• Start date: September 2015
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: University Hospital, Strasbourg, France
• Contact: Claire KOENIG ZORES, MD
• Phone: 03.88.12.77.86
• Email: claire.KOENIG[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 42 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Pediatrics

Intervention

Behavioral:
• collection data

• IRM

Locations

Country	Name	City	State
France	Les Hôiptaux Universitaires	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

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