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Clinical Trials/NCT02908113
NCT02908113
Unknown
Not Applicable

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

University Hospital, Strasbourg, France1 site in 1 country150 target enrollmentSeptember 2015
ConditionsPediatrics

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pediatrics
Sponsor
University Hospital, Strasbourg, France
Enrollment
150
Locations
1
Primary Endpoint
visual stimulus detection with luminance
Last Updated
8 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Strasbourg, France
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

visual stimulus detection with luminance

Time Frame: 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

Time Frame: 3 months

use parents voice, pure sound of 500 Hz

Secondary Outcomes

  • behavioral responsiveness to visual stimuli calibrated collected from video recordings(3 months)

Study Sites (1)

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