Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Visual Perception in Preterm Infants (PREMAVISION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02908113
Recruitment Status : Unknown
Verified October 2016 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
First Posted : September 20, 2016
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment Phase
Pediatrics Behavioral: collection data Behavioral: IRM Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sensory Maturation of Preterm Infants: From Visual Sensitivity to Multisensory Perception
Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. 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

  2. auditory stimulus detection with parents voice [ Time Frame: 3 months ]
    use parents voice, pure sound of 500 Hz


Secondary Outcome Measures :
  1. behavioral responsiveness to visual stimuli calibrated collected from video recordings [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Weeks to 42 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908113


Contacts
Layout table for location contacts
Contact: Claire KOENIG ZORES, MD 03.88.12.77.86 claire.KOENIG@chru-strasbourg.fr
Contact: Pierre KUHN, MD 03 88 12 77 76 Pierre.Kuhn@chru-strasbourg.fr

Locations
Layout table for location information
France
Les Hôiptaux Universitaires Recruiting
Strasbourg, France, 67091
Contact: claire KOENIG ZORES, MD    03.88.12.77.86    claire.KOENIG@chru-strasbourg.fr   
Principal Investigator: Claire KOENIG ZORES, MD         
Sub-Investigator: Pierre KUHN, MD         
Sub-Investigator: Dominique ASTRUC, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Layout table for investigator information
Principal Investigator: Claire KOENIG ZORES, MD Les Hôpitaux Universitaires de Strasbourg

Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT02908113    
Other Study ID Numbers: 6123
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No