Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2015-09-30
2018-12-31
Brief Summary
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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
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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preterm infants
physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated
collection data
IRM
term infants
physiological data collection, behavioral, cerebral hemodynamics, physical environmental newborns studied in response to visual stimuli / auditory or visual-auditory calibrated
collection data
IRM
Interventions
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collection data
IRM
Eligibility Criteria
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Inclusion Criteria
* Consent obtained from both parents
* Social insurance coverage
Exclusion Criteria
* 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
23 Weeks
42 Weeks
ALL
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Claire KOENIG ZORES, MD
Role: PRINCIPAL_INVESTIGATOR
Les Hôpitaux Universitaires de Strasbourg
Locations
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Les Hôiptaux Universitaires
Strasbourg, , France
Countries
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Central Contacts
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Facility Contacts
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claire KOENIG ZORES, MD
Role: primary
Other Identifiers
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6123
Identifier Type: -
Identifier Source: org_study_id