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Clinical Trials/NCT02890251
NCT02890251
Completed
Not Applicable

Visual Maturation in Premature Newborns According to Factors Influencing Its Development

Central Hospital, Nancy, France0 sites69 target enrollmentFebruary 1, 2016
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ConditionsDelayed Visual Maturation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delayed Visual Maturation
Sponsor
Central Hospital, Nancy, France
Enrollment
69
Primary Endpoint
Measurement of Visual Acuity by Baby Vision Cards
Status
Completed
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

The purpose is to describe the level of visual maturation of premature newborns at term equivalent age.

The secondary purpose is to determine factors associated to an altered level of visual maturation, through an exploratory approach.

Registry
clinicaltrials.gov
Start Date
February 1, 2016
End Date
August 31, 2016
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • •Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy

Exclusion Criteria

  • •Parental opposition
  • •Ocular malformation
  • •Face malformation
  • •Cranial stenosis
  • •Chromosomal abnormality

Outcomes

Primary Outcomes

Measurement of Visual Acuity by Baby Vision Cards

Time Frame: Baseline

Baby Vision cards are the French equivalent of Teller Cards - The measurement will be done at the term equivalent age : at the inclusion

Secondary Outcomes

  • Presence, absence of light reflex by clinical evaluation(Baseline)
  • Presence, absence or abnormality of visual fixation by clinical observation(Baseline)
  • Control of the Retina by Retinal Camera(Baseline)
  • Measurement of cycloplegic refraction by mydriaticum 0.5%(Baseline)
  • Analysis of visual cortex with MRI(Baseline)

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