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Visual Maturation in Premature Newborns According to Factors Influencing Its Development (PREMAVISION)

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ClinicalTrials.gov Identifier: NCT02890251
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease
Delayed Visual Maturation

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Study Type : Observational
Actual Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Visual Maturation in Premature Newborns According to Factors Influencing Its Development
Study Start Date : February 2016
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Control of the Retina by Retinal Camera [ Time Frame: Baseline ]
    Use of Retcam to diagnose Retinopathy of Prematurity - The measurement will be done at the term equivalent age : at the inclusion

  2. Measurement of cycloplegic refraction by mydriaticum 0.5% [ Time Frame: Baseline ]
    The measurement will be done at the term equivalent age : at the inclusion

  3. Presence, absence of light reflex by clinical evaluation [ Time Frame: Baseline ]
    The measurement will be done at the term equivalent age : at the inclusion

  4. Presence, absence or abnormality of visual fixation by clinical observation [ Time Frame: Baseline ]
    The measurement will be done at the term equivalent age : at the inclusion

  5. Analysis of visual cortex with MRI [ Time Frame: Baseline ]
    Determinants of indices of cerebral volume in former very premature infants and their relation to visual maturation. The measurement will be done at the term equivalent age : at the inclusion



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Ages Eligible for Study:   6 Weeks to 10 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy, evaluated at term equivalent age.
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

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): NCT02890251


Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Jean-Michel HASCOET, Pr Maternité Régionale Universitaire A. Pinard CHRU Nancy
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02890251    
Other Study ID Numbers: PSS2016/PREMAVISION-HASCOET/VS
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Central Hospital, Nancy, France:
Infant
Premature
Diseases
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications