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

February 13, 2023 updated by: Jean-Michel HASCOET, Central Hospital, Nancy, France

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

69

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
Measurement of cycloplegic refraction by mydriaticum 0.5%
Time Frame: Baseline
The measurement will be done at the term equivalent age : at the inclusion
Baseline
Presence, absence of light reflex by clinical evaluation
Time Frame: Baseline
The measurement will be done at the term equivalent age : at the inclusion
Baseline
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
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

August 31, 2016

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS2016/PREMAVISION-HASCOET/VS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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