Visual Maturation in Premature Newborns According to Factors Influencing Its Development

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.

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Key information

Conditions

Delayed Visual Maturation Disease Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Urogenital Diseases

Age range

6 week–10 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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
Measurement of cycloplegic refraction by mydriaticum 0.5%

Time frame: Baseline

The measurement will be done at the term equivalent age : at the inclusion
Presence, absence of light reflex by clinical evaluation

Time frame: Baseline

The measurement will be done at the term equivalent age : at the inclusion
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
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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: PREMAVISION

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Sep 7, 2016
Registry last updated: Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed