Study Stopped
Principal Investigator not available anymore (Sabbatical)
Premavision Cohort Follow-up
PrmvsionSuiv
Visual Maturation in Prematurely Born Infants According to Factors Influencing Its Development. Premavision Follow-up at 18 Months Corrected Age, 4 and 7 Years of Age.
1 other identifier
interventional
37
1 country
1
Brief Summary
This study aim at following a cohort of prematurely born infants at 18 months corrected age, 4 and 7 years of age. This cohort had an evaluation of visual maturation at term equivalent age (TEA) with factors associated with impaired visual maturation. (PREMAVISION-CLinicalTrials.gov ID: NCT02890251). In this follow-up study, prematurely born infants vision will be compared to term born infants matched for postnatal age.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 2, 2017
CompletedStudy Start
First participant enrolled
November 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedAugust 13, 2021
August 1, 2021
2.6 years
June 30, 2017
August 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Visual acuity measurement
Baby Vision Cards
18 months corrected age
Visual acuity measurement
Rossano Weiss test
4 years post-natal age
Visual acuity measurement
Parinaud and Snellen tests
7 years post-natal age
Secondary Outcomes (3)
Measurement of cyclopegic refraction
18 months corrected age
Measurement of cyclopegic refraction
4 years of age
Measurement of cyclopegic refraction
7 years of age
Study Arms (2)
Prematurely born infants
EXPERIMENTALVisual acuity measurement in prematurely born infants included in PREMAVISION study
Term born infants
ACTIVE COMPARATORVisual acuity measurement in term born control infants
Interventions
visual acuity measurement by Baby Vision cards at 18 months corrected age, by Rossano Weiss test at 4 years of age and optometric tests of Parinaud and Snellen at 7 years of age
Eligibility Criteria
You may qualify if:
- Infants included in the Premavision cohort
- Term born healthy control infants at matched postnatal age
You may not qualify if:
- Ocular malformation
- Genetic abnormality
- Neurodevelopmental impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maternity Hospital CHRU
Nancy, 54035, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 2, 2017
Study Start
November 20, 2017
Primary Completion
June 30, 2020
Study Completion
June 30, 2021
Last Updated
August 13, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share