Delayed Visual MaturationPREMAVISIONNCT02890251
Visual Maturation in Premature Newborns According to Factors Influencing Its Development
An observational study of Delayed Visual Maturation, run by Central Hospital, Nancy, France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 10 weeks
- Conditions the study is for
- Delayed Visual Maturation
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 31 Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy, evaluated at term equivalent age.
Who may be able to join
- Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy
Who cannot join
- Parental opposition
- Ocular malformation
- Face malformation
- Cranial stenosis
- Chromosomal abnormality
About this study
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.
- Conditions
- Delayed Visual Maturation
- Keywords
- Infant, Premature, Diseases
- Medical subject headings
- Premature Birth, Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Visual Acuity by Baby Vision Cards
Baby Vision cards are the French equivalent of Teller Cards - The measurement will be done at the term equivalent age : at the inclusion
Measured: Baseline
Secondary outcomes (5)
Control of the Retina by Retinal Camera
Use of Retcam to diagnose Retinopathy of Prematurity - The measurement will be done at the term equivalent age : at the inclusion
Measured: Baseline
Measurement of cycloplegic refraction by mydriaticum 0.5%
The measurement will be done at the term equivalent age : at the inclusion
Measured: Baseline
Presence, absence of light reflex by clinical evaluation
The measurement will be done at the term equivalent age : at the inclusion
Measured: Baseline
Presence, absence or abnormality of visual fixation by clinical observation
The measurement will be done at the term equivalent age : at the inclusion
Measured: Baseline
Analysis of visual cortex with MRI
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start1 Feb 2016
- Primary completion30 Jun 2016
- Study completion31 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Delayed Visual MaturationStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Michel HASCOET, Central Hospital, Nancy, France
- Investigators
- Jean-Michel HASCOET, Pr, Principal investigator, Maternité Régionale Universitaire A. Pinard CHRU Nancy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890251
- Sponsor's protocol ID
- PSS2016/PREMAVISION-HASCOET/VS
- Acronym
- PREMAVISION
- Status last verified
- Feb 2023
- First submitted
- 18 Aug 2016
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wirth M, Naud A, Schmitt E, Clerc-Urmes I, Hascoet JM. Visual Maturation at Term Equivalent Age in Very Premature Infants According to Factors Influencing Its Development. Front Physiol. 2018 Nov 20;9:1649. doi: 10.3389/fphys.2018.01649. eCollection 2018.
PubMed 30515105
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Maturation in Premature Newborns According to Factors Influencing Its Development
- ClinicalTrials.gov ID
- NCT02890251
- Acronym / sponsor ID
- PREMAVISION / PSS2016/PREMAVISION-HASCOET/VS
- Conditions
- Delayed Visual Maturation
- Keywords
- Infant, Premature, Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Feb 2016
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Premature babies, born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy, evaluated at term equivalent age.
Key inclusion criteria (1 listed)
- Infants born before 33 weeks of amenorrhea and hospitalized at CHRU Nancy
Key exclusion criteria (5 listed)
- Parental opposition
- Ocular malformation
- Face malformation
- Cranial stenosis
- Chromosomal abnormality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Control of the Retina by Retinal Camera
Time frame: Baseline
Measurement of cycloplegic refraction by mydriaticum 0.5%
Time frame: Baseline
Presence, absence of light reflex by clinical evaluation
Time frame: Baseline
Presence, absence or abnormality of visual fixation by clinical observation
Time frame: Baseline
Analysis of visual cortex with MRI
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 30515105Wirth M, Naud A, Schmitt E, Clerc-Urmes I, Hascoet JM. Visual Maturation at Term Equivalent Age in Very Premature Infants According to Factors Influencing Its Development. Front Physiol. 2018 Nov 20;9:1649. doi: 10.3389/fphys.2018.01649. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Michel HASCOET, Pr principal investigator
Maternité Régionale Universitaire A. Pinard CHRU Nancy
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Visual Maturation, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Visual Acuity by Baby Vision Cards (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02890251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.