Visual Maturation in Premature Newborns According to Factors Influencing Its Development

Delayed Visual Maturation Clinical Trial

— PREMAVISION  

Official title:

Visual Maturation in Premature Newborns According to Factors Influencing Its Development

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890251
• Other study ID #: PSS2016/PREMAVISION-HASCOET/VS
• Status: Completed
• Start date: February 1, 2016
• Est. completion date: August 31, 2016

Study information

• Verified date: February 2023
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: August 31, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Weeks to 10 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Delayed Visual Maturation
• Premature Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Secondary	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	Baseline
Secondary	Measurement of cycloplegic refraction by mydriaticum 0.5%	The measurement will be done at the term equivalent age : at the inclusion	Baseline
Secondary	Presence, absence of light reflex by clinical evaluation	The measurement will be done at the term equivalent age : at the inclusion	Baseline
Secondary	Presence, absence or abnormality of visual fixation by clinical observation	The measurement will be done at the term equivalent age : at the inclusion	Baseline
Secondary	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	Baseline