Early Visual Functions in Patients at Risk of Developing Cerebral Visual Impairment. A Pilot Study

NCT ID: NCT05865093

Last Updated: 2023-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2027-06-30

Brief Summary

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The aim of the study is to assess visual function from neonatal age to 36 months of age in infants at risk of visual impairment due to brain lesion or ocular pathology

Detailed Description

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Conditions

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Visual Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

* Age between 34 weeks of post-menstrual age and 36 months of life in children born before 37 weeks gestational age
* Genetic syndroms
* Hypoxic Hischemic Encephalopathy
* Brain malformation
* Metabolic diseases
* Ocular pathologies

Exclusion Criteria

* Patients at low risk of developing neurological outcomes
* Refusal of informed consent
Minimum Eligible Age

2 Days

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Ricci Daniela

Principal Investigator Pediatric Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Gemelli

Rome, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniela Ricci, Medical Doctor

Role: CONTACT

+393929477842

Facility Contacts

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Daniela Ricci

Role: primary

+393929477842

Other Identifiers

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5006

Identifier Type: -

Identifier Source: org_study_id

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