NCT05865093

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
11mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jul 2022Jun 2027

Study Start

First participant enrolled

July 1, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

May 18, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

March 17, 2023

Last Update Submit

May 17, 2023

Conditions

Visual Impairment

Outcome Measures

Primary Outcomes (1)

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

    The score of the functional visual assessment will be obtained at neonatal age and at 1-3-6-9-12-18-24-36 months of life will be analysed at each age and compared to neurodevelopment findings using different scales according to age. These results will be related to the MRI total score (obtained by the sum of scores by site: cortex, basal ganglia, white matter and cerebellum, normal (0), mild abnormal (1), severely abnormal (2)).

    5 years

Secondary Outcomes (1)

  • Correlation betwwen functional visual assessment score to MRI score

    5 years

Eligibility Criteria

Age2 Days - 36 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children at risk for visual impairment due to brain lesion, brain malformation, genetic syndroms, Hypoxic Hischemic Encephalopathy, metabolic diseases or ocular pathologies, assessed at neonatal age and followed up to 36 months of age

You may qualify if:

  • 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

You may not qualify if:

  • Patients at low risk of developing neurological outcomes
  • Refusal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Gemelli

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Vision Disorders

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Daniela Ricci, Medical Doctor

CONTACT

+393929477842d.ricci@iapb.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator Pediatric Neurologist

Study Record Dates

First Submitted

March 17, 2023

First Posted

May 18, 2023

Study Start

July 1, 2022

Primary Completion

September 30, 2023

Study Completion (Estimated)

June 30, 2027

Last Updated

May 18, 2023

Record last verified: 2023-05

Locations

IT(1)