Clinical Trial

Reading-FREE Markers for Early Detection of Developmental Dyslexia

Study acronym: FREE-DD
Enrolling by Invitation
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Record status
This record was last updated July 18, 2025 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
This study aims to identify early signs of developmental dyslexia (DD) and other reading difficulties in children born preterm, using behavioral, cognitive, and brain imaging data collected before reading problems typically become noticeable. Children born very early often face greater risk for reading and learning challenges, but these difficulties are not always detected in time for early support. This research seeks to fill that gap. A group of 30 children born preterm will be followed over time, alongside a control group of 15 children born at term. All children will be assessed during the second and third years of primary school (around ages 6-9). In Grade 2, children will undergo (a) a specially designed digital screening tool for reading difficulties that does not require actual reading (called the RFST), (b) standard tests of reading, language, and attention, and (c) structural and functional brain scans using Magnetic Resonance Imaging (MRI). In Grade 3, the children will be reassessed using the RFST and the cognitive and language tests. The goal is to identify specific behavioral and brain-based markers-particularly patterns of brain connectivity-that are already present in Grade 2 and can predict which children will go on to show reading difficulties in Grade 3. By comparing data from preterm and term-born children, researchers aim to discover early warning signs that are specific to children born preterm. By detecting these risks early, before reading delays become severe, the study hopes to guide new tools for screening and early intervention, tailored specifically to the unique developmental paths of children born preterm. This could help prevent later academic struggles and promote better long-term outcomes.
Trial Details
NCT Number NCT07072104
Lead Sponsor Università Vita-Salute San Raffaele
Collaborators: University of Urbino "Carlo Bo", University of Milano Bicocca
Conditions Preterm Birth, Developmental Dyslexia
Enrollment 45 participants
Start Date 2025-07
Primary Completion 2026-01 (estimated)
Study Completion 2026-02-28 (estimated)
Updated on ClinicalTrials.gov 2025-07-18