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.
Eligibility
Sex
ALL
Min age
6 Years
Max age
9 Years
Healthy volunteers
Accepted
Inclusion Criteria:
For Preterm-Born (PTB) Children:
* Born preterm (i.e., gestational age \< 39 weeks)
* Aged between 6 and 9 years at enrollment
* Absence of structural brain lesions (as assessed by prior clinical imaging)
* Italian as the first language (L1)
* Right-hand dominant
* Male or female
For At-Term-Born (ATB) Children:
* Born at term (i.e., gestational age between 39 and 42 weeks)
* Aged between 6 and 9 years at enrollment
* Absence of structural brain lesions (as assessed by prior clinical imaging)
* Italian as the first language (L1)
* Right-hand dominant
* Male or female
Exclusion Criteria:
For Preterm-Born (PTB) Children:
* History of congenital infections
* Diagnosis of Multiple Congenital Anomalies Syndrome
* Presence of focal intracerebral parenchymal lesions
* Pathological findings on conventional MRI
For At-Term-Born (ATB) Children:
* Presence of first-degree relatives diagnosed with developmental dyslexia (DD)
* Diagnosis of other learning or behavioral disorders
* Contraindications to MRI (e.g., metal implants, severe claustrophobia)
Primary outcome measure(s)
Change in RFST Auditory Modality Composite Score From Grade 2 to Grade 3 in Preterm Children — From Grade 2 baseline to Grade 3 follow-up assessment (approx. 8-10 months) Composite score summarizing auditory-based sensorimotor, timing, discrimination, and inhibitory control abilities measured via the ReadFree Screening Tool (RFST) auditory modality tasks. Includes:
* Auditory Reaction Time (median RTs of 8 trials)
* Tapping and Entrainment to Metronome (tapping onset)
* Free Tapping (motor rhythm without auditory cue)
* Tone Discrimination (smallest perceptible pitch interval)
* Cocktail Party Task (d-prime, target detection in multitalker noise)
* Auditory Go/No-Go (d-prime, inhibition)
* Auditory Anticipatory Timing (tapping onset accuracy) Each task is z-scored and aggregated into a single composite. Higher scores indicate better auditory sensorimotor and temporal processing.
Change in RFST Visual Modality Composite Score From Grade 2 to Grade 3 in Preterm Children — From Grade 2 baseline to Grade 3 follow-up assessment (approx. 8-10 months) Composite score summarizing visual-based sensorimotor, discrimination, and inhibitory control abilities from the RFST visual modality tasks. Includes:
* Visual Reaction Time (median RTs of 8 trials)
* Tapping and Entrainment to Visual Cue (tapping onset)
* Free Tapping (motor rhythm without visual cue)
* Grey-Scale Discrimination (smallest perceptible luminance interval)
* Visual Go/No-Go (d-prime, visual inhibition)
* Visual Anticipatory Timing (accuracy of tapping onset)
* RAN-Shapes (number of shapes named in 30s) Each score is converted to z-units and averaged to yield a composite metric. Higher scores indicate better visual-motor and perceptual timing performance.
Grade 2 Composite Language Score in Preterm Children — Grade 2 baseline assessment A standardized composite language score derived from z-transformed or scalar scores of the following assessments:
* Phoneme Deletion
* BVL Auditory Discrimination (HIT-False Alarm Index, range: -100% to +100%)
* NEPSY-II Subtests: L1, L3, L4, L5. The composite reflects mean z-scores (normalized against internal sample distribution) across all measures. Higher scores indicate better language functioning.
Grade 2 Composite Attention Score in Preterm Children — Grade 2 baseline assessment A composite attention score computed from standardized or scalar scores across the following assessments:
* Colored Raven Matrices (Percentiles by age: 3rd-95th)
* NEPSY-II Subtests:
* A1 Visual Search
* A2 Figural Fluency
* A3 Auditory Attention
* A4 Inhibition (Time; Accuracy)
* A6 Categorization Each test is converted to a z-score and averaged for a domain-wide summary score. Higher scores indicate better attention performance.
Grade 2 Composite Reading Score in Preterm Children — Grade 2 baseline assessment Composite score combining metrics from multiple timed and accuracy-based reading assessments:
* Lapel Reading Song (Words per minute: 21-157; Errors: 0-10)
* PIN Reading (Words and Pseudo-words):
* Reading Time
* Syllables/sec
* Number of Errors Each metric is z-normalized and averaged per task, then aggregated for a domain-level composite. Higher composite scores indicate better learning performance.
Grade 2 Resting-State fMRI Network Segregation Score in Preterm Children — Grade 2 baseline MRI session Resting-state functional connectivity-based modularity score, measuring the extent to which functional networks in the brain are subdivided into non-overlapping, highly interconnected communities. Higher modularity indicates greater network segregation.
Grade 2 Resting-State fMRI Network Integration Score in Preterm Children — Grade 2 baseline MRI session Participation coefficient derived from resting-state fMRI data, quantifying the extent to which brain nodes form diverse intermodular connections. Higher participation coefficient reflects greater network integration and communication between functional modules.
Trial sites (1)
Facility
City
Region
Status
Neuroradiology Unit and CERMAC, IRCCS Ospedale San Raffaele
Milan
MI
More Università Vita-Salute San Raffaele trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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