Environmental Enrichment Intervention and Brain Development in Preterm Infants

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard Developmental Care: Standard developmental care and routine medical follow-up provided within usual clinical practice. This care reflects established developmental support approaches typically offered to preterm infants and does not include structured environmental enrichment or the Homeostasis-Enrichment-Plasticity (HEP)-based intervention applied in the experimental group.

Environmental Enrichment-Based Intervention: Environmental enrichment-based program applied for 12 weeks, including sensory-motor stimulation, environmental novelty, problem-solving tasks, and active exploration with caregivers.

Study summary

This study aims to evaluate the effects of a structured environmental enrichment (EE)-based early developmental intervention on brain, motor, and cognitive outcomes in preterm infants. Infants born before 37 weeks of gestation are at increased risk for alterations in structural and functional brain development, which may be further influenced by the neonatal intensive care environment, including exposure to excessive light, noise, and frequent medical procedures.

The intervention is a prospectively implemented, home-based developmental program structured according to the HEP (Homeostasis-Enrichment-Plasticity) approach, providing enriched sensory-motor experiences, environmental novelty, problem-solving activities, and opportunities for active exploration. The program is delivered through guided parental involvement with support from trained therapists, according to a predefined protocol.

Developmental outcomes will be assessed at baseline and after the intervention period using standardized, non-invasive assessment tools. The intervention does not include any pharmacological treatment or medical device. This study evaluates whether participation in an EE-based early developmental intervention leads to improved neurodevelopmental outcomes in preterm infants.

Eligibility

Primary outcome measure(s)

• Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III) — Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
  Motor development will be assessed using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), Motor Composite Score, which evaluates fine and gross motor development. The Motor Composite Score ranges from 40 to 160, with higher scores indicating better motor development.
• Motor Performance Assessed by Test of Infant Motor Performance (TIMP) — Baseline (corrected age of 1 month) and 12 weeks (end of intervention)
  Motor performance will be assessed using the Test of Infant Motor Performance (TIMP), which evaluates postural and selective control of movement in young infants. The TIMP total score ranges from -49 to 142, with higher scores indicating better motor performance.

Trial sites (1)

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