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Environmental Enrichment Intervention and Brain Development in Preterm Infants

Study acronym: PRE-ENV
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated June 16, 2026 (before its estimated August 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status changed: Not Yet Recruiting → Active, Not Recruiting
    • Primary completion pushed from Jun 30, 2026 to Aug 30, 2026
    • Study completion pushed from Jul 30, 2026 to Sep 30, 2026
    • Site contact updated
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07343505
Lead Sponsor Eskisehir Osmangazi University
Conditions
(from sponsor)		 Preterm Birth
Related terms Premature Birth
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov