Environmental Enrichment Intervention and Brain Development in Preterm Infants

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.

Conditions

• Preterm Birth

Interventions

OTHER

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• Eskisehir Osmangazi University

  lead OTHER

Principal Investigators

• Tuğçe Altıok, PhD · Eskisehir Osmangazi University, Institute of Health Sciences

• Ferruh Yücel, Professor, PhD · Eskisehir Osmangazi University

• Aymen Balıkçı, PT, PhD · Aymen Balıkçı Physical Therapy Clinic

• Teresa A. May-Benson, PhD · Teresa A. May-Benson Therapy Clinic

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Weeks

Max Age

7 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-15

Primary Completion

2026-06-30

Completion

2026-07-30

Countries

• Turkey (Türkiye)

Study Locations