Environmental Enrichment Intervention and Brain Development in Preterm Infants

NCT07343505 | Not Yet Recruiting

• 2 other identifiers: ESOGU-TA-PretermEE-001TDK-2025-3575
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Preterm infants; Environmental enrichment; Home-based intervention; Early intervention; Brain development; Cognitive development; Motor development; Neurodevelopment

Outcome Measures

Primary Outcomes (2)

• Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)

  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.

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

• Motor Performance Assessed by Test of Infant Motor Performance (TIMP)

  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.

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

Secondary Outcomes (7)

• Cognitive 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)

• Brain Morphometric Measurements Assessed by Cranial Ultrasound Imaging

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

• Urinary Concentration of Brain-Derived Neurotrophic Factor (BDNF)

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

• Urinary Concentration of Nerve Growth Factor (NGF)

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

• Urinary Concentration of Tau Protein

  Baseline (corrected age of 1 month) and 12 weeks (end of intervention)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Infants in this group will receive conventional developmental therapy and routine medical follow-up as provided within standard clinical practice. This approach represents an active comparator and does not include the structured environmental enrichment or the Homeostasis-Enrichment-Plasticity (HEP)-based intervention used in the experimental group. Participants in this group will undergo the same study-related assessments as the intervention group at baseline and after 12 weeks.

Other: Standard Developmental Care

HEP Home-Practice Group:

EXPERIMENTAL

A structured environmental enrichment-based developmental intervention delivered over a 12-week period. The program is based on the Homeostasis-Enrichment-Plasticity (HEP) framework and includes age-appropriate sensory-motor activities, environmental novelty, problem-solving opportunities, and active caregiver-infant interaction. The intervention is delivered through weekly therapist-guided sessions, with caregivers encouraged to continue the practices at home as part of daily care.

Behavioral: Environmental Enrichment-Based Intervention

Interventions

Environmental Enrichment-Based Intervention BEHAVIORAL

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

HEP Home-Practice Group:

Standard Developmental Care OTHER

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.

Control Group

Eligibility Criteria

• Age: 4 Weeks - 7 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born before 37 completed weeks of gestation.
• Corrected age between 4 and 7 weeks at the time of enrollment.
• Medically stable, as confirmed by the attending neonatologist
• Written informed consent obtained from parents or legal guardians.

You may not qualify if:

• Major congenital anomalies or known genetic syndromes.
• Severe intraventricular hemorrhage (Grade III-IV) or other major neurological impairment.
• Unstable medical conditions that would interfere with safe participation in the study procedures.
• Caregivers unable to attend scheduled study sessions or comply with study-related procedures.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Tuğçe Altıok Physical Therapy Center

Nilufer, Bursa, 16110, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Tuğçe Altıok, PhD

  Eskisehir Osmangazi University, Institute of Health Sciences

  STUDY DIRECTOR

• Ferruh Yücel, Professor, PhD

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

• Aymen Balıkçı, PT, PhD

  Aymen Balıkçı Physical Therapy Clinic

  STUDY DIRECTOR

• Teresa A. May-Benson, PhD

  Teresa A. May-Benson Therapy Clinic

  STUDY DIRECTOR

Central Study Contacts

Tuğçe Altıok, PhD / PT

CONTACT

+90 555 101 74 93; 522620221000@ogrenci.ogu.edu.tr

Ferruh Yücel, Professor, PhD

CONTACT

+90 533 626 64 58; yferruh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Model Details: Participants will be prospectively assigned to one of two parallel groups using stratified assignment based on gestational age. One group will receive standard care alone, while the other group will receive a structured environmental enrichment-based HEP home intervention in addition to standard care.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: January 15, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)