A Prospective Study Investigating the Effects of an Environmental Enrichment-Based Intervention on Brain Development in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
研究概览
简要总结
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.
详细描述
The purpose of this study is to investigate the effects of an environmental enrichment (EE)-based early developmental intervention on brain, motor, and cognitive development in preterm infants. Infants born before 37 weeks of gestation are at increased risk for alterations in brain structure and subsequent neurodevelopmental challenges. In addition to biological vulnerability, early sensory experiences and environmental factors may influence developmental trajectories during infancy.
This study will examine developmental outcomes together with brain morphometric measurements and urinary biochemical markers, including brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), Tau, and S100B.
Objectives:
- To assess urinary biochemical markers, brain morphometry, and motor and cognitive development in preterm infants at corrected 1 month of age.
- To examine relationships among urinary biochemical markers, brain morphometry, and developmental outcomes at baseline.
- To compare changes in biochemical, neuroimaging, and developmental outcomes over a 12-week period between infants receiving standard care and those receiving an EE-based intervention.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HEP Home-Practice Group:
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.
干预措施: Environmental Enrichment-Based Intervention (Behavioral)
Control Group
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.
干预措施: Standard Developmental Care (Other)
结局指标
主要结局
Motor Development Assessed by Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III)
时间窗: 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)
时间窗: 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.
次要结局
- 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))
- Urinary Concentration of S100 Calcium-Binding Protein B (S100B)(Baseline (corrected age of 1 month) and 12 weeks (end of intervention))
- Depression, Anxiety, and Stress Scale-21 Items (DASS-21) Total and Subscale Scores in Caregivers(Baseline and 12 weeks (post-intervention))
研究者
Tuğçe Altıok
PhD Candidate
Eskisehir Osmangazi University