Early Intervention in Preterm Infants: Effects of a Parental Training Program on Neonatal Brain Development, Visual Functions and Neurobehavioral Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Neonatal Visual Assessment Battery to evaluate visual function
研究概览
简要总结
Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period of stressful environment, which may negatively impact early brain development and subsequent neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in reducing stressful experiences early in life and in enhancing brain development and long term developmental outcomes.
详细描述
Very preterm birth is associated with motor, cognitive and behavioral problems.
Micro-structural brain abnormalities, even in the absence of focal lesions, have been documented by neuroimaging studies in preterm infants at term corrected age and later in childhood. These alterations in brain maturation occurring during the neonatal period may be implicated in long-term neurobehavioral disorders later experienced by preterm babies.
However, there is increasing evidence that also negative environmental factors (intensive care, excessive sensory stimulation, paucity of parental contact etc.) can affect later outcomes.
Potential benefits of early dyadic interaction and preterm baby massage in reducing the effects of the NICU stressor environment have been demonstrated. More recently, few studies have investigated visual function in preterm infants focusing on the potential role of early visual interaction to enhance attention and improve later neurodevelopment.
The role of early intervention strategies to improve neurodevelopment has been recently emphasized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 25+0 and 29+6 weeks
排除标准
- •major brain lesions as documented by cranial ultrasound (intraventricular hemorrhage > 2 grade, cystic periventricular leukomalacia)
- •neurosensorial deficits (retinopathy of prematurity > stage 2)
- •genetic syndromes and/or major congenital malformations
- •major neonatal comorbidities
- •Mothers are selected according to the following inclusion criteria: age over 18 years, good comprehension of Italian language, no obvious cognitive impairments or psychiatric disorders, no drug addiction and no single-parent families.
结局指标
主要结局
Neonatal Visual Assessment Battery to evaluate visual function
时间窗: 40 weeks postmenstrual age
Neonatal Visual Function is assessed using the Visual Assessment Battery developed by Ricci et al. The assessment evaluates the following items: Ocular spontaneous motility, ability to fix and follow a target, reaction to colour, visual acuity and visual attention at distance. Each item is scored as normal (score 0) or abnormal (score 1). The global score is then calculated as the sum of all the individual items, as designed by the authors.
Neonatal Behavior
时间窗: 2 months corrected age
Neonatal behavior is assessed using the Neonatal Behavior Assessment Scale that evaluates: habituation, social-interactive, motor system, state organization and regulation, autonomic system, reflexes.
次要结局
- Epigenetic changes(up to 48 weeks gestational age)
- overall duration of hospitalisation(up to 48 weeks gestational age)
- Head circumference (in centimeters) at 40 weeks postmenstrual age(40 week gestational age)
- Developmental outcome(24 months corrected age)
- Feeding with Human milk(up to 40 weeks gestational age)
- Brain development(40 weeks postmenstrual age)
- Acquisition of full oral feeding(up to 48 weeks gestational age)
- Neurodevelopmental outcome(5-6 years of age)
- Weight (in grams) at 40 weeks postmenstrual age(40 week gestational age)
- Length(in centimeters) at 40 weeks postmenstrual age(40 week gestational age)
- Behavioral outcome(5-6 years of age)
- Attention outcome(5-6 years of age)
- Neuromotor outcome(5-6 years of age)
- L1 promoter methylation levels on buccal swab(5-6 years of age)