Early Visual Stimulation in Preterm Infants at Home From 0 to 3 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual function - alertness, fixation, attention, tracking
研究概览
简要总结
Introduction: Prematurity rate has increased and is a risk factor for developmental delay. Preterm infants with low visual tracking might present deficits in cognition, language, and fine motor function in future ages. Few studies applied home stimulation of the visual system for preterm infant (PT) at an early age.
Objective: To compare the effects of early visual stimulation to a standard care group in visual function, motor and sensory development.
Methods: Randomized controlled trial. At home setting. Thirty healthy preterm infants, gestational age from 28 to 37 weeks, aged from one to two months of corrected age at the entrance of the study, with low visual function, will be evaluated. Participants will be randomly allocated to: (1) a standard care group, receiving orientation about general sensory and motor development, (2) an early visual stimulation group receiving a 4-week home based protocol applied by caregivers additional to standard care. Outcomes will be measured at before the beginning of stimulation, at the end of stimulation and at 6 months of corrected age. Primary outcome is visual function evaluated by ML Leonhardt Battery of Optotypes. Secondary outcomes include motor and sensory development evaluated by scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Two kind of researchers will be part of the study: a) assessors, which are the researchers that will perform assessments and apply stimulation with the caregivers; b) ratters, which are the researchers that will rate the scales from videos. Assessors will not be blind to group allocation. Ratters will be masked to group allocation, since videos analyses will be performed using coded study allocation. The statistician will also be blind to group allocation.
入排标准
- 年龄范围
- 1 Month 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •gestational age between 28 and 37 weeks
- •age at enrolment between one to two months of corrected age t
- •absence of visual impairments evaluated with Red Reflex Examination and complete ophthalmology exam, which will be performed by a doctor at the hospital or the basic health units where the infants will be recruited
- •infants at home
- •presence of low acuity assessed by the ML-Leonhardt Optotypes Battery (absence of alertness, fixation and attention in at least three cards, or visual tracking classified as absent or brief for more than three cards)
排除标准
- •presence of any diagnosed neurological diseases
- •presence of diagnosed respiratory diseases
- •hypoxemia, hyperventilation or hypo-ventilation during assessments
- •presence of congenital diseases
- •presence of diagnosed visual impairments, such as blindness or low vision
- •extreme premature, ie, with gestation age bellow 28 weeks due to higher risk of retinopathy of prematurity
- •birth weight less than 1,000 grams due to higher risk of retinopathy of prematurity
- •absence of alertness according with Precthl and Beintema
- •preterm infant with unstable physiological conditions
- •preterm infant receiving any kind of intervention such as physical therapy, occupational therapy, early intervention, aquatic stimulation, at the same time that our stimulation protocol is being applied since they can be confounders
- •infants with medical fragility that prevent them to participate.
结局指标
主要结局
Visual function - alertness, fixation, attention, tracking
时间窗: change measure: first day - before intervention; after intervention at home (28 days)
Visual acuity will be assessed with ML Leonhardt Battery of Optotypes (MLLBOS) scale. MLLBOS consists of 8 visual carts, with high-contrast visual images of 12X12cm. The scale evaluates alertness, attention, fixation and visual tracking. The evaluation will be recorded by a digital video camera. The camera will be positioned fixed to the infant's face.
次要结局
- Motor Development(change measure: at 6 months of corrected age)
- Sensory profile(change measure: first day - before intervention; after intervention at home (28 days); at 6 months of corrected age)
研究者
Adriana Neves Dos Santos
Professor, Reseacher
Universidade Federal de Santa Catarina