Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Bayley Scales of Infant Toddler Development, 4th Edition
研究概览
简要总结
The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.
详细描述
Two-hundred fifteen parent-infant dyads of preterm infants born ≤ 32 weeks gestation and admitted to a Level IV NICU (and associated Level III NICU) will be enrolled within 1 week of birth. Infants will be randomized to either the SENSE multisensory program or to the standard of care during the NICU stay. The SENSE program combines structured, easy-to-conduct, multisensory interventions with parent engagement to optimize outcomes in the complex medical environment of the NICU. Standardized assessments of parent mental health, infant neurodevelopment, and parent-child interaction will be conducted prior to NICU discharge and at 6 months, 1 year, and 2 years, adjusted for prematurity. Differences between groups will be investigated. Brain activity during NICU stay, including in the presence and absence of different sensory exposures, will also be investigated. The expected outcome is that the SENSE multisensory program will have a positive effect on improving outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Parents will enroll in this study, understanding that they will be assigned to one of two types of sensory approaches. They will be masked from whether they are in the treatment (SENSE group) or control group (standard of care). After enrollment, the SENSE program will be described to those parents assigned to the SENSE group. The use of nurses and therapists to aid the parent in conducting sensory interventions at the bedside will be described to those parents assigned to the standard of care group. All assessments in the NICU will be conducted at the infant's bedside by a certified (when necessary) and trained evaluator who is blinded to treatment assignment. All assessments following NICU discharge will be conducted by a different blinded evaluator (to decrease bias), who is trained and experienced with standardized childhood assessment. The evaluators will not be involved in other study-related activities in order to maintain blinding.
入排标准
- 年龄范围
- 1 Day 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≤ 32 weeks estimated gestational age (EGA)
- •recruited within the first week of life
排除标准
- •> 32 weeks EGA at birth
- •>7 days old
- •become wards of the state
- •have a suspected or confirmed congenital anomaly
- •face a high immediate threat of death, per the opinion of the attending physician.
研究组 & 干预措施
Monitored standard of care
At the study site, much like other contemporary NICUs, parents are encouraged to be present 24 hours per day, with significant variability in the amount, types and timing of parent engagement. Infant holding is supported, provided the infant can maintain physiological stability during handling. Parents can hold infants on mechanical ventilation, but holding is not encouraged during times when the infant is on oscillatory ventilation and/or when chest tubes are in place. Holding time may be restricted in infants <32 weeks due to temperature instability. Nurses and therapists foster parent participation through instruction on caregiving and developmentally appropriate interactions, but these are balanced with other priorities of care. With standard of care, there is no targeted and set amount of positive sensory exposure, and practices vary based on the comfort level of nurses, the medical team, and the parents.
干预措施: Monitored standard of care (Behavioral)
SENSE multisensory program
The SENSE program includes the provision of specific types and amounts of evidence-based tactile, auditory, visual, vestibular/kinesthetic, and olfactory interventions to be conducted by parents with their preterm infants, with a specific amount defined for each day of hospitalization. The program changes across PMA and an infant's tolerance of the prescribed activities. A sensory support team can fill in the gaps in intervention for infants in the SENSE group when parents are not available. The parent education materials identify specific doses of sensory inputs at each PMA. Feasibility has been established, with provision of an average of 155 hours of sensory exposures across NICU hospitalization.
干预措施: SENSE multisensory program (Behavioral)
结局指标
主要结局
Bayley Scales of Infant Toddler Development, 4th Edition
时间窗: 2 years adjusted age
Standardized assessment of language, cognitive, and motor: language outcome is the primary outcome
次要结局
- Sensory Profile 2(Prior to NICU discharge and at 6 months, 1 and 2 years adjusted age,)
- State Trait Anxiety Inventory(Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age)
- Bayley Scales of Infant Toddler Development, 4th Edition(6 months and 1 year adjusted age (when completed in newborn follow-up clinic))
- Modified Checklist for Autism in Toddlers(2 years adjusted age)
- NICU Network Neurobehavioral Assessment Scale(Between 35-41 weeks PMA)
- aEEG Burdjalov Score(within two weeks of birth, at 30 and 34 weeks PMA, and between 35-41 weeks PMA for six continuous hours)
- Life Stress Subscale of the Parenting Stress Index (PSI)(Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 6 months, one and 2 years adjusted age)
- Ages and Stages Questionnaire-3(6 months adjusted age, 1 and 2 years adjusted age)
- Child Behavior Checklist (CBCL)(2 years adjusted)
- Edinburgh Postnatal Depression Scale (EPDS)(Prior to the infant's discharge from the NICU (35-41 weeks PMA))
- Emotional Availability Scales(Prior to the infant's discharge from the NICU (35-41 weeks PMA) and at 2 years adjusted)
研究者
Roberta Pineda
Assistant Professor
University of Southern California