A Novel Swaddling Method To Improve Developmental Care for Preterm Babies
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Change in length of time spent in sleep
研究概览
简要总结
The investigators will test a new medical grade swaddling system for optimal and more appropriate positioning for preterm infants. This is a trial focused on sleep state, state regulation and long-term neurodevelopment. The central hypothesis is that this novel swaddling method will promote sleep and an optimal sleep-wake cycle, while also improving the neurodevelopment of preterm infants. It is proposed that adequate positioning and secondary feedback of natural movement of arms and legs stimulates and fosters normal brain development.
详细描述
Throughout pregnancy, the fetus is encouraged to develop by maintaining proper flexed posture in the uterus and freely moving its arms and legs against the flexible boundaries of the womb. However, when born too early, preterm infants lose the natural boundaries of the womb that support this flexor positioning and movement support. In addition preterm infants undergo stress because of essential treatments in neonatal intensive care units and exposure to the extrauterine environment. To support the development of preterm infants, cotton wraps are often used to maintain appropriate body positioning. Swaddling helps maintain continuous and adequate body positioning which aids and provides a stable sleep environment and encourages muscle tone. However, traditional swaddling is challenging in preterm infants and preterm infants frequently become unswaddled. It is fraught with difficulties related to the neonatal care and monitoring preterm infants receive due to the prematurity. In addition, this stiff material does not provide the same sensory experience as the flexible boundaries of the womb. In response to this challenge, The Investigators developed a new medical grade swaddling system for optimal and more appropriate positioning and natural movement. Here, The Investigators outline a trial focused on sleep state, state regulation and long-term neurodevelopment. The central hypothesis is that this novel swaddling method will promote sleep and an optimal sleep-wake cycle, while also improving the neurodevelopment of preterm infants. It is proposed that adequate positioning and secondary feedback of natural movement of arms and legs stimulates and fosters normal brain development. The Investigators will clinically evaluate sleep at the level of amplitude-integrated electroencephalograph (aEEG) activity and perform the Prechtl's Assessment of General Movements (GMA) to assess spontaneous writhing and fidgety movements, which predicts the future neurodevelopment of preterm babies. The Investigators will also perform the Neonatal Intensive Care Unit (NICU) Network Neurobehavioural Scale (NNNS) as a standardized assessment of neurological integrity and organization. The goal is to provide early intervention to improve development in preterm infants.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 24 Weeks 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born very preterm (<32 weeks postmenstrual age (PMA))
- •At least 12 hours and less than 2 months old
- •Expected to survive > 3 days
- •No congenital anomaly or genetic disorder with expected survival less than term equivalent
- •No malformations requiring surgery within 1 month of life
- •Central intravenous lines removed
- •Approval of the primary neonatologist, ideally not a study team member, to approach family for consent
- •Appropriate parent or guardian to provide informed consent
排除标准
- •Life expectancy < 3 days
- •Severe congenital anomaly or genetic disorder with life expectancy <40 weeks PMA
- •Need for seizure medication
- •Hypertension for age requiring medication
- •Severe hematologic crisis such as disseminated intravascular coagulation
- •Hydrops fetalis
- •Clinical concern or diagnosis of toxoplasmosis, cytomegalovirus rubella or syphilis infection
- •Clinical concern or diagnosis of severe acute respiratory distress syndrome coronavirus 2 (SARS CoV-2) or coronavirus disease (COVID-19)
- •Central intravenous access and reliance on parenteral nutrition >50%
- •Respiratory support greater than nasal canulae or nasal continuous positive airway pressure (CPAP) (i.e. ventilator dependent)
- •Active infection, including need for antibiotics greater than 5 days (i.e. confirmed infection)
- •Complex congenital heart disease
- •Known chromosomal abnormalities
- •Clinical or echocardiographic signs of symptomatic pulmonary hypertension
- •Profound perinatal hypoxia-ischemia
- •Receiving treatment for pain control
- •Sustained tachypnea >80 breaths/minute
- •Need for volume expansion or administration of inotropes
- •No one available or willing to provide consent
研究组 & 干预措施
Conventional Swaddle
The management of the non-intervention group is with a cotton swaddle that is standard of care. It represents a conventional standard management method using a swaddle made of cotton.
Novel Swaddle
The Novel Swaddle is made of fabric consisting of 85% nylon and 15% polyurethane. This fabric provides heat retention, is hygroscopic and stretches in both longitudinal and transverse directions, thus more accurately replicating the intrauterine environment. The novel material is sewed into a bag shape.
干预措施: Novel Swaddle (Other)
结局指标
主要结局
Change in length of time spent in sleep
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG, the Investigators will assess the change in length of time (in minutes) spent in sleep.
Change in Sleep-Wake Cycling Maturity as assessed by amplitude integrated EEG (aEEG) readings
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG, the Investigators will assess the presence or absence of mature sleep-wake cycling as defined as regular rhythmic sinusoidal variations of amplitude with a cycle greater than or equal to 20 minutes. Tracings with a cycling pattern that does not fit into a mature sleep-wake cycle for the majority of the tracing will be classified as intermediate.
Change in the number of awakenings in a 3 hour time period
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG, the Investigators will assess the change in number of awakenings in a 3 hour time period.
Change in voltage as assessed by aEEG) readings
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG, the Investigators will assess the change in voltage (measured in microvolts).
Change in ratio of active sleep and quiet sleep as assessed by amplitude integrated EEG (aEEG) readings
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG The Investigators will assess the time spent in active sleep (irregular and low in amplitude) and quiet sleep (regular and high in amplitude).
Change in Sleep-Wake Cycling Continuity as assessed by amplitude integrated EEG (aEEG) readings
时间窗: 32 weeks postmenstrual age, 34 weeks postmenstrual age and 36 weeks postmenstrual age
Using aEEG The Investigators will examine the background activity on recordings to assess the presence or absence of isoelectric periods along with amplitude fluctuations. Tracings will be classified as continuous, discontinuous and borderline.
次要结局
- Behavioral Maturity as assessed by the NNNS(37 weeks postmenstrual age)
- Change in General Movements as assessed by the GMA(32 weeks postmenstrual age and 37 weeks postmenstrual age)