NEOVIDEO : Impact of Monitoring Motor Activity by Video Analysis on the Sleep of Very Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 4
- 主要终点
- Quantification of the percentage of time spent in sleep
研究概览
简要总结
Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity.
The collection system provide neonatal care nurse with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions).
This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.
详细描述
According to the EuroPeristat 2014 report, 1% of births are very preterm infants. Very premature birth and the necessary hospitalization expose to a risk of morbidity and mortality which impacts the neurodevelopmental prognosis. Sleep and behavior monitoring have not been developed in the neonatal units. This has to be improved since it is known from clinical and animal studies that the quality, organization and quantity of sleep in very preterm infants impact neurological development and brain plasticity. The publications suggest that alterations in sleep could have a significant impact on acquisitions in the areas of learning, memory, sensory development and behavior, as well as in the area of cardiorespiratory regulation. It has been shown that the implementation of developmental care practices (taking into account lighting, noise, the position of newborns and their rhythms) could have short-term beneficial effects on the sleep of very preterm infants. However, studies remain very limited in number. The investigators propose to build on the infrastructure developed as part of the H2020 DigiNewB project (http://www.digi-newb.eu/), which can provide neonatal care providers with access to motion curves (evaluated by signal processing of live video) and real-time infrared video (also available in low-light conditions).The collection system is functional, allows continuous analysis of videos to quantify movement and is suitable for incubators and neonatal beds. This new non-invasive technology allows an evaluation of the activity cycles of the newborn by the caregivers which until now was only accessible occasionally by short recordings of actigraphy or polysomnography. The investigators wish to demonstrate that this can contribute to an organization of care that respects the sleep patterns of the newborn, which they know to condition the neurodevelopmental prognosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hospitalized in neonatology,
- •at least one of whose legal representatives has given free, informed and written consent,
- •term of birth <32 WA, postnatal age> 15 days and post-conceptual age between [30-38] WA,
- •affiliated to a social security scheme
- •Caregivers:
- •having at least 1 year of practical experience in neonatology,
- •having been trained in the clinical basics of evaluating newborn sleep,
- •having given their consent to participate.
排除标准
- •sedative or curare treatment (opiates, benzodiazepines, curare, barbiturates) in the last 24 hours,
- •chromosomal abnormalities identified
- •Planned discharge date incompatible with the completion of the entire study
- •No criteria for caregivers
结局指标
主要结局
Quantification of the percentage of time spent in sleep
时间窗: for 8 days
Quantification of the percentage of time spent in sleep (stage 1 + 2 of the neurobehavioral classification of Prechtl in 5 stages compared to the total duration of the analyzable tracing) by a supervised expert, viewing the blinded sequences of the condition tested (with and without access caregivers to video and movement curves).
次要结局
- Quantification of the ratio of time spent in calm sleep / time spent in restless sleep .(for 8 days)
- - Quantification of the percentage of time spent in the 5 stages of Prechtl / total analyzable tracing time.(for 8 days)
- - Quantification of sleep fragmentation and the different types of transitions: number and duration of awakening periods(for 8 days)
- - Quantification of sleep fragmentation and the different types of transitions: number and duration of movement periods (periods defined by successions of movements spaced less than 5 seconds apart)(for 8 days)
- - Quantification of sleep fragmentation and the different types of transitions: classification of all transitions between stages(for 8 days)
- - Textual analysis (lexical field) of the interview with the nursery nurses on their feelings about the device(At the end of 8 days recordings)
- - Analysis of the score of the "Ages and Stages questionnaires / Second Edition" sent to parents before their child's 24-month visit.(at 24 months)
- - Care interventions: Quantification of the number and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)(for 8 days)
- - Care interventions: Quantification of the type (noise or manual intervention) and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)(for 8 days)
- - Care interventions: Quantification of the duration and estimated stage of sleep at their initiation (in the 2 minutes preceding the intervention)(for 8 days)
- - Textual analysis (lexical field) of the interview with the parents on their feelings about the device(At the end of 8 days recordings)