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临床试验/NCT03370757
NCT03370757已完成不适用

Very Low Birthweight (VLBW) Preterm Infant Skin Health With Bundled Care in the Neonatal Intensive Care Unit (NICU): A Randomized Controlled Trial

Duke University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2018年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
Mean Heart Rate by Group

研究概览

简要总结

The purpose of this study is to explore the impact of bundling nursing care activities on the overall health of Very Low Birthweight (VLBW) preterm infants who receive bundled care in a Level IV Neonatal Intensive Care Unit (NICU). The study will evaluate differences in infant health when diaper changes occur at 3- versus 6-hours during 3-hour bundled care. Differences in infant skin health between 3- and 6-hour bundled care diapering at two sites (buttocks and chest) will also be evaluated.

详细描述

Preterm infants' growth and developmental outcomes vary with illness severity and degree of neurological insult and unpredictable variations in outcomes exist even among healthy preterm infants. The variations in preterm infants' outcomes have led to the supposition that the neonatal intensive care unit (NICU) environment may negatively impact the health and development of these infants and significant research has been devoted to examination of light, noise, and caregiving interventions. Consequently, many NICUs have implemented neuroprotective strategies to reduce over simulation, promote sleep and facilitate brain development in high-risk infants including the grouping of care activities around a single caregiving event described as "clustering" or "bundling care". Yet, the number and type of caregiving activities that are included in bundled care and the timeframe between bundled care events has not been systematically studied. The inclusion and exclusion of certain care activities in any individual care event is often dictated by the infant's treatment plan or needs, but some activities like diapering may be optional. Understanding the impact of when to include optional, yet stress provoking interventions, will allow us to minimize overall environmental stress in hospitalized very low birthweight (VLBW) infants. Therefore, given the lack of data around bundled care, the investigators aim to explore through a randomized controlled design the impact of bundling diaper care activities on overall health of VLBW preterm infants. The investigators will include a focus on skin health because it is important to understand the benefits of decreased infant stress and any potential skin health trade-offs associated with longer versus shorter time between diapering care. Findings from this study will allow us to better understand the relationship between neonatal skin health while providing developmentally appropriate bundled care.

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
None

入排标准

年龄范围
— 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Must be participating in the Intensive Care Nursery standard 3-hour bundled care
  • Must wear a breathable diaper
  • Must be ≤ 32 weeks gestation at birth and weigh ≤ 1500g at birth.
  • Infants are expected to remain hospitalized for at least 4 weeks

排除标准

  • Neonatal Abstinence Syndrome
  • Humidified incubator
  • Diaper rash
  • Pre-existing or genetic skin conditions
  • Use of barrier creams
  • Severe illness requiring 1:1 nursing care: e.g. minimal stimulation protocol, high frequency ventilation, vasopressor drug support, or body cooling.

结局指标

主要结局

Mean Heart Rate by Group

时间窗: During hospitalization, approximately four weeks

Heart rate instability was defined as having a mean heart rate value during a bundled care event that was ≥1 standard deviation above or below the mean heart rate value during the 90 minutes before the event started. In addition, clinically meaningful parameters were added to indicate exceptions to this definition. For HR, mean values ≥ one standard deviation below the mean was categorized as physiologically unstable only if the mean value was \< 100. Based on these criteria, each observation was categorized as physiologically unstable or not.

次要结局

  • Microbiota Diversity of the Skin at Both the Buttocks and Chest Sites and Stool by Group(During hospitalization, approximately four weeks)
  • Estimates of Infant Buttock Transepidermal Water Loss (TEWL) by Group(During hospitalization, approximately four weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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