Pilot Study of Nurse-Administered Touch and Biobehavioral Stress Responses of Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Average Heart Rate -- During Intervention
研究概览
简要总结
Randomized cross-over clinical trial to determine the effect of a nurse-administered comforting touch intervention on the biobehavioral stress responses of preterm infants hospitalized in the neonatal intensive care unit.
详细描述
Preterm infants will receive one episode of essential nursing care as standard care and one episode of essential nursing care that includes a nurse-administered comforting touch intervention approximately 24 hours apart in a randomized sequence. For 10 minutes prior to the start of the two observed care episodes, during the care episodes, and for 60 minutes after the conclusion of the care episodes, researchers will measure infants' biobehavioral stress responses. When infants reach 35 weeks post-menstrual age, researchers will perform a neurobehavioral assessment.
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
- None
盲法说明
The statistician performing the data analysis will be blinded to group.
入排标准
- 年龄范围
- — 至 10 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born prematurely between 27 and 30 weeks post-menstrual age.
- •Born to mothers who are English-speaking and able to provide informed consent.
- •No more than 10 days old at the time of enrollment.
排除标准
- •Diagnosed with Grade III/IV intraventricular hemorrhage or other neurologic abnormality (e.g. seizure disorder) affecting sensory perception or motor function.
- •Diagnosed with a congenital anomaly requiring surgery during the neonatal period.
- •Receiving scheduled steroids or vasopressors.
- •Skin conditions that preclude the attachment of sensors.
- •Diagnosed with Neonatal Abstinence Syndrome or born to mothers with known illicit drug use, except marijuana, during pregnancy.
- •Diagnosed with chromosomal abnormalities.
- •Requiring special isolation with universal gloving for potentially infectious pathogens.
结局指标
主要结局
Average Heart Rate -- During Intervention
时间窗: during intervention or control period, approximately 20 minutes
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
Average Heart Rate -- Recovery
时间窗: recovery, 30 minutes after intervention delivery or control period
heart rate in beats per minute will be measured using an external electrocardiogram monitor and averaged over the intervention or control period
次要结局
- Average High-frequency Heart Rate Variability -- During Caregiving Episode(during caregiving episode that included either the nurse-administered touch intervention or was delivered as standard care, approximately 20 minutes)
- Average High-frequency Heart Rate Variability -- Recovery(recovery, 30 minutes after caregiving that included either the nurse-administered touch intervention or standard care)
- Average Frequency of Skin Conductance Responses -- During Caregiving Episode(during caregiving episode, approximately 20 minutes)
- Average Frequency of Skin Conductance Responses -- Recovery(recovery, 30 minutes after intervention delivery or control period)
研究者
Marliese Nist
Assistant Professor
Ohio State University