Kangaroo Care to Blunt Pain in Premature Infants

描述(申请人提供)：24名30-32周胎龄和出生后2-9天的早产儿将被招募进行交叉设计研究，以测试袋鼠护理(KC)，母亲将尿布裹在婴儿身上的皮肤对婴儿的影响，以及对脚后跟粘连的钝化生理、激素和行为反应的影响。脚后跟贴是住院早产儿最常见的反复疼痛程序。疼痛经历，无论是急性还是慢性，都与神经和免疫功能受损有关。袋鼠护理可能是一种额外的疼痛管理干预措施，如果它对钝性心率(HR)、血浆和唾液皮质醇、早产儿疼痛状况(PIPP)评分和哭泣时间以及因脚后跟疼痛而增加心率变异性(HRV)有影响。数据将在两天内收集，所有鞋跟在上午11点开始收集。作为日常实验室常规抽血的一部分。婴儿被随机分配到A组(第一天KC，常规孵化器护理第二天)或B组(常规孵化器第一天KC，第二天KC)。婴儿将在10：00至11：30躺在保育箱中进行常规保育器护理，脚后跟在保育箱中；在KC日，婴儿将于上午10：00至11：30在KC。把鞋跟贴在KC做好。两组患者在上午10：45开始HR和HRV记录、哭声持续时间的声控记录、PIPP的录像和行为状态测量(一个中间变量)。上午11：00获得唾液皮质醇样本和血浆皮质醇样本。第二份唾液皮质醇样本将在鞋跟后21分钟采集。在第二次唾液皮质醇采样结束时，停止心率、心率变异性、哭泣持续时间和行为状态测量。PIPP针对脚跟棒序列的每个阶段进行评分。唾液皮质醇与血清水平有很好的相关性，并将提供鞋跟后20-21分钟内激素反应峰值的数据。血清和唾液激素水平将通过市场上可获得的实验室分析试剂盒进行测定。平均心率将根据脉搏血氧仪数据计算；心率变异性将根据总值、低频和高频值以及低/高频比率计算。哭泣的持续时间将由Tandy声控记录器测量，PIPP将由一名对治疗条件视而不见的训练有素的观察员进行评分。心率变异将使用快速傅立叶变换进行分析，如果测量值为正态分布，则将使用非配对T检验来分析所有其他结果。如果正态假设被违反，则在应用T检验之前将使用适当的变换。

DESCRIPTION (provided by applicant): Twenty-four preterm infants 30-32 weeks gestational age and between 2-9 days postnatal age will be recruited for a cross-over design study to test the effect of Kangaroo Care (KC), skin -to - skin holding of the diaper-clad infant by the mother, on blunting physiologic, hormonal, and behavioral responses to heel stick. Heel stick is the most common repetitive painful procedure hospitalized premature infants experience. Pain experiences, both acute and chronic, are associated with impaired neurologic and immunologic functioning. Kangaroo Care may be an additional pain management intervention should it have an effect on blunting heart rate (HR), plasma and salivary cortisol, Premature Infant Pain Profile (PIPP) score and crying duration as well as increasing heart rate variability (HRV) in response to heelstick pain. Data will be collected over two days with all heelsticks occurring at 11:00 a.m. as part of routine blood draws for the daily labs. Infants are randomly assigned to group A (KC on Day 1, routine incubator care Day 2) or group B (routine incubator care Day 1, KC on Day 2). Infants will lie in an incubator for routine incubator care from 10:00-11:30, having the heel stick in the incubator; on the KC day infants will be in KC from 10:00 - 11:30 a.m. and have the heel stick done in KC. For both groups, at 10:45 a.m., HR and HRV recording, voice-activated recording for cry duration, videotaping for PIPP, and behavioral state measures (an intervening variable) will begin. At 11:00 a.m. a salivary cortisol sample and then a plasma cortisol sample are obtained. A second salivary cortisol sample will be obtained 21-minutes post-heelstick. At the end of the second salivary cortisol sampling, HR, HRV, cry duration, and behavioral state measurements cease. PIPP is scored for each phase of the heel stick sequence. Salivary cortisol correlates well with serum levels and will provide data on peak hormonal responses that occur 20-21 minutes after heelstick. Serum and salivary hormone levels will be determined by commercially available laboratory assay kits. Mean HR will be calculated from the pulse oximeter data; HRV will be computed for a total value, low and high frequency values, and ratio of low: high frequency. Duration of crying will be measured by the Tandy voice activated recorder and PIPP will be scored by a trained observer who is blind to treatment conditions. HRV will be analyzed with Fast Fourier Transformation and with all other outcomes, will be analyzed using an unpaired T-test if measurements are normally distributed. If the normality assumption is violated, an appropriate transformation will be used before applying the T-test.