Kangaroo Care to Blunt Pain in Premature Infants

描述（由申请人提供）：将招募24名30-32周孕龄和出生后2-9天的早产儿进行交叉设计研究，以测试袋鼠式护理（KC）的效果，即母亲对穿着尿布的婴儿进行皮肤对皮肤的呵护，以钝化婴儿对鞋跟贴的生理、激素和行为反应。脚后跟粘是住院早产儿最常见的重复性疼痛手术。急性和慢性疼痛都与神经和免疫功能受损有关。袋鼠式护理可能是一种额外的疼痛管理干预，如果它对降低心率（HR）、血浆和唾液皮质醇、早产儿疼痛特征（PIPP）评分和哭闹持续时间以及增加心率变异性（HRV）对高跟鞋疼痛的反应有影响。数据将在两天内收集，所有的鞋跟测试都在上午11点进行，作为日常实验室常规抽血的一部分。婴儿随机分为A组（第1天KC，第2天常规培养箱护理）或B组（第1天常规培养箱护理，第2天KC）。10:00-11:30，婴儿躺在培养箱中进行常规培养箱护理，脚后跟贴在培养箱中；在KC日，婴儿将于上午10点至11点30分在KC，并在KC完成跟棒。对于两组，上午10点45分开始进行HR和HRV记录，哭声持续时间的声控记录，PIPP录像和行为状态测量（一个干预变量）。上午11点采集唾液皮质醇样本和血浆皮质醇样本。第二次唾液皮质醇样本将在穿高跟鞋21分钟后获得。在第二次唾液皮质醇取样结束时，心率、HRV、哭泣持续时间和行为状态测量停止。对每个阶段的跟贴顺序进行PIPP评分。唾液皮质醇与血清水平密切相关，并将提供鞋跟后20-21分钟的峰值激素反应数据。血清和唾液激素水平将由市售实验室检测试剂盒测定。平均HR将根据脉搏血氧仪数据计算；将计算HRV的总价值，低和高频值，和低：高频的比率。哭泣的持续时间将由Tandy声控记录仪测量，PIPP将由一个对治疗条件一无所知的训练有素的观察者评分。HRV将使用快速傅立叶变换进行分析，如果测量值为正态分布，则使用非配对t检验进行分析。如果违反正态性假设，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.