School of Nursing, Dalhousie University, Halifax, NS, Canada.
BMC Pediatr. 2013 Nov 9;13:182. doi: 10.1186/1471-2431-13-182.
Skin-to-skin contact (SSC) between mother and infant, commonly referred to as Kangaroo Mother Care (KMC), is recommended as an intervention for procedural pain. Evidence demonstrates its consistent efficacy in reducing pain for a single painful procedure. The purpose of this study is to examine the sustained efficacy of KMC, provided during all routine painful procedures for the duration of Neonatal Intensive Care Unit (NICU) hospitalization, in diminishing behavioral pain response in preterm neonates. The efficacy of KMC alone will be compared to standard care of 24% oral sucrose, as well as the combination of KMC and 24% oral sucrose.
METHODS/DESIGN: Infants admitted to the NICU who are less than 36 6/7 weeks gestational age (according to early ultrasound), that are stable enough to be held in KMC, will be considered eligible (N = 258). Using a single-blinded randomized parallel group design, participants will be assigned to one of three possible interventions: 1) KMC, 2) combined KMC and sucrose, and 3) sucrose alone, when they undergo any routine painful procedure (heel lance, venipuncture, intravenous, oro/nasogastric insertion). The primary outcome is infant's pain intensity, which will be assessed using the Premature Infant Pain Profile (PIPP). The secondary outcome will be maturity of neurobehavioral functioning, as measured by the Neurobehavioral Assessment of the Preterm Infant (NAPI). Gestational age, cumulative exposure to KMC provided during non-pain contexts, and maternal cortisol levels will be considered in the analysis. Clinical feasibility will be accounted for from nurse and maternal questionnaires.
This will be the first study to examine the repeated use of KMC for managing procedural pain in preterm neonates. It is also the first to compare KMC to sucrose, or the interventions in combination, across time. Based on the theoretical framework of the brain opioid theory of attachment, it is expected that KMC will be a preferred standard of care. However, current pain management guidelines are based on minimal data on repeated use of either intervention. Therefore, regardless of the outcomes of this study, results will have important implications for guidelines and practices related to management of procedural pain in preterm infants.
ClinicalTrials.gov Identifier: NCT01561547.
皮肤与皮肤接触（SSC），通常被称为袋鼠式护理（KMC），是一种推荐的干预措施，用于减轻程序性疼痛。有证据表明，它在减轻单次疼痛过程中的疼痛方面具有一致的疗效。本研究的目的是研究在新生儿重症监护病房（NICU）住院期间，对所有常规疼痛过程持续进行 KMC 护理，对早产儿行为疼痛反应的持续缓解效果。将单独使用 KMC 与标准护理（24%口服蔗糖）以及 KMC 与 24%口服蔗糖联合使用进行比较。
方法/设计：将被认为有资格接受研究的早产儿纳入研究，纳入标准为胎龄小于 36 6/7 周（根据早期超声）、能够稳定地进行 KMC 护理。采用单盲随机平行分组设计，将参与者随机分配到以下三种干预措施之一：1）KMC，2）KMC 联合蔗糖，3）单独蔗糖，当他们接受任何常规疼痛程序（足跟穿刺、静脉穿刺、静脉、经口/鼻胃管插入）时。主要结局是婴儿的疼痛强度，将使用早产儿疼痛量表（PIPP）进行评估。次要结局是神经行为功能的成熟度，将使用早产儿神经行为评估量表（NAPI）进行评估。在分析中，将考虑胎龄、在非疼痛情况下接受 KMC 的累积暴露量和产妇皮质醇水平。将从护士和产妇的问卷调查中考虑临床可行性。
这将是第一项研究，旨在研究重复使用 KMC 管理早产儿程序性疼痛的效果。这也是第一项比较 KMC 与蔗糖或联合干预的研究。基于大脑阿片类物质依恋理论，预计 KMC 将成为首选的护理标准。然而，目前的疼痛管理指南是基于这两种干预措施的重复使用的最小数据。因此，无论本研究的结果如何，结果都将对与管理早产儿程序性疼痛相关的指南和实践产生重要影响。
ClinicalTrials.gov 标识符：NCT01561547。
