School of Nursing, Faculty of Health, Dalhousie University and IWK Health, Halifax, NS, Canada.
Rankin School of Nursing, St. Francis Xavier University, Antigonish, NS, Canada.
Trials. 2022 Jun 20;23(1):512. doi: 10.1186/s13063-022-06424-4.
Strong evidence suggests that maternal-infant skin-to-skin contact (SSC) is effective in reducing behavioural responses to pain. Given the multi-sensory benefits of SSC, it is highly likely that SSC provided during pain in early life may reduce pain-induced brain activity. The aim of this study is to examine the effect of SSC compared to 24% sucrose on pain-induced activity in the preterm infant brain during a medically required heel lance. Secondary objectives include determining (a) differences between behavioural pain response and noxious-related brain activity during heel lance and (b) rate of adverse events across groups.
We will randomly assign 126 babies (32 to 36 completed weeks gestational age) admitted to the neonatal intensive care unit, and their mothers within the first seven days of age to receive (i) SSC plus sterile water and (ii) 24% oral sucrose. Each baby will receive a medically indicated heel lance, following a no treatment baseline period. The primary outcome is noxious-related brain activity measured using an electroencephalogram (EEG) pain-specific event-related potential. Secondary outcomes include pain intensity measured using a bio-behavioural infant pain assessment tool (Premature Infant Pain Profile-Revised) and rate of adverse events.
This will be the first clinical trial to compare the effect of SSC and 24% sucrose on pain-induced brain activity in the preterm infant brain during a clinical noxious stimulus, measured using EEG. Given the negative neurodevelopmental outcomes associated with unmanaged pain, it is imperative that preterm babies receive the most effective pain-reducing treatments to improve their health outcomes. Our findings will have important implications in informing optimal pain assessment and management in preterm infants.
ClinicalTrials.gov NCT03745963 . Registered on November 19, 2018.
强有力的证据表明，母婴皮肤接触（SSC）可有效减轻婴儿对疼痛的行为反应。鉴于 SSC 的多感官益处，在生命早期的疼痛期间提供 SSC 很可能会降低疼痛引起的大脑活动。本研究的目的是检查 SSC 与 24％蔗糖相比在医学上需要足跟穿刺时对早产儿大脑疼痛引起的活动的影响。次要目标包括确定（a）足跟穿刺期间行为疼痛反应与伤害相关的大脑活动之间的差异，以及（b）各组之间不良事件的发生率。
我们将随机分配 126 名婴儿（32 至 36 周的胎龄）及其母亲进入新生儿重症监护病房，在出生后七天内接受（i）SSC 加无菌水和（ii）24％口服蔗糖。每个婴儿在没有治疗的基线期后，将接受医学指示的足跟穿刺。主要结局是使用脑电图（EEG）疼痛特定事件相关电位测量的伤害相关大脑活动。次要结局包括使用生物行为婴儿疼痛评估工具（改良早产儿疼痛特征）测量的疼痛强度和不良事件发生率。
这将是第一项比较 SSC 和 24％蔗糖对临床有害刺激期间早产儿大脑疼痛引起的大脑活动的影响的临床试验，使用 EEG 进行测量。鉴于未管理的疼痛与负面的神经发育结果相关，因此早产儿必须接受最有效的减轻疼痛的治疗方法，以改善他们的健康结果。我们的研究结果将对早产儿最佳疼痛评估和管理具有重要意义。
ClinicalTrials.gov NCT03745963。于 2018 年 11 月 19 日注册。
