Clifford Vanessa, Klein Laura D, Brown Richard, Sulfaro Christine, Hoad Veronica, Gosbell Iain B, Pink Joanne
Clinical Services and Research and Business Growth & Innovation, Australian Red Cross Lifeblood, Melbourne, Victoria, Australia.
Department of Laboratory Services, Royal Children's Hospital, Melbourne, Victoria, Australia.
J Paediatr Child Health. 2022 Sep;58(9):1629-1634. doi: 10.1111/jpc.16066. Epub 2022 Jul 2.
Australian Red Cross Lifeblood supplies pasteurised donor human milk (PDHM) to more than 30 partner hospitals across Australia. Preterm infants who receive PDHM are a highly vulnerable population but formal biovigilance programs are rare in human milk banking. Lifeblood Milk performs ongoing surveillance for both donor and recipient adverse events. This study aimed to formally review adverse events reported to Lifeblood Milk since 2018.
Milk donor infectious diseases testing outcomes and donor adverse events (DAEs) are prospectively recorded at Lifeblood. Infant recipient adverse events are contractually reported back to Lifeblood Milk by hospitals and assessed according to severity and likelihood of relationship to PDHM administration. Donor and recipient adverse events over a 3.5-year period (July 2018 to December 2021) were reviewed.
There were three DAEs (3/976 = 0.31%) related to phlebotomy; these included two vasovagal reactions and one phlebotomy site haematoma. Eight (8/976 = 0.81%) additional donors had biological false reactive (BFR) infectious diseases serology results. There were 10 reported suspected adverse events in recipients. Six were infection-related; other events included milk curd obstruction, high urinary iodine levels, sudden cardiac death and nasogastric tube obstruction. All reported suspected adverse events in recipients were classified as unlikely to be related, or definitely not related, to PDHM administration.
Milk donor adverse events were rare but biological false reactive serology results were not uncommon. There were no recipient adverse events considered causally related to pasteurised donor human milk, which is generally a low-risk biological product. Ongoing biovigilance remains essential.
澳大利亚红十字会血液服务机构向澳大利亚30多家合作医院供应巴氏消毒的捐赠人乳（PDHM）。接受PDHM的早产儿是一个高度脆弱的群体，但人乳库中正式的生物监测项目很少。血液服务机构的人乳项目对捐赠者和受赠者的不良事件进行持续监测。本研究旨在正式审查自2018年以来向血液服务机构人乳项目报告的不良事件。
在血液服务机构前瞻性记录乳汁捐赠者的传染病检测结果和捐赠者不良事件（DAE）。医院会根据合同要求向血液服务机构人乳项目报告婴儿受赠者的不良事件，并根据严重程度和与PDHM给药的关联可能性进行评估。对3.5年期间（2018年7月至2021年12月）的捐赠者和受赠者不良事件进行了审查。
有3起与静脉穿刺相关的捐赠者不良事件（3/976 = 0.31%）；其中包括2起血管迷走神经反应和1起静脉穿刺部位血肿。另外有8名（8/976 = 0.81%）捐赠者的传染病血清学结果出现生物学假阳性（BFR）。报告了10起受赠者疑似不良事件。6起与感染有关；其他事件包括凝乳阻塞、尿碘水平高、心源性猝死和鼻胃管阻塞。所有报告的受赠者疑似不良事件均被归类为不太可能与PDHM给药有关或肯定与PDHM给药无关。
乳汁捐赠者不良事件很少见，但生物学假阳性血清学结果并不罕见。没有受赠者不良事件被认为与巴氏消毒的捐赠人乳有因果关系，巴氏消毒的捐赠人乳通常是一种低风险的生物制品。持续的生物监测仍然至关重要。
