Chioma Roberto, Ghirardello Stefano, Włodarczyk Krzysztof, Ulan-Drozdowska Joanna, Spagarino Antonio, Szumska Marta, Krasuska Klaudia, Seliga-Siwecka Joanna, Philip Roy K, Al Assaf Niazy, Pierro Maria
Department of Woman and Child Health and Public Health, Neonatology Unit, Università Cattolica del Sacro Cuore, Rome, Italy.
Department of Woman and Child Health and Public Health, Neonatology Unit, Ospedale San Matteo, Pavia, Italy.
Front Pediatr. 2023 Jun 9;11:1049014. doi: 10.3389/fped.2023.1049014. eCollection 2023.
There is a lack of consensus on the management of thrombocytopenia in preterm infants, and the threshold for prophylactic platelet transfusion varies widely among clinicians and institutions. Reports in animal models suggested that platelets may play a relevant role in lung alveolarization and regeneration. Bronchopulmonary dysplasia (BPD) is a severe respiratory condition with a multifactorial origin that affects infants born at the early stages of lung development. Recent randomized controlled trials on the platelets count threshold for prophylactic transfusions in preterm infants with thrombocytopenia suggest that a higher exposition to platelet transfusion may increase the risk of BPD. Here, we report a protocol for a systematic review, which aims to assist evidence-based clinical practice and clarify if the administration of platelet products may be associated with the incidence of BPD and/or death in preterm infants.
MEDLINE, Embase, Cochrane databases, and sources of gray literature for conference abstracts and trial registrations will be searched with no time or language restrictions. Case-control studies, cohort studies, and nonrandomized or randomized trials that evaluated the risk for BPD and/or death in preterm infants exposed to platelet transfusion will be included. Data from studies that are sufficiently similar will be pooled as appropriate. Data extraction forms will be developed . Observational studies and nonrandomized and randomized clinical trials will be analyzed separately. Odds ratio with 95% confidence interval (CI) for dichotomous outcomes and the mean difference (95% CI) for continuous outcomes will be combined. The expected heterogeneity will be accounted for using a random-effects model. Subgroup analysis will be performed based on -determined covariate of interest. In case of sufficient homogeneity of interventions and outcomes evaluated, results from subgroups of studies will be pooled together in a meta-analysis.
This systematic review will investigate the association of BPD/death with platelet components administration in preterm infants, and, consequently, it will provide reliable indications for the evidence-based management of premature patients with thrombocytopenia.
对于早产儿血小板减少症的管理缺乏共识,临床医生和机构之间预防性血小板输注的阈值差异很大。动物模型研究表明,血小板可能在肺泡化和肺再生中发挥相关作用。支气管肺发育不良(BPD)是一种多因素起源的严重呼吸系统疾病,影响在肺发育早期出生的婴儿。最近关于血小板减少的早产儿预防性输血血小板计数阈值的随机对照试验表明,较高的血小板输血暴露可能增加BPD的风险。在此,我们报告一项系统评价方案,旨在辅助基于证据的临床实践,并阐明血小板制品的使用是否可能与早产儿BPD和/或死亡的发生率相关。
将检索MEDLINE、Embase、Cochrane数据库以及会议摘要和试验注册的灰色文献来源,无时间或语言限制。纳入评估接受血小板输血的早产儿发生BPD和/或死亡风险的病例对照研究、队列研究以及非随机或随机试验。将对充分相似的研究数据进行适当汇总。将制定数据提取表格。观察性研究以及非随机和随机临床试验将分别进行分析。将合并二分类结局的比值比及其95%置信区间(CI)以及连续结局的平均差(95%CI)。将使用随机效应模型考虑预期的异质性。将基于确定的感兴趣协变量进行亚组分析。如果所评估的干预措施和结局具有足够的同质性,研究亚组的结果将在荟萃分析中汇总在一起。
本系统评价将调查BPD/死亡与早产儿血小板成分输注之间的关联,因此,将为血小板减少的早产儿基于证据的管理提供可靠的指导。