Shen Cuncun, Qiu Jingjing, Qiao Yanxia, Chen Huifen, Qin Yaya, Li Junran, Fan Tao, Ma Jing, Zhang Xinrong, Zhou Feng
Department of Neonatology, The Fourth Hospital of Shijiazhuang, Shijiazhuang, China.
J Matern Fetal Neonatal Med. 2025 Dec;38(1):2498559. doi: 10.1080/14767058.2025.2498559. Epub 2025 May 5.
Randomized controlled trials (RCTs) are the gold standard for evaluating efficacy; however, they may contribute to research waste. This study examined the extent of research waste in RCTs involving preterm infants over the past two decades.
This cross-sectional study searched ClinicalTrials.gov between 2001 and 2020 to identify RCTs involving preterm infants. Research waste was defined as the occurrence of any of the following: non-publication, poor reporting, or avoidable design deficiencies. We searched PubMed, Embase, and Google Scholar databases to determine publication status. The CONSORT checklist was used to evaluate the reporting adequacy. Design deficiency was identified based on the risk of bias, evaluated using the Cochrane tool, and the presence of a relevant systematic review.
A total of 100 RCTs were eligible for inclusion. The primary research focus was pulmonary diseases (28%), followed by nutritional (15%) and ophthalmological diseases. Seventy-eight of the 100 RCTs were published and these were likelier to have an enrollment size greater than 300 (26% vs. 5%, = .038). Inadequate reporting was observed in 25 published RCTs, while 47 had design deficiencies. Overall, 69 of the 100 RCTs exhibited at least one feature of research waste. Having a primary investigator from North America or Europe (odds ratio [OR] 0.168, 95% confidence interval [CI] 0.040-0.711, = .015) and an enrollment size greater than 300 (OR 0.074, 95% CI 0.018-0.304, < .001) were independently associated with reduced research waste.
Nearly 70% of RCTs involving preterm infants exhibited features of research waste. However, large-scale RCTs conducted in North America and Europe were less likely to contribute to this issue.
随机对照试验（RCT）是评估疗效的金标准；然而，它们可能导致研究资源浪费。本研究调查了过去二十年中涉及早产儿的随机对照试验的研究资源浪费程度。
这项横断面研究在2001年至2020年期间检索了ClinicalTrials.gov，以识别涉及早产儿的随机对照试验。研究资源浪费被定义为出现以下任何一种情况：未发表、报告不佳或可避免的设计缺陷。我们检索了PubMed、Embase和谷歌学术数据库以确定发表状态。使用CONSORT清单评估报告的充分性。根据使用Cochrane工具评估的偏倚风险以及相关系统评价的存在来识别设计缺陷。
共有100项随机对照试验符合纳入标准。主要研究重点是肺部疾病（28%），其次是营养（15%）和眼科疾病。100项随机对照试验中有78项已发表，这些试验的入组规模更有可能大于300（26%对5%，P = 0.038）。在25项已发表的随机对照试验中观察到报告不充分，而47项存在设计缺陷。总体而言，100项随机对照试验中有69项表现出至少一种研究资源浪费的特征。来自北美或欧洲的主要研究者（优势比[OR] 0.168，95%置信区间[CI] 0.040 - 0.711，P = 0.015）和入组规模大于300（OR 0.074，95% CI 0.018 - 0.304，P < 0.001）与减少研究资源浪费独立相关。
近70%涉及早产儿的随机对照试验表现出研究资源浪费的特征。然而，在北美和欧洲进行的大规模随机对照试验造成这一问题的可能性较小。
