Weiss Elliott Mark, Duenas Devan M, Kelsh Andrea, Gray Megan M, Oslin Ellie, Mcneil Devinae, Juul Sandra E, Kraft Stephanie A
Treuman Katz Center for Pediatric Bioethics and Palliative Care, Seattle Children's Research Institute, Seattle, WA, USA.
Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
J Perinatol. 2025 Mar 4. doi: 10.1038/s41372-025-02245-w.
Recruiting for neonatal clinical trials is difficult for families and participation rates are low. We partnered with the DIVI (Darbepoetin plus slow-release IntraVenous Iron) trial for pilot feasibility evaluation of the BRIEF (Better Research Interactions for Every Family) intervention.
Pre/post design to compare infant data and parent surveys and interviews before and after the BRIEF intervention as well as comparing DIVI enrolled and DIVI not enrolled.
Enrollment rates and parental experiences were similar in pre- and post-BRIEF eras. Most respondents reported positive interactions with researchers. Parents who declined DIVI reported somewhat worse experiences compared to those who enrolled. Interview respondents reported widely variable experiences. The narrow enrollment window emerged as particularly important to parents' recruitment experience.
The BRIEF intervention was well received and is ready for larger scale testing to assess its impact on parental experience and enrollment rates. Future work should address short enrollment windows common in neonatal clinical trials.
新生儿临床试验的招募工作对家庭来说困难重重，参与率较低。我们与DIVI（促红细胞生成素与缓释静脉铁剂）试验合作，对BRIEF（为每个家庭提供更好的研究互动）干预措施进行试点可行性评估。
采用前后设计，比较BRIEF干预措施实施前后的婴儿数据以及家长调查和访谈结果，并比较参与DIVI试验和未参与DIVI试验的情况。
在BRIEF干预前后，入组率和家长体验相似。大多数受访者表示与研究人员有积极的互动。拒绝参与DIVI试验的家长所报告的体验比参与试验的家长略差。访谈受访者报告的体验差异很大。狭窄的招募窗口对家长的招募体验尤为重要。
BRIEF干预措施受到好评，准备进行更大规模的测试，以评估其对家长体验和入组率的影响。未来的工作应解决新生儿临床试验中常见的招募窗口短的问题。
