Feasibility and acceptability of a diagnostic randomized clinical trial of bowel ultrasound in infants with suspected necrotizing enterocolitis

被引:0
作者
Alain Cuna
Sherwin Chan
Jill Jones
Maura Sien
Amie Robinson
Karishma Rao
Erin Opfer
机构
[1] Children’s Mercy Kansas City,Division of Neonatology
[2] University of Missouri-Kansas City,School of Medicine
[3] Children’s Mercy Kansas City,Department of Radiology
[4] University of Kansas Medical Center,Department of Radiology
来源
European Journal of Pediatrics | 2022年 / 181卷
关键词
Sonography; Ultrasound; Necrotizing enterocolitis; Prematurity; Clinical trial;
D O I
暂无
中图分类号
学科分类号
摘要
We conducted a pilot diagnostic randomized clinical trial (RCT) to examine the feasibility, acceptability, and preliminary outcomes of adding bowel ultrasound (BUS) to the diagnostic evaluation for necrotizing enterocolitis (NEC). Infants ≤ 32 weeks’ gestational age with NEC concern were randomized to undergo abdominal X-ray (AXR) or AXR + BUS. The primary outcome was study feasibility. Secondary outcomes included rates of NEC diagnosis and duration of treatment with bowel rest and antibiotics. A total of 56 infants were enrolled; 16 developed NEC concern and were randomized. Rates of recruitment (56/82 = 68%), retention (16/16 = 100%), and protocol compliance (126/127 = 99%) met pre-specified thresholds for feasibility. No significant differences in rates of NEC diagnosis were found between the two groups. Durations of bowel rest and antibiotic treatment were also similar.
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页码:3211 / 3215
页数:4
相关论文
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