METHODS: This study protocol is for a single-centre, two-arm, parallel-group, double-blind and non-inferiority randomised controlled trial. Participants will be recruited from a NICU in a teriary class A hospital in China, and eligible infants will be randomly allocated to either the glycerine (mL): saline (mL) group in a 3:7 ratio or the 1:9 ratio group. The enema procedure will adhere to the standardised operational protocols. Primary outcomes encompass necrotising enterocolitis and rectal bleeding, while secondary outcomes encompass feeding parameters, meconium passage outcomes and splanchnic regional oxygen saturation. Analyses will compare the two trial arms based on an intention-to-treat allocation.
BACKGROUND: This trial is approved by the ethics committee of the Medical Ethics Committee of West China Second University Hospital of Sichuan University. The results will be published in a peer-reviewed journal.
BACKGROUND: ChiCTR2300079199.
方法:本研究方案是针对单中心,双臂,平行组,双盲和非劣效性随机对照试验。参与者将从中国一家三级甲等医院的NICU招募,符合条件的婴儿将被随机分配到甘油(mL):盐水(mL)组,比例为3:7或1:9。灌肠程序将遵守标准化的操作协议。主要结局包括坏死性小肠结肠炎和直肠出血,而次要结果包括喂养参数,胎粪通过结果和内脏区域氧饱和度。分析将根据意向治疗分配比较两个试验组。
背景:本试验经四川大学华西第二医院医学伦理委员会伦理委员会批准。结果将发表在同行评审的期刊上。
背景:ChiCTR2300079199。