PDF(Pubmed)
Abstract：
BACKGROUND: Various approaches are employed to expedite the passage of meconium in preterm infants within the neonatal intensive care unit (NICU), with glycerine enemas being the most frequently used. Due to the potential risk of high osmolality-induced harm to the intestinal mucosa, diluted glycerine enema solutions are commonly used in clinical practice. The challenge lies in the current lack of knowledge regarding the safest and most effective concentration of glycerine enema. This research aims to ascertain the safety of different concentrations of glycerine enema solution in preterm infants.
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.
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.
摘要：
背景：在新生儿重症监护病房（NICU）内，采用了各种方法来加快早产儿胎粪的通过，甘油灌肠是最常用的。由于高渗透压对肠粘膜造成伤害的潜在风险，稀释的甘油灌肠溶液通常用于临床实践。挑战在于目前缺乏关于最安全和最有效的甘油灌肠剂浓度的知识。本研究旨在确定不同浓度的甘油灌肠溶液在早产儿中的安全性。
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。
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。
