McMaster Pediatric Surgery Research Collaborative.
Division of Pediatric Surgery, McMaster University, Hamilton, ON, Canada.
J Neonatal Perinatal Med. 2020;13(4):495-505. doi: 10.3233/NPM-190310.
Glycerin suppositories are often used to facilitate meconium evacuation in premature infants. The evidence for this practice is inconclusive. The purpose of this study was to assess the feasibility of a multicenter randomized controlled trial on the effectiveness of this treatment strategy.
We conducted an external pilot study for a multicenter randomized controlled trial of premature infants randomized to glycerin suppositories or placebo procedure. Participants were included if they were gestational age of 24 weeks 0 days to 31 weeks 6 days and/or birthweight of 500 to 1500 grams. We excluded infants with life-threatening congenital anomalies, contraindications to receiving suppositories, or signs of clinical instability. Outcomes included cost, recruitment, and treatment-related adverse events.
A total of 109 were screened, 79 were initially eligible, and 34 consented to participate. Four of these infants were excluded prior to randomization due to thrombocytopenia, 30 were randomized, and 26 reached full enteral feeds. Three infants (10%) experienced rectal bleeding 5 to 43 days after completing study treatments. An anal fissure was noted in two of these patients. There were no cases of rectal perforation but one infant assigned to active treatment developed necrotizing enterocolitis.
Conducting a multicenter randomized controlled trial on the use of glycerin suppositories in premature infants is feasible. Minor modifications to the study protocol are needed to increase participant recruitment and simplify the administration of study treatments.
甘油栓剂常用于促进早产儿胎粪排出。但目前尚无定论。本研究旨在评估在早产儿中使用甘油栓剂治疗策略的有效性的多中心随机对照试验的可行性。
我们对早产儿进行了一项多中心随机对照外部试验，随机分配甘油栓剂或安慰剂治疗。纳入的研究对象胎龄为 24 周 0 天至 31 周 6 天，或出生体重为 500 至 1500 克。排除有危及生命的先天性异常、禁忌使用栓剂或有临床不稳定迹象的婴儿。结局包括成本、招募和与治疗相关的不良事件。
共筛选了 109 例，79 例最初符合纳入标准，34 例同意参与。其中 4 例婴儿因血小板减少在随机分组前被排除，30 例婴儿被随机分组，26 例婴儿达到全肠内喂养。3 例（10%）婴儿在完成研究治疗后 5 至 43 天出现直肠出血。其中 2 例患儿出现肛裂。无直肠穿孔病例，但 1 例接受活性治疗的婴儿发生坏死性小肠结肠炎。
在早产儿中开展甘油栓剂使用的多中心随机对照试验是可行的。需要对研究方案进行一些小的修改，以增加参与者的招募，并简化研究治疗的管理。
