Livingston Michael H, Zequeira Jorge, Blinder Henrietta, Pemberton Julia, Williams Connie, Walton J Mark
McMaster Pediatric Surgery Research Collaborative, McMaster Children's Hospital, Health Sciences Centre Room 4E3, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada ; Clinician Investigator Program, Postgraduate Medical Education, McMaster University, MDCL Rm 3101, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada.
McMaster Pediatric Surgery Research Collaborative, McMaster Children's Hospital, Health Sciences Centre Room 4E3, 1280 Main Street West, Hamilton, Ontario L8S 4K1 Canada ; Division of Pediatric Surgery, University of Puerto Rico School of Medicine, University of Puerto Rico-Medical Sciences Campus, San Juan, 00921 Puerto Rico.
Pilot Feasibility Stud. 2015 Aug 25;1:31. doi: 10.1186/s40814-015-0024-0. eCollection 2015.
Feeding is a significant challenge for premature infants in the neonatal intensive care unit (NICU). These patients are often treated with glycerin suppositories to stimulate the passage of meconium and prevent feeding intolerance. Unfortunately, the evidence for this practice is inconclusive.
METHODS/DESIGN: This protocol is for an external pilot study that will assess the feasibility of a superiority, placebo-controlled, parallel-design, multicenter randomized controlled trial. Participants are premature infants treated in a level 3 NICU with a gestational age 24 to 32 weeks and/or birth weight of 500 to 1500 g. Thirty participants will be recruited as part of this external pilot study. Participants will be randomized to glycerin suppository (250 mg) or placebo starting 48 to 72 h after birth and continuing once daily until meconium evacuation is complete or for a maximum of 12 days. The placebo consists of a 250-mg glycerin suppository placed in the diaper rather than the rectum. Study treatments are administered by the charge nurse on duty who is not otherwise involved in patient care. All other clinicians and research personnel will remain blinded. Outcomes for the pilot study are percentage of eligible participants randomized, percentage of infants reaching full enteral feeds, cost, and treatment-related adverse events (rectal bleeding, rectal perforation, and anal fissure).
This external pilot study will assess the feasibility of a multicenter randomized controlled trial of glycerin suppositories in premature infants. The subsequent multicenter trial will have sufficient power to determine whether this treatment strategy is associated with decreased time to full enteral feeds.
ClinicalTrials.gov: NCT02153606.
对于新生儿重症监护病房（NICU）中的早产儿而言，喂养是一项重大挑战。这些患儿常使用甘油栓来促进胎粪排出并预防喂养不耐受。遗憾的是，这种做法的证据并不确凿。
方法/设计：本方案用于一项外部预试验研究，该研究将评估一项优效性、安慰剂对照、平行设计、多中心随机对照试验的可行性。研究对象为在三级NICU接受治疗的早产儿，其孕周为24至32周和/或出生体重为500至1500克。作为这项外部预试验研究的一部分，将招募30名研究对象。研究对象将在出生后48至72小时开始随机接受甘油栓（250毫克）或安慰剂治疗，每天一次，直至胎粪排尽或最长持续12天。安慰剂为由置于尿布而非直肠内的250毫克甘油栓组成。研究治疗由值班主管护士实施，该护士不参与患者的其他护理工作。所有其他临床医生和研究人员将保持盲态。预试验研究的结局指标为随机分组的合格研究对象百分比、达到完全肠内喂养的婴儿百分比、成本以及与治疗相关的不良事件（直肠出血、直肠穿孔和肛裂）。
这项外部预试验研究将评估在早产儿中开展甘油栓多中心随机对照试验的可行性。后续的多中心试验将有足够的效力来确定这种治疗策略是否与缩短完全肠内喂养时间相关。
ClinicalTrials.gov：NCT02153606。
