Ibrahim Thowfique, Li Wei Chiang, Bautista Dianne, Sriram Bhavani, Xiangzhen Fay Li, Rajadurai Victor Samuel
Department of Neonatology, KK Women's and Children's Hospital, Singapore, Singapore.
Neonatology. 2017;112(4):347-353. doi: 10.1159/000477999. Epub 2017 Aug 3.
Meconium retention is associated with feeding intolerance. Trials using glycerol and Gastrografin to expedite the evacuation of meconium have failed to generate clinically valid results for efficacy and safety.
We assessed the feasibility of aggressive meconium evacuation with saline rectal washout (RW) in very-low-birth-weight infants to reduce the time it took them to reach full enteral feeds.
We conducted an open-label, pilot, randomized controlled trial (RCT) (birth weight stratified, i.e., to 750-999 g and 1,000-1,500 g) of early aggressive meconium evacuation with twice-daily normal saline RW compared to conventional management with glycerin suppositories (GS), until full enteral feeds (110 mL/kg/day) were reached. Primary outcome was time to reach full enteral feeds. Safety, process, and secondary efficacy outcomes were also evaluated.
Sixty-one infants were randomized, 28 to RW and 33 to GS. The process and feasibility outcomes were met. RW was found to be safe; none of the RW-randomized infants developed necrotizing enterocolitis (≥ stage II) or complications secondary to RW. Evidence of efficacy was supported: in the 750-999 g stratum (n = 15), the median time to full enteral feeds was shorter with RW (11.0 days, 95% CI: 10.4-11.6) than with GS (15.6 days, 95% CI: 13.0-18.2) by a reduction of 4.6 days (p = 0.027). In the 1,000-1,500 g stratum (n = 46), there was no evidence of benefit: RW 10.2 days (95% CI 8.3-12.1) and GS 10.1 days (95% CI 9.3-10.9, p = 0.304).
Our protocol was feasible and an adequately powered RCT is required to confirm the findings of this trial.
胎粪潴留与喂养不耐受有关。使用甘油和泛影葡胺来加速胎粪排出的试验未能得出关于疗效和安全性的临床有效结果。
我们评估了在极低出生体重儿中采用生理盐水直肠冲洗（RW）积极排出胎粪以缩短其达到完全肠内喂养所需时间的可行性。
我们进行了一项开放标签、试点、随机对照试验（RCT）（按出生体重分层，即750 - 999克和1000 - 1500克），将每日两次用生理盐水进行早期积极胎粪排出的RW与使用甘油栓（GS）的传统管理方法进行比较，直至达到完全肠内喂养（110毫升/千克/天）。主要结局是达到完全肠内喂养的时间。还评估了安全性、过程和次要疗效结局。
61名婴儿被随机分组，28名接受RW，33名接受GS。达到了过程和可行性结局。发现RW是安全的；接受RW随机分组的婴儿中没有发生坏死性小肠结肠炎（≥II期）或RW继发的并发症。疗效证据得到支持：在750 - 999克分层（n = 15）中，RW组达到完全肠内喂养的中位时间（11.0天，95%CI：10.4 - 11.6）比GS组（15.6天，95%CI：13.0 - 18.2）短4.6天（p = 0.027）。在1000 - 1500克分层（n = 46）中，没有获益证据：RW为10.2天（95%CI 8.3 - 12.1），GS为10.1天（95%CI 9.3 - 10.9，p = 0.304）。
我们的方案是可行的，需要进行一项有足够效力的RCT来证实本试验的结果。
