Department of Neonatology, University Children's Hospital Tübingen, Calwerstr. 7, 72076, Tübingen, Germany.
BMC Pediatr. 2021 Oct 18;21(1):454. doi: 10.1186/s12887-021-02905-8.
Enemas are used in preterm infants to promote meconium evacuation, but frequent high-volume enemas might contribute to focal intestinal perforation (FIP). To replace a regime consisting of frequent enemas of varying volume and composition, we implemented a once-daily, low-volume lipid enema (LE) regimen. We investigated its impact on meconium evacuation, enteral nutrition, and gastrointestinal complications in preterm infants.
We performed a single-center retrospective study comparing cohorts of preterm infants < 28 weeks gestation or < 32 weeks, but with birth weight < 10th percentile, before and after implementing LE. Outcomes were rates of FIP, necrotizing enterocolitis (NEC), and sepsis. We assessed stooling patterns, early enteral and parenteral nutrition. We used descriptive statistics for group comparisons and logistic regression to identify associations between LE and gastrointestinal complications and to adjust for group imbalances and potential confounders. Exclusion criteria were gastrointestinal malformations or pre-determined palliative care.
Data from 399 infants were analyzed, 203 before vs. 190 after implementing LE; in the latter period, 55 protocol deviations occurred where infants received no enema, resulting in 3 groups with either variable enemas, LE or no enema use. Rates of FIP and sepsis were 11.9% vs. 6.4% vs. 0.0% and 18.4% vs. 13.5% vs. 14.0%, respectively. NEC rates were 3.0% vs. 7.8% vs. 3.5%. Adjusted for confounders, LE had no effect on FIP risk (aOR 1.1; 95%CI 0.5-2.8; p = 0.80), but was associated with an increased risk of NEC (aOR 2.9; 95%CI 1.0-8.6; p = 0.048). While fewer enemas were applied in the LE group resulting in a prolonged meconium passage, no changes in early enteral and parenteral nutrition were observed. We identified indomethacin administration and formula feeding as additional risk factors for FIP and NEC, respectively (aOR 3.5; 95%CI 1.5-8.3; p < 0.01 and aOR 3.4; 95%CI 1.2-9.3; p = 0.02).
Implementing LE had no clinically significant impact on meconium evacuation, early enteral or parenteral nutrition. FIP and sepsis rates remained unaffected. Other changes in clinical practice, like a reduced use of indomethacin, possibly affected FIP rates in our cohorts. The association between LE and NEC found here argues against further adoption of this practice.
Registered at the German Register of Clinical Trials (no. DRKS00024021 ; Feb 022021).
灌肠用于早产儿以促进胎粪排出，但频繁的大容量灌肠可能导致局部肠穿孔（FIP）。为了替代频繁的、不同容量和成分的灌肠方案，我们实施了每日一次、低容量的脂质灌肠（LE）方案。我们研究了它对早产儿胎粪排出、肠内营养和胃肠道并发症的影响。
我们进行了一项单中心回顾性研究，比较了在实施 LE 前后，胎龄<28 周或<32 周但出生体重<第 10 百分位数的早产儿队列。结局为 FIP、坏死性小肠结肠炎（NEC）和败血症的发生率。我们评估了粪便模式、早期肠内和肠外营养。我们使用描述性统计方法进行组间比较，并使用逻辑回归来确定 LE 与胃肠道并发症之间的关联，并调整组间不平衡和潜在混杂因素。排除标准为胃肠道畸形或预先确定的姑息治疗。
分析了 399 名婴儿的数据，其中 203 名在实施 LE 前，190 名在实施 LE 后；在后一时期，有 55 例婴儿未接受灌肠，出现了方案偏离，导致出现了 3 组，分别为变量灌肠、LE 或不使用灌肠。FIP 和败血症的发生率分别为 11.9%、6.4%、0.0%和 18.4%、13.5%、14.0%。NEC 的发生率分别为 3.0%、7.8%、3.5%。调整混杂因素后，LE 对 FIP 风险无影响（调整后的比值比 1.1；95%CI 0.5-2.8；p=0.80），但与 NEC 风险增加相关（调整后的比值比 2.9；95%CI 1.0-8.6；p=0.048）。虽然 LE 组应用的灌肠次数较少，导致胎粪排出时间延长，但早期肠内和肠外营养无变化。我们发现，吲哚美辛的使用和配方奶喂养分别是 FIP 和 NEC 的其他危险因素（调整后的比值比 3.5；95%CI 1.5-8.3；p<0.01 和调整后的比值比 3.4；95%CI 1.2-9.3；p=0.02）。
实施 LE 对胎粪排出、早期肠内或肠外营养没有明显的临床影响。FIP 和败血症的发生率保持不变。临床实践中的其他变化，如减少吲哚美辛的使用，可能影响了我们队列中 FIP 的发生率。这里发现 LE 与 NEC 之间的关联反对进一步采用这种做法。
在德国临床试验注册处注册（注册号：DRKS00024021；2021 年 2 月）。
