Routine Aspiration of Residual Gastric Contents in Very Low Birth Weight Infants

描述(由申请人提供)：早产极低出生体重(VLBW)婴儿出生后头几周充分的肠内营养的重要性是众所周知的，也是促进最佳生长和发育以及减少早产相关和医源性并发症所必需的。常规抽吸潜在残胃内容物(RGC)传统上是在这些婴儿每次喂养之前进行的。容量增加被认为与喂养不耐受或坏死性小肠结肠炎的早期症状有关。在危重儿童和成人中，体量的增加也被认为与胃分泌物的呼吸吸入有关。然而，没有确凿的证据表明这种做法改善了护理或减少了并发症，实际上可能会导致并发症，包括延迟实现完全肠道喂养。与延迟达到完全肠道喂养相关的潜在并发症包括更多地使用肠外营养(PN)、肠外营养相关性肝病(PNALD)、生长不良、需要中心静脉导管(CVL)的时间更长、晚发型败血症(LOS)风险增加、住院时间延长以及胃肠道(GI)完整性和功能障碍。 这项为期4年的研究的总体目标是确定省略潜在RGC的常规抽吸是否能改善极低出生体重早产儿的营养结局。这项拟议的研究将跟踪一组种族和经济上不同的早产儿在出生后6周内的前瞻性队列(N=120)。目的1确定吸入RGC的风险和益处，以及在肠内喂养前不抽吸RGC对早产儿营养结局的临床益处，包括每周肠道摄入量、达到完全肠内喂养的时间、生长指数、TPN时间、PNALD发生率、CVL时间、LOS发生率和住院时间。对于目标2，常规RGC抽吸对胃肠道粘膜出血和炎症的影响将通过测量血液和粪便中的钙保护素来确定。在目标3中，吸入RGC对胃肠功能的影响将通过血清胃泌素和胃动素水平来衡量。所有登记的婴儿都将得到相同的护理，但有一个例外。随机分配到控制组的受试者将继续在每次喂奶前例行抽吸潜在的RGC，而试验组的受试者则不会。将在6周内对成果措施进行监测。研究结果有望填补早产儿喂养前吸入RGC的必要性、吸入RGC是否影响短期和长期结局以及常规吸入RGC是否对早产儿有害的研究空白。

DESCRIPTION (provided by applicant)::The importance of adequate enteral nutrition during the first few weeks following birth in premature very low birth weight (VLBW) infants is well known and necessary to facilitate optimal growth and development and reduce both premature birth-related and iatrogenic complications. Routine aspiration of potential residual gastric contents (RGC) has traditionally been performed prior to every feeding in these infants. Increased volumes have been thought to be related to feeding intolerance or an early symptom of necrotizing enterocolitis. In critically ill children and adults increased volumes have also bee thought to be associated with respiratory aspiration of gastric secretions. However, there is no conclusive evidence that this practice improves care or reduces complications and may actually contribute to complications including a delay in achievement of full enteral feedings. Potential complications related to delaying attainment of full enteral feedings include increased use of parenteral nutrition (PN), parenteral nutrition associated liver disease (PNALD), poor growth, more hours requiring a central venous line (CVL), increased risk of late onset sepsis (LOS), prolonged hospitalization, as well as disturbances in gastrointestinal (GI) integrity and function. The overall objective of this 4-year study is to determine whether omission of routine aspiration of potential RGC improves nutritional outcomes of VLBW premature infants. The proposed study will follow a prospective cohort (N = 120) of racially and economically diverse premature VLBW infants for 6 weeks following birth. Aim 1 will determine the risks and benefits of aspirating RGC and the clinical benefits of omitting aspiration of RGC prior to enteral feedings on nutritional outcomes of premature VLBW infants including weekly enteral intake, time to reach full enteral feedings, growth indices, hours of TPN, incidence of PNALD, hours with a CVL, incidence of LOS, and length of stay. For Aim 2, the effect of routine RGC aspiration on GI mucosal bleeding and inflammation will be determined through measurement of blood and calprotectin in the stool. The effect of aspiration of RGC on GI function will be measured using serum levels of the peptides gastrin and motilin in Aim 3. All enrolled infants will receive the same care with one exception. Those randomly assigned to the Control Group will continue to have routine aspiration of potential RGC prior to every feeding and those in the Experimental Group will not. Outcomes measures will be monitored over 6 weeks. Results are expected to fill an important gap in research regarding the necessity of aspirating RGC prior to feeding in premature VLBW infants, whether aspiration of RGC influences short and long term outcomes and whether routine aspiration of RGC is detrimental to premature VLBW infants.