Department of Neonatal Intensive Care, MBBM Foundation, San Gerardo Hospital, via Pergolesi 33, 20900 Monza, Italy.
BMC Pediatr. 2012 Jul 24;12:106. doi: 10.1186/1471-2431-12-106.
IUGR infants are thought to have impaired gut function after birth, which may result in intestinal disturbances, ranging from temporary intolerance to the enteral feeding to full-blown NEC.In literature there is no consensus regarding the impact of enteral feeding on intestinal blood flow and hence regarding the best regimen and the best rate of delivering the enteral nutrition.
METHODS/DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW infants. Inclusion criteria * Weight at birth ranging: 700-1501 grams * Gestational age up to 25 weeks and 6 days * Written informed consent from parents or guardians Exclusion criteria * Major congenital abnormality * Patients enrolled in other trials * Significant multi-organ failure prior to trial entry * Pre-existing cutaneous disease not allowing the placement of the NIRS' probe. In the first 24 hours of life, between the 48th and 72nd hours of life, and during Minimal Enteral Feeding, all infants' intestinal perfusion will be evaluated with NIRS and a Doppler of the superior mesenteric artery will be executed.At the achievement of an enteral intake of 100 mL/Kg/day the patients (IUGR and NON IUGR separately) will be randomized in 2 groups: Group A (n=10) will receive a feed by bolus (in 10 minutes); then, after at least 3 hours, they will receive the same amount of formula administered in 3 hours. Group B (n=10) will receive a feed administered in 3 hours followed by a bolus administration of the same amount of formula (in 10 minutes) after at least 3 hours. On the randomization day intestinal and cerebral regional oximetry will be measured via NIRS. Intestinal and celebral oximetry will be measured before the feed and 30 minutes after the feed by bolus during the 3 hours nutrition the measurements will be performed before the feed, 30 minutes from the start of the nutrition and 30 minutes after the end of the gavage. An evaluation of blood flow velocity of the superior mesenteric artery will be performed meanwhile. The infants of the Group A will be fed with continuous nutrition until the achievement of full enteral feeding. The infants of the Group B will be fed by bolus until the achievement of full enteral feeding.
Evaluations of intestinal oximetry and superior mesenteric artery blood flow after the feed may help in differentiating how the feeding regimen alters the splanchnic blood flow and oxygenation and if the changes induced by feeding are different in IUGR versus NON IUGR infants.
NCT01341236.
人们认为宫内生长受限（IUGR）的婴儿在出生后肠道功能受损，这可能导致肠道紊乱，从暂时不耐受肠内喂养到完全坏死性小肠结肠炎（NEC）不等。文献中对于肠内喂养对肠道血流的影响尚无共识，因此也没有关于最佳方案和最佳肠内营养输送速度的共识。
方法/设计：这是一项随机、非药物、单中心、交叉研究，纳入了 20 名极低出生体重（VLBW）婴儿。纳入标准：* 出生体重 700-1501 克；* 胎龄 25 周零 6 天；* 父母或监护人书面同意。排除标准：* 重大先天性异常；* 参加其他试验的患者；* 试验前存在多器官功能衰竭；* 存在不允许放置近红外光谱仪探头的皮肤疾病。在生命的头 24 小时内、第 48-72 小时内和在最小肠内喂养期间，将使用近红外光谱仪评估所有婴儿的肠道灌注情况，并对肠系膜上动脉进行多普勒检查。当婴儿达到 100 毫升/千克/天的肠内摄入量时，IUGR 和 NON IUGR 患者将分别随机分为 2 组：A 组（n=10）将接受 10 分钟的推注喂养；然后，至少 3 小时后，他们将接受同样量的配方奶，在 3 小时内给予。B 组（n=10）将接受 3 小时的喂养，然后至少 3 小时后再给予同样量的配方奶推注。在随机分组日，通过近红外光谱仪测量肠道和大脑区域血氧饱和度。在 3 小时的营养期间，通过推注喂养前、喂养后 30 分钟和推注喂养后 30 分钟进行肠道和大脑血氧饱和度测量。同时进行肠系膜上动脉血流速度评估。A 组的婴儿将接受连续营养喂养，直到达到完全肠内喂养。B 组的婴儿将接受推注喂养，直到达到完全肠内喂养。
喂养后评估肠道血氧饱和度和肠系膜上动脉血流有助于区分喂养方案如何改变内脏血流和氧合，以及喂养引起的变化在 IUGR 与 NON IUGR 婴儿之间是否不同。
NCT01341236。
