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临床试验/NCT02383264
NCT02383264已完成不适用

Splanchnic Oxygenation Patterns in Response to the First Enteral Feed in Preterm Infants: Prediction of Feeding Tolerance and Correlation With Abnormal Antenatal Doppler.

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
试验地点
1
主要终点
Increase/reduction of abdominal rSO2 values after the first enteral feed in infants at high risk of feeding intolerance.

研究概览

简要总结

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants is still a challenge for neonatologists. Due to the immaturity of the gastrointestinal tract, preterm infants are at high risk of developing feeding intolerance (FI) or necrotizing enterocolitis (NEC), which is the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts clinicians to withhold, decrease or discontinue enteral feeds; thus, the establishment of an adequate early enteral nutrition is frequently hampered. Early identification of preterm infants at high risk for gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding.

Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2). A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been reported. To date, however, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been yet established.

This observational prospective study aims:

  • to assess abdominal rSO2 patterns in response to the first bolus feed;
  • to evaluate possible correlations with subsequent development of gastrointestinal complications.

详细描述

Enteral nutrition of preterm and intrauterine growth-restricted (IUGR) infants remains a major challenge for neonatologists. Early introduction of minimal enteral feeding (MEF) enhances gut hormones release, reduces the intestinal permeability and improves the motility of the intestinal tract, thus promoting gut functional maturation. Due to gastrointestinal immaturity, however, preterm infants are likely to develop clinical symptoms of feeding intolerance (FI), such as abdominal distention, vomiting, abundant and/or bilious gastric residuals, occult or gross bloody stools. FI could represent an early sign of necrotizing enterocolitis (NEC), the most feared gastrointestinal complication of prematurity. The occurrence of FI often prompts neonatologists to withhold, decrease or discontinue enteral feeds, thus hampering the establishment of an adequate early enteral nutrition.

Early identification of preterm infants at high risk of gastrointestinal complications could help clinical decisions on the introduction and the advancement of enteral feeding. The administration of the first feed in healthy preterm infants leads to a post-prandial increase of superior mesenteric artery (SMA) blood flow, detected by Doppler ultrasound. A significant correlation between early feeding tolerance and increased SMA blood flow velocity has been further observed one hour after the first feed.

Near-infrared spectroscopy (NIRS) provides a non-invasive monitoring of regional oxygen saturation (rSO2) and has been previously used to evaluate mesenteric perfusion in preterm infants at increased risk for intestinal complications. Abdominal rSO2 detected by NIRS has been shown to effectively reflect mesenteric blood flow changes. A significant correlation between lower abdominal rSO2 values in the first week of life and subsequent NEC development has been recently observed in a cohort of preterm infants, confirming previous data from animal models.

Current evidences on the role of NIRS monitoring in predicting FI development are still limited. To date, indeed, splanchnic oxygenation patterns in response to the first bolus feed and possible correlations with subsequent FI development have not been established yet.

The aim of this study is to assess abdominal rSO2 patterns in response to the first bolus feed and to evaluate possible correlations with the development of gastrointestinal complications.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Day 至 30 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Gestational age ≤34 weeks
  • •Stable clinical conditions

排除标准

  • •Any enteral feeding prior to the enrollment.
  • •Major congenital abnormalities
  • •Central nervous system diseases
  • •Hypoxic injury
  • •Hemodynamic instability, hypotension, patent ductus arterioles, anemia, sepsis or other infections at time of first feed.
  • •Antenatal Doppler impairment.

结局指标

主要结局

Increase/reduction of abdominal rSO2 values after the first enteral feed in infants at high risk of feeding intolerance.

时间窗: 3.5 hours

Increase/reduction of abdominal rSO2 values in response to the first enteral feed in infants who have further developed feeding intolerance during their hospitalization.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Corvaglia

Associate Professor, University of Bologna (Italy)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

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