Evaluation of Splanchnic Oximetry,Doppler Flow Velocimetry in the Superior Mesenteric Artery and Feeding Tolerance in VERY LOW BIRTH WEIGHT IUGR and NON-IUGR Infants Receiving Bolus Versus Continuous Enteral Nutrition
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
研究概览
简要总结
This study aims at recruiting about twenty very low birth weight infants, either intrauterine growth restricted (IUGR) or NON-IUGR
STRATIFICATION:Population will be stratified in two groups: IUGR infants (approximately 10 children) and NON-IUGR infants (approximately 10 children).
PRIMARY ENDPOINT:To evaluate the changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
SECONDARY ENDPOINT:
- To compare if changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;
- To compare growth and nutritional status of the 2 groups by randomized arm.
- To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of Near Infrared Spectroscopy (NIRS). After birth, in the first 24 hours of life, and in the transitional period, between the 48th and 72nd hours of life, all infants' intestinal perfusion will be evaluated with NIRS and a doppler of the superior mesenteric artery will be executed.
- To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance (need of interruption of enteral feeding).
DESIGN: This is a randomized, non-pharmacological, single-center, cross-over study including 20 VLBW babies. Duration of the study: 24 months.
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 (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- Pre-existing cutaneous disease not allowing the placement of the probe
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight at birth ranging: 700 - 1501 grams;
- •Gestational age up to 25 weeks and 6 days;
- •Written informed consent from parents or guardians.
排除标准
- •Major congenital abnormality (severe heart or cerebral disease, chromosomopathies, severe renal malformations, any malformation or disease of the gastroenteric tract)
- •Significant multi-organ failure prior to trial entry (perinatal asphyxia with renal, cardiac or cerebral impairment, DIC)
- •Pre-existing cutaneous disease not allowing the placement of the probe
结局指标
主要结局
changes in the intestinal perfusion determined by feeding in VLBW infants fed by 3 hours nasogastric nutrition (CN) or by bolus (BN).
时间窗: 3 hours
Evaluation of oximetry with splanchnic NIRS (difference of CSOR values and of rSO2s values) and perfusion with doppler of superior mesenteric artery (differences of peak sistolic and end-diastolic velocity, mean velocity, and pulsatility index) before, during ad after feeding.
次要结局
- To compare of changes in the intestinal perfusion induced by feeding are different between IUGR and NON-IUGR infants;(2 weeks; it's an average;it depends on the time necessary to achieve an enteral intake of 100 mL/Kg/die)
- • To compare growth and nutritional status of the 2 groups by randomized arm.(2 months; it's an average;it depends on the time necessary to achieve the full enteral feeding and the 36th weeks of postconceptional age)
- • To evaluate if changes of intestinal perfusion and oximetry induced by feeding are related to baseline (< 72 hours of life) values of Doppler flow velocimetry and of NIRS.(2 weeks)
- • To test if changes in intestinal oximetry and perfusion can be reliable predictors of feeding intolerance(1 month; it's an average;it depends on the time necessary to achieve the full enteral feeding)
研究者
Valentina Bozzetti
Dr.
San Gerardo Hospital