A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
研究概览
简要总结
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.
详细描述
In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis.
However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants.
This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Open label during intervention, assessor of outcomes will be blinded to group allocations
入排标准
- 年龄范围
- 26 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Preterm neonate, born between 26+0 and 30+0 weeks of gestation
- •Birth weight below 1500g
- •Parental informed consent obtained
排除标准
- •Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)
- •Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l
- •Circulatory instability requiring treatment with inotropes
- •Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)
- •Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations
结局指标
主要结局
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)
时间窗: 5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached
Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day
次要结局
- Total duration of parenteral infusion(Through first (on average) two to three weeks of the study until full enteral feeding is achieved.)
- Withholding of enteral feeding(Through first (on average) two to three weeks of the study until full enteral feeding is achieved.)
- Spontaneous intestinal perforation(Duration of hospitalization, an average of 8-15 weeks)
- Necrotizing enterocolitis(Duration of hospitalization, an average of 8-15 weeks)
- Bronchopulmonary dysplasia(At timepoint of reached 36 gestational weeks of the neonate)
- Neurodevelopment(Follow up at 24 months of corrected age of the child)
- Total duration of indwelling central venous catheter(Through first (on average) two to three weeks of the study until full enteral feeding is achieved.)
- Hypoglycaemia(Through first (on average) two to three weeks of the study until full enteral feeding is achieved.)
- Late onset sepsis(Duration of hospitalization, an average of 8-15 weeks)
- Intraventricular and periventricular haemorrhage(Duration of hospitalization, an average of 8-15 weeks)
- Retinopathy of prematurity(Duration of hospitalization, an average of 8-15 weeks)