Very Early and Early Nutrition in Acute Pancreatitis in Children: a Randomized Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Length of hospitalization
研究概览
简要总结
The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests and pain severity will be evaluated.
详细描述
Prospective, randomized study. Research in the adult population shows that early enteral feeding in acute pancreatitis (AP) both oral and via the feeding tube is safe, shortens the length of hospital stay, prevents the multi organ failure (MoF) and reduces mortality. The pediatric population lacks prospective data concerning refeeding modes in AP. The aim of the study is to assess the effect of the early oral refeeding and fat content in the diet on the length of stay, clinical course (included pain severity) in pediatric patients with mild and moderate AP. Patients will be randomized to groups: refeeding within 24 hours or after 24 hours from the hospital admission. Biochemical tests including CRP, amylase, lipase and proinflammatory cytokines levels and zonulin level as well as severity of pain will be assessed again in the second, the third and the fifth hospital day.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AP diagnosis according to the generally accepted criteria ie. fulfilling two out of three criteria:
- •Abdominal pain of pancreatic origin
- •Radiologic findings supportive of AP on imaging
- •Amylase or lipase levels elevation three times above the upper limit of normal
- •Mild or moderate AP Mild AP: AP without organ failure, local or general complications Moderate AP: AP that may be accompanied by intermittent organ failure, local complications or concomitant disease worsening
- •No contradictions to enteral treatment
- •Informed consent from the parents or legal guardian and from the patient if older than 16 years
排除标准
- •Severe general condition
- •Severe AP
- •Kidney insufficiency, cardiac insufficiency
- •Diabetes type 1
- •Cystic fibrosis
- •Contraindications to enteral feeding
- •Lack of required informed consent
研究组 & 干预措施
Very early refeeding
Very early diet intervention: refeeding within 24 hours from the hospital admission.
Participants will be encouraged to start eating immediately after the time of admission. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.
干预措施: Early diet intervention (Other)
Early refeeding
Early diet intervention: refeeding after 24 hours from the hospital admission .
During the first 24 hours after admission participants will be on fluid only (orally and/or intravenously). Later on they will be encouraged to start eating. They will be able to choose the meal from the list with no amount or calories restriction.They will be asked to conduct the daily diet diary - time of feeding, quality and quantity of the foods ingested. Laboratory tests will be performed at the study entry, on the day of 3 and 5 of hospitalization and on the day of discharge.
干预措施: Early diet intervention (Other)
结局指标
主要结局
Length of hospitalization
时间窗: through study completion, an average of 2 years
Number days of hospitalization
次要结局
- Time between the onset of symptoms and the first feeding(assessed at the day of 2)
- Average calories intake(through study completion, an average of 2 years)
- Levels of proinflammatory cytokine levels.(through study completion, an average of 2 years)
- Zonulin level(through study completion, an average of 2 years)
- Adverse events(daily assessment in the first three days of hospitalization)