DECREASE OF CHOLESTASIS USING CYCLED PARENTERAL NUTRITION IN NEWBORNS REQUIRING PROLONGED PARENTERAL NUTRITION
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- % patients with parenteral nutrition associated cholestasis (PNAC)
研究概览
简要总结
The aim of our study is to compare the incidence of PNAC in newborns receiving cyclic versus continuous parenteral nutrition (PN) in those newborns who need prolonged PN. The secondary aims are to compare incidence of sepsis and catheter related sepsis, mean length of hospital stay, mortality, nutritional status at two years of chronological age and predisposing factors to the development of parenteral nutrition associated cholestasis (PNAC) between the two groups, and to evaluate the adverse effects of the method of cycling used.
This was a single-center, prospective randomized not blinded study was conducted in a level 3 neonatal intensive care unit from July 2010 to January 2015. Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians were excluded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Days 至 50 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns who needed long-term PN for more than ten days and were diagnosed with a pathology that makes likely the need to extend it.
排除标准
- •Infants with hemodynamic instability until a stable situation, congenital hepatic disease, preterm infants with diagnosis of respiratory distress syndrome or persistent ductus arteriosus and lack of authorization from the parents or guardians
研究组 & 干预措施
Intervention: Cyclic parenteral nutrition Cohort
All newborn who were included in the study to receive cyclic parenteral nutrition (within 24 hours). The parenteral nutrition was stopped for one hour the first day until 4 hours in preterm infants and 6 hours in term neonates.
干预措施: Cyclic parenteral nutrition (Procedure)
Control: Continuous parenteral nutrition
All newborn who were included in the study to receive continuous parenteral nutrition (24 hours). The parenteral nutrition was given by a central line in 24 hours with a basal flow
结局指标
主要结局
% patients with parenteral nutrition associated cholestasis (PNAC)
时间窗: through study completion, an average of 1 year
The incidence of parenteral nutrition associated cholestasis in newborns receiving cyclic versus continuous PN in those newborns who need prolonged PN.
次要结局
- Adverse effects of the method of cycling used(through study completion, an average of 1 year)
- Nutrition factors to the development of PNAC(through study completion, an average of 1 year)
- Anticholestatic drugs(through study completion, an average of 1 year)
- Mortality(through study completion, an average of 1 year)
- Incidence of sepsis(through study completion, an average of 1 year)
- Incidence of catheter related sepsis (CRS)(through study completion, an average of 1 year)
- Mean length of hospital stay(through study completion, an average of 1 year)
研究者
Manuel Sanchez Luna
Clinical Professor
Hospital General Universitario Gregorio Marañon