The Effect of Early Versus Standard Central Line Removal on Growth of Very Low Birth Weight Premature Infants: A Non-inferiority, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 214
- 试验地点
- 8
- 主要终点
- Weight at 36 weeks PMA.
研究概览
简要总结
This study compares two different regimens of a central line removal in respect to weight at 36 weeks postmenstrual age in very low birth weight (VLBW) preterm infants. Half of participants will have a central line removed at ≥100 ml/kg/d, while the other half will have a central line removed at ≥ 140 ml/kg/day.
详细描述
Eligible infants will be randomized in equal proportions between two groups. In the first group (group A - early central line removal) central line will be removed at the time the infant reaches 100 ml/kg/d of enteral intake. In the second group (group B - standard central line removal) central line will be removed at the time the infant reaches 140 ml/kg/d of enteral intake (full enteral intake). Central lines will be removed after 3 well tolerated consecutive feedings (assessed by the physician) with no contraindications for central line removal present:
- necessity of administration of drugs that must be given via central venous access,
- necessity of administration of drugs that must be given intravenously along with difficulties to secure peripheral venous access,
- necessity of prolonged (> 7 days) administration of drugs that must be given intravenously,
- necessity to continue parenteral nutrition along with difficulties to secure peripheral venous access.
Assessment of feedings tolerance will be at discretion of the physician taking care for the infant. After central line removal, infants in group A will continue to receive parenteral nutrition via peripheral venous access at the discretion of the physician taking care for the infant. The solution used to continue parenteral nutrition via peripheral venous access will contain at maximum 2,5% amino acids, 10% glucose and no calcium or phosphate preparations to ensure fluid's osmolality will not exceed 900 mOsm/l and the solution will be well tolerated when administered via peripheral vein.
Parenteral nutrition will be prescribed according to the local protocol. Enteral nutrition will be initiated during the first days of life and advanced gradually at the discretion of the neonatologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth weight ≤ 1500 g (very low birth weight).
- •Birth weight ≥ 3rd percentile at a given gestational age.
- •Central line inserted (PICC or UVC).
- •Oral intake not exceeding 100 ml/kg/d at randomization.
- •Lack of congenital illness or malformation that may affect growth.
- •Signed parental consent.
排除标准
- •Birth weight > 1500 g.
- •Birth weight < 3rd percentile at a given gestational age.
- •The absence of a central line.
- •Oral intake ≥100 ml/kg/d at randomization.
- •Congenital illness or malformation that may affect growth.
- •Lack of informed consent.
- •Participation in other intervention (investigational) trials, that may affect the primary outcome.
结局指标
主要结局
Weight at 36 weeks PMA.
时间窗: 36 weeks PMA.
Difference between the two intervention arms in weight at 36 weeks PMA. Noninferiority would be declared if a mean difference in weight at 36 weeks PMA will be no more than 210 g.
次要结局
- Head circumference at 36 weeks PMA.(36 weeks PMA.)
- Length at 36 weeks PMA.(36 weeks PMA.)
- Number of peripheral intravenous accesses inserted until discontinuation of parenteral nutrition.(Up to 7 days post-intervention.)
- Weight at 18 to 22 months corrected age (CA).(At 18 to 22 months corrected age (CA).)
- Length at 18 to 22 months corrected age (CA).(At 18 to 22 months corrected age (CA))
- Head circumference at 18 to 22 months corrected age (CA).(At 18 to 22 months corrected age (CA).)
- The rate of CLABSI.(From enrollment up to 2 days after central line removal; day of central line removal is considered Day 1.)
- Time to regain birth weight.(Up to 4 weeks.)
- Central line insertion due to feeding intolerance.(Up tp 7 days post-intervention.)
- Length of hospital stay.(Through study completion, an average of 2 years.)