Early Sodium Intake in Preterm Newborns; Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Hyponatremia
研究概览
简要总结
Hyponatremia is a common complication among preterm infants, renal losses of sodium contribute to the development of hyponatremia in preterm newborns. Sodium imbalances impact in newborns outcome. There is controversy about the time of initiation and the requirements of sodium in premature infants. Hypothesis: early (24 hours of life) sodium supplementation (5mEq/kg/day) prevents the develop of hyponatremia in preterm infants.
详细描述
This study is a randomized controlled trial in infants less than 35 weeks gestation admitted to the Newborn Intensive Care Unit at Children Hospital in Saltillo Coahuila Mexico.
Infants receive at 24 hours of life; sodium (5mEq/kg/day) versus less than 1mEq/kg/day. Weight, serum and urine sodium, serum chloride, serum and urine creatinine, serum chloride, bicarbonate and glucose are monitored daily during the first 3 days of life. Patients are assessed for hyponatremia, hypernatremia, weight change, sepsis, necrotizing enterocolitis and intraventricular hemorrhage.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants <35 Weeks gestation
排除标准
- •Urinary malformations
- •Congenital abdominal wall defect
- •Intestinal atresia / obstruction
- •Congenital heart defect
研究组 & 干预措施
Sodium < 1mEq/kg/day
Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life one
干预措施: Sodium < 1mEq/kg/day (Drug)
Sodium 5mEq/kg/day
Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life one
干预措施: Sodium 5mEq/kg/day (Drug)
结局指标
主要结局
Hyponatremia
时间窗: 72 hours
serum sodium \<130mEq/L
Hypernatremia
时间窗: 72 hours
serum sodium \>150mEq/L
次要结局
- Mortality(Patients will be followed during hospitalization, an expected average of 3 months of age)
- % Weight Change(Initial weight (baseline) vs 72 hours)
- Number of Participants With Late-onset Sepsis(Patients will be followed during hospitalization, an expected average of 3 months of age)
- Change in Serum Sodium(Initial serum sodium (baseline) vs 72 hours)
- Number of Participants With Intraventricular Hemorrhage(Patients will be followed during hospitalization, an expected average of 3 months of age)
- Weight Change(Initial weight (baseline) vs 72 hours)
- Number of Participants With Necrotizing Enterocolitis(Patients will be followed during hospitalization, an expected average of 3 months of age)
研究者
csanchezg
Pediatric Nephrology
Hospital del Niño "Dr. Federico Gomez Santos"