Effect of prophylactic supplementation of sodium on prevention of late onset hyponatremia in neonates less than 32 weeks - A double blinded placebo randomised control trial
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Dr Amrutha Visalakshi S
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo
概览
简要总结
EFFECT OF PROPHYLACTIC SUPPLEMENTATION OF SODIUM ON PREVENTION OF LATE ONSET HYPONATREMIA IN NEONATES <32 WEEKS: A DOUBLE BLINDED PLACEBO RANDOMISED CONTROLLED TRIAL
Purpose of the study
Preterm infants have increased sodium intake requirements due to renal tubular immaturity and its deficiency is associated with significant morbidity. Currently there are no standard of care guidelines regarding how much and how long to supplement sodium in preterm infants to prevent late onset hyponatremia and thereby postnatal growth failure which is directly linked to the long-term neurodevelopmental outcome in this vulnerable population. Knowledge regarding the adverse events related to prophylactic supplementation of sodium is also limited. Good quality studies are lacking regarding sodium supplementation in prevention of late onset hyponatremia.
Hypothesis of the trial
Prophylactic sodium supplementation in extreme and very preterm babies (< 32 weeks) decreases the incidence of late onset hyponatremia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 4.00 Day(s) 至 7.00 Day(s)（—）
- 性别
- All
入选标准
- •Preterm Neonates less than 32 weeks of gestation admitted within 7 days of life at NICU of ABVIMS and Dr. RML Hospital, New Delhi with Serum sodium 130-145 mEq/L by postnatal day 4.
排除标准
- •Presence of lethal congenital malformations or chromosomal abnormalities Presence of AKI (defined as an S.
- •Creatinine rise more than or equal to0.3 mg/dl within 48 h or urine output less than 0.5 (ml/kg/h) for 6–12 h) Disease states (such as hydrops fetalis) that are characterized by edema- like hydrops fetalis, congestive heart failure within DOL 7 Refusal to consent.
结局指标
主要结局
incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo
时间窗: incidence of late onset hyponatremia among neonates less than 32 weeks given prophylactic sodium supplementation versus placebo
次要结局
- 1. To study the effect of prophylactic sodium supplementation in preterm neonates less than 32 weeks on their postnatal weight gain, length & head circumference weekly till discharge(2. To study the effect of sodium supplementation on the incidence of adverse effects like feed intolerance, hypernatremia, reopening of patent ductus arteriosus (PDA) during study period till discharge)
研究者
Dr Amrutha Visalakshi S
ABVIMS and RML hospital ,New Delhi