The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- serum sodium values
研究概览
简要总结
The improved survival rate of extremely low birth weight(ELBW)infants has resulted in new fluid and electrolyte problems that have not been encountered previously,in particular electrolyte imbalance. ELBW infants are especially vulnerable to hypernatremia(serum sodium value >150 mEq/L). Hypernatremia may be due to rapid dehydration or excessive administration of intravenous fluids(IV)that contain sodium. The current treatment modality for hypernatremia is to increase IV fluids above daily requirements.Enteral sterile water feeds(ESWF)are theorized as an endogenous source of fluids that may decrease elevated electrolytes such as sodium and potassium in premature infants. By giving ESWF to decrease elevated electrolytes, there would be less need for large volumes of IVF that contribute to the co-morbidities of prematurity: bronchopulmonary dysplasia (BPD),intraventricular hemorrhage(IVH)and patent ductus arteriosus(PDA).
The purpose of this proposed study is to determine whether enteral sterile water feedings is effective in decreasing the incidence, duration and severity of hypernatremia in ELBW infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Hours 至 28 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants less than or equal to 1,100 grams birth weight
- •Less than or equal to 28 weeks gestational age
排除标准
- •* Congenital heart disease, other than a PDA
- •Major congenital anomalies
- •A surgical condition (gastroschisis,omphalocele)
- •Renal disease
- •Hypotension treated with pressor support
- •Reverse end diastolic flow on Doppler study prior to delivery
- •Emergency medication received in the delivery room,except fluid boluses
- •Apgar scores recorded at 10 minutes of life < or up to 5 and/or pH less than 7.0 on the first blood gas upon admission to the NICU
结局指标
主要结局
serum sodium values
时间窗: Every 12 hours for 7 days
electrolytes will be measured every 12 hours from admission through the first seven days of life
次要结局
未报告次要终点
研究者
Amy Bieda
Student
Case Western Reserve University
