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临床试验/NCT01219179
NCT01219179已完成不适用

The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2010年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amy Bieda

Student

Case Western Reserve University

研究点 (2)

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