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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01219179
Study type Interventional
Source Case Western Reserve University
Contact
Status Completed
Phase N/A
Start date November 2010
Completion date August 2012

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