Expired Study
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Cleveland, Ohio 44106


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.


Inclusion Criteria: - Infants less than or equal to 1,100 grams birth weight - Less than or equal to 28 weeks gestational age Exclusion Criteria: - * 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



Primary Contact:

Study Chair
Donna Dowling, PhD
Case Western Reserve University

Backup Contact:


Location Contact:

Cleveland, Ohio 44106
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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