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

Completed · Not applicable

Conditions studied: Extremely Low Birth Weight Infants, Hypernatremia

In brief

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.

Key facts

Study ID

NCT01219179

Run by

Case Western Reserve University

People needed

19

Starts

2010-11-01

Expected to finish

2012-08-01

Last updated by the study team

2013-02-27

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants less than or equal to 1,100 grams birth weight
• Less than or equal to 28 weeks gestational age

You may not qualify if…

• * 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

Where it is running

• University Hospitals Case Medical Center — Cleveland, Ohio, United States

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