An interventional study of Sterile water feedings in Extremely Low Birth Weight Infants and Hypernatremia, sponsored by Case Western Reserve University. Completed at 1 site in United States. Open to participants aged 24 Hours to 28 Weeks. Per ClinicalTrials.gov, last updated 2013-02-27.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Treatment
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.
49 studies on the registry are indexed under Hypernatremia; 8 are open to participants now.
This study's enrollment of 19 is below the median of 64 across 32 interventional studies indexed under Hypernatremia.
Browse Hypernatremia studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Exclusion Criteria:
* Congenital heart disease, other than a PDA
Intervention group received sterile water if their sodium value was greater or equal to 150 mEq/liter
Other: Sterile water feedings
Control group- no intervention Prophylactic group will receive sterile water feeds starting at 24 hours of life if/or when their serum sodium value is ≥ 145 mEq/L. The volume of sterile water is 10mls/Kg/day based on birth weight, given via continuous infusion feed. The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L. The hypernatremia group will receive sterile water feeds when their serum sodium value is ≥ 150 meq/L. The volume of sterile water is 10 mls/Kg/day based on birth weight,given via continuous infusion feed. The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L.
serum sodium values
electrolytes will be measured every 12 hours from admission through the first seven days of life
Time frame: Every 12 hours for 7 days
The record gives a start of Nov 2010, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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