Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
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|ClinicalTrials.gov Identifier: NCT01219179|
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : February 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Extremely Low Birth Weight Infants Hypernatremia||Other: Sterile water feedings||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: sterile water
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 [ Time Frame: Every 12 hours for 7 days ]electrolytes will be measured every 12 hours from admission through the first seven days of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219179
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Study Chair:||Donna Dowling, PhD||Case Western Reserve University|