Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Primary Purpose
Extremely Low Birth Weight Infants, Hypernatremia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sterile water feedings
Sponsored by
About this trial
This is an interventional treatment trial for Extremely Low Birth Weight Infants focused on measuring Extremely Low Birth Weight Infants, Hypernatremia, Enteral Sterile Water Feeds
Eligibility Criteria
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
Sites / Locations
- University Hospitals Case Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
sterile water
Arm Description
Intervention group received sterile water if their sodium value was greater or equal to 150 mEq/liter
Outcomes
Primary Outcome Measures
serum sodium values
electrolytes will be measured every 12 hours from admission through the first seven days of life
Secondary Outcome Measures
Full Information
NCT ID
NCT01219179
First Posted
October 12, 2010
Last Updated
February 26, 2013
Sponsor
Case Western Reserve University
1. Study Identification
Unique Protocol Identification Number
NCT01219179
Brief Title
Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Official Title
The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extremely Low Birth Weight Infants, Hypernatremia
Keywords
Extremely Low Birth Weight Infants, Hypernatremia, Enteral Sterile Water Feeds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sterile water
Arm Type
Experimental
Arm Description
Intervention group received sterile water if their sodium value was greater or equal to 150 mEq/liter
Intervention Type
Other
Intervention Name(s)
Sterile water feedings
Intervention Description
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.
Primary Outcome Measure Information:
Title
serum sodium values
Description
electrolytes will be measured every 12 hours from admission through the first seven days of life
Time Frame
Every 12 hours for 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donna Dowling, PhD
Organizational Affiliation
Case Western Reserve University
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Use of Sterile Water Feeds for Treatment of Hypernatremia in Extremely Low Birth Weight Infants
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