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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Amy Bieda, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT01219179

First received: October 12, 2010

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Purpose

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	Intervention
Extremely Low Birth Weight Infants Hypernatremia	Other: Sterile water feedings

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Drinking Water

U.S. FDA Resources

Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:

serum sodium values [ Time Frame: Every 12 hours for 7 days ] [ Designated as safety issue: No ]
electrolytes will be measured every 12 hours from admission through the first seven days of life

Enrollment:	19
Study Start Date:	November 2010
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	up to 28 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219179

Locations

United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

Case Western Reserve University

Investigators

Study Chair:

Donna Dowling, PhD

Case Western Reserve University

More Information

No publications provided

Responsible Party:	Amy Bieda, Student, Case Western Reserve University
ClinicalTrials.gov Identifier:	NCT01219179 History of Changes
Other Study ID Numbers:	05-10-22
Study First Received:	October 12, 2010
Last Updated:	February 26, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Case Western Reserve University:

Extremely Low Birth Weight Infants
Hypernatremia
Enteral Sterile Water Feeds

Additional relevant MeSH terms:

Birth Weight
Hypernatremia
Body Weight

Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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