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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypernatremia; Extremely Low Birth Weight Infants
• Intervention / Treatment: Other: Sterile water feedings

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum sodium values	electrolytes will be measured every 12 hours from admission through the first seven days of life	Every 12 hours for 7 days

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Study Chair: Donna Dowling, PhD, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 12, 2010
• First Posted (Estimate): October 13, 2010

Study Record Updates

• Last Update Posted (Estimate): February 27, 2013
• Last Update Submitted That Met QC Criteria: February 26, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Hypernatremia; Extremely Low Birth Weight Infants; Enteral Sterile Water Feeds
• Additional Relevant MeSH Terms: Metabolic Diseases; Water-Electrolyte Imbalance; Infertility; Body Weight; Birth Weight; Hypernatremia
• Other Study ID Numbers: 05-10-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No