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

Overview

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.

Full Title of Study: “The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2012

Interventions

  • 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, Groups and Cohorts

  • Experimental: sterile water
    • Intervention group received sterile water if their sodium value was greater or equal to 150 mEq/liter

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Case Western Reserve University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amy Bieda, Student – Case Western Reserve University
  • Overall Official(s)
    • Donna Dowling, PhD, Study Chair, Case Western Reserve University

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