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

NCT01219179 | Completed DMC

• 1 other identifier: 05-10-22
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Extremely Low Birth Weight Infants; Hypernatremia

Keywords

Extremely Low Birth Weight Infants; Hypernatremia; Enteral Sterile Water Feeds

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

sterile water

EXPERIMENTAL

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

Other: Sterile water feedings

Interventions

Sterile water feedings OTHER

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.

sterile water

Eligibility Criteria

• Age: 24 Hours - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants less than or equal to 1,100 grams birth weight
• Less than or equal to 28 weeks gestational age

You may not qualify if:

• \* 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

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Hypernatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Donna Dowling, PhD

  Case Western Reserve University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Study Record Dates

• First Submitted: October 12, 2010
• First Posted: October 13, 2010
• Study Start: November 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 27, 2013

Record last verified: 2013-02

Locations

US (1)