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

Hypernatremia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219179
• Other study ID #: 05-10-22
• Status: Completed
• Phase: N/A
• First received: October 12, 2010
• Last updated: February 26, 2013
• Start date: November 2010
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 28 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Extremely Low Birth Weight Infants
• Hypernatremia

Intervention

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.

Locations

Country	Name	City	State
United States	University Hospitals Case Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No