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

NCT ID: NCT01219179

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

sterile water

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

Group Type: EXPERIMENTAL

Sterile water feedings

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 28 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Amy Bieda

Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Donna Dowling, PhD

Role: STUDY_CHAIR

Case Western Reserve University

Locations

University Hospitals Case Medical Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

05-10-22

Identifier Type: -

Identifier Source: org_study_id