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

Not Applicable

Completed

• Conditions: Extremely Low Birth Weight Infants; Hypernatremia
• Interventions: Other: Sterile water feedings

• Registration Number: NCT01219179
• Lead Sponsor: Case Western Reserve University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Study First Posted: 2010-10-13
• Study Start: 2010-11
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-26
• Last Update Posted: 2013-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
serum sodium values	Every 12 hours for 7 days	electrolytes will be measured every 12 hours from admission through the first seven days of life

Trial Locations

Locations (1)

University Hospitals Case Medical Center; 🇺🇸 Cleveland, Ohio, United States