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

Case Western Reserve University

Status: Completed

Conditions: Hypernatremia; Extremely Low Birth Weight Infants

Treatments: Other: Sterile water feedings

Study type: Interventional

Funder types: Other

Identifiers

NCT01219179

05-10-22

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 24 hours to 28 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

sterile water

Experimental group

Description:

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

Treatment:

Other: Sterile water feedings