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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01219179
Enrollment
19
Registered
2010-10-13
Start date
2010-11-30
Completion date
2012-08-31
Last updated
2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Low Birth Weight Infants, Hypernatremia

Keywords

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

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.

Interventions

OTHERSterile 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.

Sponsors

Case Western Reserve University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
24 Hours to 28 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
serum sodium valuesEvery 12 hours for 7 dayselectrolytes will be measured every 12 hours from admission through the first seven days of life

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026