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NCT Number: NCT01219179

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

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.

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Key information

Conditions

Extremely Low Birth Weight Infants Hypernatremia Metabolic Diseases Nutritional and Metabolic Diseases Water-Electrolyte Imbalance

Age range

24 hour–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sterile water feedings

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.

Primary outcomes

  1. serum sodium values

    Time frame: Every 12 hours for 7 days

    electrolytes will be measured every 12 hours from admission through the first seven days of life

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 13, 2010
Registry last updated
Feb 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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