We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01219179
First Posted: October 13, 2010
Last Update Posted: February 27, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amy Bieda, Case Western Reserve University
  Purpose

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.


Condition Intervention
Extremely Low Birth Weight Infants Hypernatremia Other: Sterile water feedings

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Enteral Sterile Water Feeds for the Treatment of Hypernatremia in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Amy Bieda, Case Western Reserve University:

Primary Outcome Measures:
  • 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


Enrollment: 19
Study Start Date: November 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sterile water
Intervention group received sterile water if their sodium value was greater or equal to 150 mEq/liter
Other: 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.


  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219179


Locations
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Case Western Reserve University
Investigators
Study Chair: Donna Dowling, PhD Case Western Reserve University
  More Information

Responsible Party: Amy Bieda, Student, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01219179     History of Changes
Other Study ID Numbers: 05-10-22
First Submitted: October 12, 2010
First Posted: October 13, 2010
Last Update Posted: February 27, 2013
Last Verified: February 2013

Keywords provided by Amy Bieda, Case Western Reserve University:
Extremely Low Birth Weight Infants
Hypernatremia
Enteral Sterile Water Feeds

Additional relevant MeSH terms:
Body Weight
Birth Weight
Infertility
Hypernatremia
Signs and Symptoms
Genital Diseases, Male
Genital Diseases, Female
Water-Electrolyte Imbalance
Metabolic Diseases