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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT01219179

Public ClinicalTrials.gov record NCT01219179. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 7, 2026, 11:40 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01219179
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
19 participants

Conditions and interventions

Eligibility (public fields only)

Age range
24 Hours to 28 Weeks
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2010
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012
Last update posted
Feb 26, 2013

2010 – 2012

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University Hospitals Case Medical Center Cleveland Ohio 44106

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01219179, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Feb 26, 2013 · Synced Sep 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01219179 live on ClinicalTrials.gov.

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