Management of Hyponatremia in Preterm Infants on Diuretics

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. Identifier: NCT00156572
Recruitment Status : Terminated (decreasing rate of enrollment)
First Posted : September 12, 2005
Last Update Posted : December 27, 2007
Information provided by:
The University of Texas Health Science Center, Houston

Brief Summary:
Hydrochlorothiazide and spironolactone are diuretics that are commonly in preterm infants with bronchopulmonary dysplasia (BPD). Hyponatremia (low blood salt) is a common side effect. It is uncertain whether the best way to treat the hyponatremia is by oral salt supplementation or restricting fluid intake. Our hypothesis is that fluid restricted infants will be better able to preserve the beneficial effects of diuretics on the lungs. The study will include very low birth weight infants (VLBW) 400-1500g from Hermann Memorial Children's Hospital NICU or LBJ General Hospital NICU with BPD. They will be enrolled and randomly assigned to either the salt supplementation group or the fluid restriction group once they become hyponatremic (defined as serum Na <130). The study intervention will take place for four weeks. The primary outcome will be assessed by comparing the patient's initial oxygen and breathing machine requirements with those at the end of the four-week study period.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Hyponatremia on Diuretics Procedure: Sodium supplementation Procedure: Fluid restriction Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Management of Hyponatremia in Preterm Infants on Diuretics
Study Start Date : April 2005
Actual Study Completion Date : December 2007

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U.S. FDA Resources

Primary Outcome Measures :
  1. Oxygen and ventilator requirement expressed as RIS

Secondary Outcome Measures :
  1. Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Very low birth weight infants, 400-1500 grams
  2. Bronchopulmonary dysplasia defined by an oxygen requirement greater than 30% at 4 weeks of age and chest x-ray findings consistent with developing chronic lung disease.
  3. Receiving 120kcal/kg/d enterally with fortified human milk or 24 kcal/oz formula
  4. Hyponatremic (defined as serum Na <130).

Exclusion Criteria:

  1. Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
  2. Creatinine ≥ 1.3.
  3. Enteral ostomy.

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 identifier (NCT number): NCT00156572

United States, Texas
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston Identifier: NCT00156572     History of Changes
Other Study ID Numbers: Hyponatremia-Diuretics
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: December 27, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Natriuretic Agents
Physiological Effects of Drugs