Management of Hyponatremia in Preterm Infants on Diuretics

This study has been terminated.
(decreasing rate of enrollment)
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00156572
First received: September 7, 2005
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Bronchopulmonary Dysplasia
Hyponatremia on Diuretics
Procedure: Sodium supplementation
Procedure: Fluid restriction
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Management of Hyponatremia in Preterm Infants on Diuretics

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Oxygen and ventilator requirement expressed as RIS

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

Estimated Enrollment: 58
Study Start Date: April 2005
Study Completion Date: December 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156572

Locations
United States, Texas
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00156572     History of Changes
Other Study ID Numbers: Hyponatremia-Diuretics
Study First Received: September 7, 2005
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014