Status:
TERMINATED
Management of Hyponatremia in Preterm Infants on Diuretics
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Bronchopulmonary Dysplasia
Hyponatremia on Diuretics
Eligibility:
All Genders
4-6 years
Phase:
PHASE3
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 ...
Detailed Description
Study Question: Among very low birth weight infants, 400-1500 g, with bronchopulmonary dysplasia who develop hyponatremia while receiving hydrochlorothiazide diuretics: does oral sodium supplementati...
Eligibility Criteria
Inclusion
- Very low birth weight infants, 400-1500 grams
- 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.
- Receiving 120kcal/kg/d enterally with fortified human milk or 24 kcal/oz formula
- Hyponatremic (defined as serum Na \<130).
Exclusion
- Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
- Creatinine ≥ 1.3.
- Enteral ostomy.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00156572
Start Date
April 1 2005
End Date
December 1 2007
Last Update
December 27 2007
Active Locations (1)
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1
Memorial Hermann Children's Hospital
Houston, Texas, United States, 77030