Management of Hyponatremia in Preterm Infants on Diuretics
Stopped early · Phase 3
Conditions studied: Bronchopulmonary Dysplasia, Hyponatremia on Diuretics
In brief
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.
Key facts
- Study ID
- NCT00156572
- Run by
- The University of Texas Health Science Center, Houston
- People needed
- 58
- Starts
- 2005-04-01
- Expected to finish
- 2007-12-01
- Last updated by the study team
- 2007-12-27
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
- Creatinine ≥ 1.3.
- Enteral ostomy.
Where it is running
- Memorial Hermann Children's Hospital — Houston, Texas, United States
Full record on ClinicalTrials.gov
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