Management of Hyponatremia in Preterm Infants on Diuretics
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Enrollment
- 58
- Locations
- 2
- Primary Endpoint
- Oxygen and ventilator requirement expressed as RIS
Study Overview
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.
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 supplementation compared to fluid restriction affect FiO2 requirements (change in Respiratory Index Score [RIS] in Ventilated or CPAP babies, or change in FiO2 in spontaneously breathing babies) after four weeks?
Randomization Method:
Enrolled patients will be randomly assigned to either the sodium supplementation group or the fluid restriction group once they become hyponatremic (serum sodium < 130) while taking hydrochlorothiazide.
Interventions:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Weeks to 6 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
- •Creatinine ≥ 1.
- •Enteral ostomy.
Outcomes
Primary Outcomes
Oxygen and ventilator requirement expressed as RIS
Secondary Outcomes
- Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP