Recruiting
Phase 2
Phase 3

Spironolactone

Sponsor:

West Virginia University Healthcare

Code:

NCT01721655

Conditions

Chronic Lung Disease

Bronchopulmonary Dysplasia

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Spironolactone

Placebo

Study Details

Brief summary:

Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major complication of premature birth and is associated with a significant increased risk of complications including death. Diuretics have been used for decades in babies with BPD and are considered a standard of care. Patients receive electrolyte supplementation to replace the electrolytes removed by the diuretics. Spironolactone is not as good as other diuretics at removing extra fluid, but it is different from chlorothiazide and furosemide because instead of removing potassium, it actually can increase potassium levels in our body. Spironolactone is used with chlorothiazide to try to minimize the potassium lost; therefore, reduce the electrolyte supplementation needed. However, studies have suggested that preterm babies aren“t developed enough to appropriately respond to spironolactone. Also, one study has shown that adding spironolactone to chlorothiazide in patients with BPD has no effect on whether or not patients receive electrolyte supplementation. This study will examine whether there is a difference in the amount of electrolyte supplementation between patients receiving chlorothiazide only or chlorothiazide plus spironolactone. the investigators hypothesize there will be no difference in the amount of electrolyte supplementation between the two groups.

Conditions

Chronic Lung Disease

Bronchopulmonary Dysplasia

Study ID

NCT01721655

Start date

Oct, 2012

Status verified date

Nov, 2016

Completion date

Dec, 2016

Anticipated

Primary completion date

Dec, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • The attending makes the decision to start enteral chlorothiazide for long-term diuretic therapy.
  • Gestational age < 32 weeks at time of delivery
  • If patient is currently receiving furosemide and electrolyte supplements, these must be discontinued prior to enrollment.

Exclusion Criteria:

  • Renal anomaly
  • Receiving maintenance IV fluids for more than the previous 48 hours
  • Any contraindication to receiving enteral medication
  • Serum Na < 132 mEq/L
  • Serum K < 3.0 mEq/L
  • Serum Cl < 92 mEq/L
  • Presence of ostomy of any sort

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Spironolactone

Oral spironolactone suspension dosed at 3 mg/kg/day will be administered once-daily to the patients assigned to the treatment arm.

placebo comparator: Placebo suspension

An oral placebo suspension dosed at 3 mg/kg/day administered once-daily will be given to patients in the placebo arm.

Interventions

Spironolactone

Patients will continue to receive standard of care as if they were not enrolled in the study. All patients will receive oral chlorothiazide 40 mg/kg/day divided twice-daily, electrolyte supplementation as needed based on a standard algorithm, and if needed, rescue enteral furosemide 2 mg/kg/day. The intervention will be enteral spironolactone 3 mg/kg once daily

Placebo

Patients will continue to receive standard of care as if they were not enrolled in the study. All patients will receive oral chlorothiazide 40 mg/kg/day divided twice-daily, electrolyte supplementation as needed based on a standard algorithm, and if needed, rescue enteral furosemide 2 mg/kg/day.

Primary outcome measure

  • Dose of potassium chloride in milliequivalents/kg/day [ Time Frame: Day 28 ]

Central Contacts and Locations

Central contacts

Locations

West Virginia University Healthcare

Recruiting

Morgantown, West Virginia, United States, 26505

More Information

Sponsor

West Virginia University Healthcare

Last update posted

Nov 30, 2016

Last verified

Nov, 2016

Keywords

  • Spironolactone
  • Preterm Infants
  • Chronic Lung Disease
  • Bronchopulmonary Dysplasia
  • Electrolyte Supplementation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University Healthcare on 2016-11-30.