Determining the Effect of Spironolactone on Electrolyte Supplementation in Preterm Infants With Chronic Lung Disease

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Chronic Lung Disease, Bronchopulmonary Dysplasia

In brief

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.

Key facts

Study ID

NCT01721655

Run by

West Virginia University Healthcare

People needed

40

Starts

2012-10-01

Expected to finish

2016-12-01

Last updated by the study team

2016-11-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• West Virginia University Healthcare — Morgantown, West Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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