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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      Bronchopulmonary dysplasia (BPD), also known as chronic lung disease (CLD), is a major
      complication of premature birth and is associated with significant morbidity and mortality.
      Bronchopulmonary dysplasia most commonly affects preterm infants who have required prolonged
      aggressive mechanical ventilation and/or oxygen supplementation. Risk factors associated with
      BPD include degree of prematurity, infection, mechanical ventilation, oxygen concentration,
      and nutritional status. Despite significant advances in the care of preterm infants and
      improved survival, the incidence of BPD has been fairly static over the past decade.

      Diuretics and fluid restriction are considered a mainstay of therapy in the management of BPD
      to combat interstitial alveolar edema. Short courses of furosemide followed by long-term
      therapy using a thiazide diuretic with concurrent spironolactone have shown improvement in
      pulmonary function and better outcomes. Double-blinded, randomized, placebo-controlled trials
      have shown improvement in pulmonary compliance, airway resistance, infants alive at
      discharge, and a decrease in fraction of inspired oxygen and need for furosemide boluses.

      Spironolactone is a competitive aldosterone receptor antagonist that acts on the distal
      convoluted tubule and collecting duct to facilitate sodium excretion while conserving
      potassium and hydrogen ions. Since only a minimal amount of sodium filtered by the glomerulus
      reaches the distal tubule, spironolactone is considered a weak diuretic. Spironolactone is
      primarily used with chlorothiazide for its potassium-sparing effect to reduce the need for
      electrolyte supplementation. There has only been one prospective, randomized, double-blind,
      placebo-controlled study comparing chlorothiazide with or without the addition of
      spironolactone in premature infants with chronic lung disease. This study demonstrated no
      difference between the groups in the need for electrolyte supplementation, electrolyte
      balance, or pulmonary function. In addition, preterm infants' distal tubules may respond
      inadequately to aldosterone; thereby, limiting the role of spironolactone in this patient
      population.

      In the neonatal population, spironolactone is primarily used in addition with chlorothiazide
      for its potassium-sparing effects to reduce the need for electrolyte supplementation.
      However, evidence and current practice suggests the majority of patients still receive
      electrolyte supplementation. One study evaluated spironolactone's effect on the need for
      electrolyte supplementation, but there is no published data with a primary outcome evaluating
      spironolactone's effect on the quantity of electrolyte supplementation. We hypothesize there
      will be no difference in the amount of electrolyte supplementation between the two groups.
    

Study Phase

Phase 2/Phase 3

Study Type

Interventional


Primary Outcome

Dose of potassium chloride in milliequivalents/kg/day

Secondary Outcome

 Requirement of electrolyte supplementation

Condition

Chronic Lung Disease

Intervention

Spironolactone

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

October 2012

Completion Date

December 2016

Primary Completion Date

December 2016

Eligibility Criteria

        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
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Courtney B Sweet, PharmD, 304-598-4148, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01721655

Organization ID

H-24305


Responsible Party

Principal Investigator

Study Sponsor

West Virginia University Healthcare


Study Sponsor

Courtney B Sweet, PharmD, Principal Investigator, WVU Healthcare


Verification Date

November 2016