Management of Hyponatremia in Preterm Infants on Diuretics

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Brief Title

Management of Hyponatremia in Preterm Infants on Diuretics

Official Title

Management of Hyponatremia in Preterm Infants on Diuretics

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:

      Sodium Supplementation: Patients randomized to the sodium supplementation group will receive
      oral NaCl added to their feeds. When the serum sodium is 125-130, they will have 2 meq/kg/day
      of NaCl added to their feeds. If the serum sodium is 120-124, they will have 4 meq/kg/day of
      NaCl added to their feeds. Na supplementation will continue until the serum Na is >135.

      Fluid Restriction: Patients randomized to the fluid restriction group will have fluid intake
      decreased by 20cc/kg/day. In order to maintain approximately the same caloric intake, 0.5
      cc/kg/dose of corn oil (8.4kcal/cc), will be administered as a bolus every 6 hours. If this
      fluid restriction doesn't increase the serum sodium to above 130 within one week or if the
      serum Na is 120-124 and if the infant is receiving > 140 cc/kg/d, the fluid intake will be
      decreased by an additional 10cc/kg/day for one additional week.

      Outcome Assessments Primary Outcome - the change in FiO2/RIS between baseline and outcome at
      4 weeks after enrollment.

      Secondary Outcomes

        1. 24-hour urine sodium, calcium, and creatinine at 4 weeks.

        2. The mean serum Na+ nadir for each group.

        3. The mean serum K+ nadir for each group.

        4. Time to extubation for infants ventilated at enrollment.

        5. Time on CPAP or mechanical ventilation for infants on CPAP at enrollment.

      Sample Size:

      The estimated sample size for the study will be 58, based on an effect size of 10% if the
      mean FiO2 is 40% (0.1 x 40= 4% absolute difference), expected standard deviation of 5% for
      FiO2, alpha (two-sided) = 0.05; Beta = 1 - 0.80 = 0.20.

      Analysis:

      The following analysis plan has been designed to allow every randomized infant to be included
      in the analysis (intention-to-treat analysis) regardless of whether they are intubated,
      extubated, taken off or put onto CPAP, or if they die during the course of the 4-week study
      period. All infants (both study groups combined) will be assigned a rank at baseline and at
      outcome (4 weeks) within each of the following subgroups: infants on O2 by oxyhood, infants
      on nasal cannula, infants on CPAP, infants on the ventilator, infants who die during the
      study. For each infant, a change in rank (outcome minus baseline) will be calculated. The
      change in rank will be compared between the two study groups using a non-parametric test.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Oxygen and ventilator requirement expressed as RIS

Secondary Outcome

 Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP

Condition

Bronchopulmonary Dysplasia

Intervention

Sodium supplementation


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

Procedure

Estimated Enrollment

58

Start Date

April 2005

Completion Date

December 2007


Eligibility Criteria

        Inclusion Criteria:

          1. Very low birth weight infants, 400-1500 grams

          2. 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.

          3. Receiving 120kcal/kg/d enterally with fortified human milk or 24 kcal/oz formula

          4. Hyponatremic (defined as serum Na <130).

        Exclusion Criteria:

          1. Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal
             abnormalities.

          2. Creatinine ≥ 1.3.

          3. Enteral ostomy.
      

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

Kathleen A Kennedy, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00156572

Organization ID

Hyponatremia-Diuretics



Study Sponsor

The University of Texas Health Science Center, Houston


Study Sponsor

Kathleen A Kennedy, MD, MPH, Principal Investigator, The University of Texas Health Science Center, Houston


Verification Date

December 2007