Management of Hyponatremia in Preterm Infants on Diuretics
|First Received Date ICMJE||September 7, 2005|
|Last Updated Date||December 26, 2007|
|Start Date ICMJE||April 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Oxygen and ventilator requirement expressed as RIS|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00156572 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Management of Hyponatremia in Preterm Infants on Diuretics|
|Official Title ICMJE||Management of Hyponatremia in Preterm Infants on Diuretics|
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.
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?
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.
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.
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.
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 Type ICMJE||Interventional|
|Study Phase||Phase 3|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Terminated|
|Estimated Enrollment ICMJE||58|
|Completion Date||December 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||up to 6 Months|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00156572|
|Other Study ID Numbers ICMJE||Hyponatremia-Diuretics|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||The University of Texas Health Science Center, Houston|
|Collaborators ICMJE||Not Provided|
|Information Provided By||The University of Texas Health Science Center, Houston|
|Verification Date||December 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP