Management of Hyponatremia in Preterm Infants on Diuretics
关键词
抽象
描述
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.
日期
最后验证: | 11/30/2007 |
首次提交: | 09/06/2005 |
提交的预估入学人数: | 09/06/2005 |
首次发布: | 09/11/2005 |
上次提交的更新: | 12/25/2007 |
最近更新发布: | 12/26/2007 |
实际学习开始日期: | 03/31/2005 |
预计完成日期: | 11/30/2007 |
状况或疾病
干预/治疗
Procedure: Sodium supplementation
Procedure: Fluid restriction
相
资格标准
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | 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. |
结果
主要结果指标
1. Oxygen and ventilator requirement expressed as RIS [undefined]
次要成果指标
1. Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP [undefined]