Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156572
Status:
TERMINATED
Last Update Posted:
2007-12-27
First Post:
2005-09-07
Brief Title:
Management of Hyponatremia in Preterm Infants on Diuretics
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Management of Hyponatremia in Preterm Infants on Diuretics
Status:
TERMINATED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
decreasing rate of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Childrens 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 patients 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 meqkgday of NaCl added to their feeds If the serum sodium is 120-124 they will have 4 meqkgday 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 20cckgday In order to maintain approximately the same caloric intake 05 cckgdose of corn oil 84kcalcc will be administered as a bolus every 6 hours If this fluid restriction doesnt 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 cckgd the fluid intake will be decreased by an additional 10cckgday for one additional week
Outcome Assessments Primary Outcome - the change in FiO2RIS 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 01 x 40 4 absolute difference expected standard deviation of 5 for FiO2 alpha two-sided 005 Beta 1 - 080 020
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
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 meqkgday of NaCl added to their feeds If the serum sodium is 120-124 they will have 4 meqkgday 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 20cckgday In order to maintain approximately the same caloric intake 05 cckgdose of corn oil 84kcalcc will be administered as a bolus every 6 hours If this fluid restriction doesnt 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 cckgd the fluid intake will be decreased by an additional 10cckgday for one additional week
Outcome Assessments Primary Outcome - the change in FiO2RIS 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 01 x 40 4 absolute difference expected standard deviation of 5 for FiO2 alpha two-sided 005 Beta 1 - 080 020
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None