Bronchopulmonary DysplasiaPhase 3NCT00156572
Management of Hyponatremia in Preterm Infants on Diuretics
A Phase 3 study testing Sodium supplementation and Fluid restriction in people with Bronchopulmonary Dysplasia and Hyponatremia on Diuretics, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 weeks to 6 months
- Conditions the study is for
- Bronchopulmonary Dysplasia, Hyponatremia on Diuretics
- What is being tested?
- Sodium supplementation and Fluid restriction
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 weeks to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Very low birth weight infants, 400-1500 grams
- 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.
- Receiving 120kcal/kg/d enterally with fortified human milk or 24 kcal/oz formula
- Hyponatremic (defined as serum Na <130).
Who cannot join
- Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
- Creatinine ≥ 1.3.
- Enteral ostomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Hermann Children's Hospital
Houston, Texas, 77030
About this study
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.
Read the 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
- 24-hour urine sodium, calcium, and creatinine at 4 weeks.
- The mean serum Na+ nadir for each group.
- The mean serum K+ nadir for each group.
- Time to extubation for infants ventilated at enrollment.
- 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.
- Being tested
- Sodium supplementation, Fluid restriction
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium supplementationProcedure or surgery
Fluid restrictionProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen and ventilator requirement expressed as RIS
Secondary outcomes (1)
Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2005
- Study completionDec 2007
Why it stopped: decreasing rate of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- Kathleen A Kennedy, MD, MPH, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156572
- Sponsor's protocol ID
- Hyponatremia-Diuretics
- Status last verified
- Dec 2007
- First submitted
- 7 Sep 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hyponatremia in Preterm Infants on Diuretics
- ClinicalTrials.gov ID
- NCT00156572
- Acronym / sponsor ID
- Hyponatremia-Diuretics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: decreasing rate of enrollment
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Dec 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 24-hour urine sodium, calcium, and creatinine at 4 weeks.
- The mean serum Na+ nadir for each group.
- The mean serum K+ nadir for each group.
- Time to extubation for infants ventilated at enrollment.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 4 weeks to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Very low birth weight infants, 400-1500 grams
- 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.
- Receiving 120kcal/kg/d enterally with fortified human milk or 24 kcal/oz formula
- Hyponatremic (defined as serum Na <130).
Key exclusion criteria (3 listed)
- Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
- Creatinine ≥ 1.3.
- Enteral ostomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium supplementation | Procedure or surgery | – |
| Fluid restriction | Procedure or surgery | – |
Primary outcome
Oxygen and ventilator requirement expressed as RIS
1 secondary outcome
Urine sodium, calcium, creatinine, serum Na nadir, serum K nadir, duration of mechanical ventilation, duration of CPAP
Results and safety
The study was stopped early (reason given: decreasing rate of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2007.
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BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen A Kennedy, MD, MPH principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium supplementation and Fluid restriction in people with Bronchopulmonary Dysplasia and Hyponatremia on Diuretics, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: decreasing rate of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen and ventilator requirement expressed as RIS. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2007.