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NCT00156572 · ClinicalTrials.gov registry record · Phase 3
Management of Hyponatremia in Preterm Infants on Diuretics
A Phase 3 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 3
- Development phase
- 58
- Enrollment target
NCT00156572 is a Phase 3 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 58 participants.
The verdict
NCT00156572, a Phase 3 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 58 participants
- Enrollment target
Study 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.
Interventions
- PROCEDURE Sodium supplementation
- PROCEDURE Fluid restriction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2005-04 |
| Est. Completion | 2007-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00156572
The ClinicalTrials.gov registry entry for NCT00156572 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sodium supplementation is the first listed.
NCT00156572 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00156572 about?
NCT00156572 is a clinical study titled "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 ...
What is the current status of trial NCT00156572?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 58 participants. The study started on 2005-04. Estimated completion is 2007-12.
What interventions are being tested in trial NCT00156572?
The interventions under investigation include: Sodium supplementation (PROCEDURE), Fluid restriction (PROCEDURE).
Who is sponsoring clinical trial NCT00156572?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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