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| Sponsor: | The University of Texas Health Science Center, Houston |
|---|---|
| Information provided by: | The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT00156572 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bronchopulmonary Dysplasia Hyponatremia on Diuretics |
Procedure: Sodium supplementation Procedure: Fluid restriction |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Management of Hyponatremia in Preterm Infants on Diuretics |
| Estimated Enrollment: | 58 |
| Study Start Date: | April 2005 |
| Study Completion Date: | December 2007 |
Show Detailed Description
Eligibility| Ages Eligible for Study: | up to 6 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| Memorial Hermann Children's Hospital | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Kathleen A Kennedy, MD, MPH | The University of Texas Health Science Center, Houston |
More Information
| ClinicalTrials.gov Identifier: | NCT00156572 History of Changes |
| Other Study ID Numbers: | Hyponatremia-Diuretics |
| Study First Received: | September 7, 2005 |
| Last Updated: | December 26, 2007 |
| Health Authority: | United States: Institutional Review Board |
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Bronchopulmonary Dysplasia Hyponatremia Ventilator-Induced Lung Injury Lung Injury Lung Diseases Respiratory Tract Diseases Infant, Premature, Diseases |
Infant, Newborn, Diseases Water-Electrolyte Imbalance Metabolic Diseases Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions |