Management of Hyponatremia in Preterm Infants on Diuretics

NCT00156572 | Terminated Phase 3

• 1 other identifier: Hyponatremia-Diuretics
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bronchopulmonary Dysplasia; Hyponatremia on Diuretics

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Sodium supplementation PROCEDURE

Fluid restriction PROCEDURE

Eligibility Criteria

• Age: 4 Weeks - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• Known congenital anomalies involving the heart, lungs, kidneys, or chromosomal abnormalities.
• Creatinine ≥ 1.3.
• Enteral ostomy.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Children's Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Kathleen A Kennedy, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: April 1, 2005
• Study Completion: December 1, 2007
• Last Updated: December 27, 2007

Record last verified: 2007-12

Locations

US (1)