Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Urinary calcium to creatinine ratio (UCa/Cr)
Study Overview
Brief Summary
Nephrocalcinosis (NC), defined as calcification of renal tissue, has been reported to occur in 7-41% of premature infants. Causes of NC are likely multi-factorial, and infants born prematurely and with very low birth weight (<1500 gm) seem to be at the highest risk of developing NC. Recent changes in recommendations for nutrition for the preterm infant such as higher intakes of protein, calcium, and vitamin D may also play a factor in the pathogenesis of NC.
Currently, diagnosis of NC often occurs incidentally during ultrasound evaluation for other issues. Because there is no acute symptom or pattern of symptoms in the preterm population associated specifically with NC, it is possible that many cases of NC may not be diagnosed. Presently, it is impractical and costly to screen all infants for NC with renal ultrasound, therefore there is no standard of care regarding screening for NC.
NC may have long-term effects. Studies have shown that preterm infants with NC had shorter kidneys and a lower rate of tubule resorption of phosphorus (TRP) than preterm infants without NC.
This study will analyze weekly urinalysis for all enrolled subjects prospectively and then look at the incidence of NC at discharge of the enrolled subjects.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 2 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Infants whose gestation less than or equal to 32 weeks and/or birth weights less than 1800 gm
Exclusion Criteria
- •Infants with congenital abnormalities of the heart, lung, GI, or kidneys that will affect renal function.
Outcomes
Primary Outcomes
Urinary calcium to creatinine ratio (UCa/Cr)
Time Frame: 3 months
Beginning within the first two weeks of life, urine calcium to creatinine ratio (UCa/Cr) will be analyzed weekly through discharge and then correlated to renal ultrasound results done prior to discharge.
Urinary crystals
Time Frame: 3 months
Beginning within the first two weeks of life, urinalysis for evidence of urinary crystallization will be analyzed weekly through discharge and then correlated to renal ultrasound results done prior to discharge.
Secondary Outcomes
- Serum Vitamin D levels(3 months)
- Vitamin D intake(3 months)
- Total bone density per DXA(3 months)
- Calcium intake(3 months)
- Protein intake(3 months)
- Tibial bone density per tibial ultrasound(3 months)