An observational study in Prematurity, Nephrocalcinosis and Hypercalciuria, sponsored by University of Utah. Completed at 1 site in United States. Open to participants aged Up to 2 Weeks. Per ClinicalTrials.gov, last updated 2017-03-13.
Sponsored by University of Utah · Observational
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.
Infants admitted to the newborn intensive care unit.
Exclusion Criteria:
Enrolled subjects who did not have evidence of NC on renal ultrasound
Enrolled subjects who did have evidence of NC on renal ultrasound
Urinary calcium to creatinine ratio (UCa/Cr)
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.
Time frame: 3 months
Urinary crystals
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.
Time frame: 3 months
Serum Vitamin D levels
Serum vitamin D levels will be analyzed and compared in infants with NC against infants without NC (controls).
Time frame: 3 months
Vitamin D intake
Daily vitamin D intake will be recorded from participants' medical records and will be analyzed and compared in infants with NC against infants without NC (controls).
Time frame: 3 months
Calcium intake
Daily calcium intakes will be recorded from participants' medical records and will be analyzed and compared in infants with NC against infants without NC (controls).
Time frame: 3 months
Protein intake
Daily protein intakes will be recorded from participants' medical records and will be analyzed and compared in infants with NC against infants without NC (controls).
Time frame: 3 months
Total bone density per DXA
Whole body bone density per dual energy X-ray absorptiometry (DXA) will be done on all enrolled participants at discharge and will be compared between infants with and without NC.
Time frame: 3 months
Tibial bone density per tibial ultrasound
Tibial body bone density per ultrasound will be done on all enrolled participants at discharge and will be compared between infants with and without NC.
Time frame: 3 months
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Nephrocalcinosis
University of Utah