Clinical Trials Directory

Trials / Completed

CompletedNCT02438267

Preterm Infants and Nephrocalcinosis

Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis

Status
Completed
Phase
Study type
Observational
Enrollment
56 (actual)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
2 Weeks
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2015-04-01
Primary completion
2017-01-01
Completion
2017-01-01
First posted
2015-05-08
Last updated
2017-03-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02438267. Inclusion in this directory is not an endorsement.