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NCT02438267 · ClinicalTrials.gov registry record
Preterm Infants and Nephrocalcinosis
A clinical trial of Prematurity and Hypercalciuria, sponsored by University of Utah.
- Completed
- Registry status
- 56
- Enrollment target
- 1
- Study location
NCT02438267: Completed study of Prematurity and Hypercalciuria, sponsored by University of Utah.
NCT02438267 is a study of Prematurity and Hypercalciuria that has completed, run by University of Utah. The registered enrollment target is 56 participants, below the 209-participant average among 21 other Prematurity trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02438267, a study of Prematurity and Hypercalciuria, has completed, sponsored by University of Utah.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (1)
Utah
- Intermountain Medical Center - Murray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2015-04 |
| Est. Completion | 2017-01 |
What the finished NCT02438267 record still lists
NCT02438267 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 209-participant average among 21 other Prematurity trials with a reported enrollment target (73% lower).
The record links to 3 conditions, with Prematurity appearing as the primary indexed condition, and to 0 interventions.
NCT02438267 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT02438267 about?
NCT02438267 is a clinical study titled "Preterm Infants and Nephrocalcinosis". 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 ...
What is the current status of trial NCT02438267?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2015-04. Estimated completion is 2017-01.
What conditions does trial NCT02438267 study?
This clinical trial studies the following conditions: Prematurity, Hypercalciuria, Nephrocalcinosis.
Who is sponsoring clinical trial NCT02438267?
This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02438267 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prematurity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02438267's enrollment target sits among peer trials
56 18th of 21 higher than 4 of 21 other Prematurity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prematurity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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