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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 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.

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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.

Study Locations (1)

Utah

  • Intermountain Medical Center - Murray

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2015-04
Est. Completion 2017-01

Sponsor

University of Utah

818 total trials

What the Registry Record Tells You About NCT02438267

The ClinicalTrials.gov registry entry for NCT02438267 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 209-participant average among 21 other Prematurity trials with a reported enrollment target (73% lower). The listed sponsor is University of Utah, which has 818 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Prematurity appearing as the primary indexed condition, and to 0 interventions.

NCT02438267 reports 1 study location spanning 1 distinct geographic area - top geographies include 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.

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