Preterm Infants and Nephrocalcinosis

NCT ID: NCT02438267

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prematurity Nephrocalcinosis Hypercalciuria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Non-NC group

Enrolled subjects who did not have evidence of NC on renal ultrasound

No interventions assigned to this group

NC group

Enrolled subjects who did have evidence of NC on renal ultrasound

No interventions assigned to this group

Eligibility Criteria

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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.
Maximum Eligible Age

2 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intermountain Health Care, Inc.

OTHER

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabrina Malone-Jenkins, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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66906

Identifier Type: -

Identifier Source: org_study_id

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