Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preterm Infants and Nephrocalcinosis (NC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438267
Recruitment Status : Completed
First Posted : May 8, 2015
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Intermountain Health Care, Inc.
Information provided by (Responsible Party):
University of Utah

Brief 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.


Condition or disease
Prematurity Nephrocalcinosis Hypercalciuria

Layout table for study information
Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis
Study Start Date : April 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Non-NC group
Enrolled subjects who did not have evidence of NC on renal ultrasound
NC group
Enrolled subjects who did have evidence of NC on renal ultrasound



Primary Outcome Measures :
  1. Urinary calcium to creatinine ratio (UCa/Cr) [ Time Frame: 3 months ]
    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.

  2. Urinary crystals [ Time Frame: 3 months ]
    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.


Secondary Outcome Measures :
  1. Serum Vitamin D levels [ Time Frame: 3 months ]
    Serum vitamin D levels will be analyzed and compared in infants with NC against infants without NC (controls).

  2. Vitamin D intake [ Time Frame: 3 months ]
    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).

  3. Calcium intake [ Time Frame: 3 months ]
    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).

  4. Protein intake [ Time Frame: 3 months ]
    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).

  5. Total bone density per DXA [ Time Frame: 3 months ]
    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.

  6. Tibial bone density per tibial ultrasound [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 2 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants admitted to the newborn intensive care unit.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438267


Locations
Layout table for location information
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84157
Sponsors and Collaborators
University of Utah
Intermountain Health Care, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Sabrina Malone-Jenkins, MD University of Utah

Layout table for additonal information
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT02438267     History of Changes
Other Study ID Numbers: 66906
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: March 13, 2017
Last Verified: June 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Nephrocalcinosis
Hypercalciuria
Urological Manifestations
Signs and Symptoms
Kidney Diseases
Urologic Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases