Preterm Infants and Nephrocalcinosis

Prematurity Clinical Trial

— NC  

Official title:

Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02438267
• Other study ID #: 66906
• Status: Completed
• Phase: N/A
• First received: May 1, 2015
• Last updated: March 9, 2017
• Start date: April 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2016
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Hypercalciuria
• Nephrocalcinosis
• Prematurity

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary calcium to creatinine ratio (UCa/Cr)	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.	3 months
Primary	Urinary crystals	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.	3 months
Secondary	Serum Vitamin D levels	Serum vitamin D levels will be analyzed and compared in infants with NC against infants without NC (controls).	3 months
Secondary	Vitamin D intake	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 months
Secondary	Calcium intake	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).	3 months
Secondary	Protein intake	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).	3 months
Secondary	Total bone density per DXA	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.	3 months
Secondary	Tibial bone density per tibial ultrasound	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.	3 months