Preterm Infants and Nephrocalcinosis

NCT02438267 | Completed

• 1 other identifier: 66906
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity; Nephrocalcinosis; Hypercalciuria

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (6)

• Serum Vitamin D levels

  3 months

• Vitamin D intake

  3 months

• Calcium intake

  3 months

• Protein intake

  3 months

• Total bone density per DXA

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 2 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants admitted to the newborn intensive care unit.

You may qualify if:

• Infants whose gestation less than or equal to 32 weeks and/or birth weights less than 1800 gm

You may not qualify if:

• Infants with congenital abnormalities of the heart, lung, GI, or kidneys that will affect renal function.

Sponsors & Collaborators

• University of Utah: lead
• Intermountain Health Care, Inc.: collaborator

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Premature Birth; Nephrocalcinosis; Hypercalciuria

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Male Urogenital Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sabrina Malone-Jenkins, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2015
• First Posted: May 8, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2016-06

Locations

US (1)