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Completed

NCT Number: NCT02438267

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 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.

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Key information

Conditions

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

Age range

Up to 2 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center

Murray, Utah, 84157, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Intermountain Health Care, Inc.

Registry information

Official study title

Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis

Acronym: NC

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 8, 2015
Registry last updated
Mar 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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