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Preterm Infants and Nephrocalcinosis

Preterm Infants and Nephrocalcinosis: Diagnosis and Pathogenesis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02438267
Acronym
NC
Enrollment
56
Registered
2015-05-08
Start date
2015-04-30
Completion date
2017-01-31
Last updated
2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercalciuria, Nephrocalcinosis, Prematurity

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.

Interventions

None listed

Sponsors

Intermountain Health Care, Inc.
CollaboratorOTHER
University of Utah
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Urinary calcium to creatinine ratio (UCa/Cr)3 monthsBeginning 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.
Urinary crystals3 monthsBeginning 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

MeasureTime frameDescription
Calcium intake3 monthsDaily calcium intakes will be recorded from participants' medical records and will be analyzed and compared in infants with NC against infants without NC (controls).
Protein intake3 monthsDaily protein intakes will be recorded from participants' medical records and will be analyzed and compared in infants with NC against infants without NC (controls).
Serum Vitamin D levels3 monthsSerum vitamin D levels will be analyzed and compared in infants with NC against infants without NC (controls).
Tibial bone density per tibial ultrasound3 monthsTibial body bone density per ultrasound will be done on all enrolled participants at discharge and will be compared between infants with and without NC.
Total bone density per DXA3 monthsWhole 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.
Vitamin D intake3 monthsDaily 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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026