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NCT Number: NCT04382976

The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants

The study aims to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants using patient data collected during hospitalisation at the Neonatology Centre.

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Key information

Conditions

Nephrocalcinosis Calcinosis Calcium Metabolism Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Urogenital Diseases Urologic Diseases

Age range

23 week–31 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Vilnius University, Neonatology Centre

Vilnius, 08464, Lithuania

About this study

Nephrocalcinosis in preterm infants develops as a result of imbalance between the factors promoting or inhibiting formation of kidney stones. It is caused by intensive treatment as well as functional and morphological kidney immaturity. There is a correlation between the prevalence of nephrocalcinosis and low gestational age.

The study aims prospectively to assess the incidence and the risk factors of nephrocalcinosis in very preterm infants less than 32 weeks of gestation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • preterm infants of the gestational age of <32 weeks;
  • parental consent acquired.

Exclusion criteria

  • death before 28 days of age;
  • congenital defects;
  • no kidney ultrasound results;
  • no parental consent.

Treatment and study plan

Primary outcomes

  1. The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation

    Time frame: 3 years

    Kidney ultrasound results will divide preterm infants in the group with and without nephrocalcinosis (control).

Secondary outcomes

  1. Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.

    Time frame: 3 years

    Patients data (demographic, clinical, biochemical and treatment results) collected during hospitalisation at the Neonatology Centre will be compared between nephrocalcinosis and control group.

  2. To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.

    Time frame: 6 and 12 months of corrected age

    Nephrologist consultation of the infants with nephrocalcinosis at 6 and 12 months of corrected age

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Registry information

Official study title

The Incidence and the Risk Factors of Nephrocalcinosis in Very Preterm Infants at the Neonatology Centre of Vilnius University Hospital Santaros Klinikos

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
May 11, 2020
Registry last updated
Dec 23, 2021

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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