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

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

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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant; Nephrocalcinosis

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 171

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08464
    • Vilnius University, Neonatology Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 7 months (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population is a group of very preterm infants less than 32 weeks of gestation during hospitalisation at the Neonatology Centre.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of nephrocalcinosis in very preterm infants less than 32 weeks of gestation	Kidney ultrasound results will divide preterm infants in the group with and without nephrocalcinosis (control).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.	Patients data (demographic, clinical, biochemical and treatment results) collected during hospitalisation at the Neonatology Centre will be compared between nephrocalcinosis and control group.	3 years
To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.	Nephrologist consultation of the infants with nephrocalcinosis at 6 and 12 months of corrected age	6 and 12 months of corrected age

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Principal Investigator: Rasa Garunkstiene, PhD, Vilnius University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2018
• Primary Completion (ACTUAL): October 1, 2020
• Study Completion (ACTUAL): October 1, 2021

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Calcium Metabolism Disorders; Calcinosis; Premature Birth; Nephrocalcinosis
• Other Study ID Numbers: 158200-R-100

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No