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

Completed

• Conditions: Preterm Infant; Nephrocalcinosis

• Registration Number: NCT04382976
• Lead Sponsor: Vilnius University

Brief Summary

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.

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 Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-11
• Primary Completion: 2020-10-01
• Study Completion: 2021-10-01
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2021-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 171

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Compare demographic, clinical, biochemical and treatment results between nephrocalcinosis and the control (without nephrocalcinosis) groups.	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.
To evaluate the dynamics of nephrocalcinosis at 6 and 12 months of corrected age.	6 and 12 months of corrected age	Nephrologist consultation of the infants with nephrocalcinosis at 6 and 12 months of corrected age

Trial Locations

Locations (1)

Vilnius University, Neonatology Centre; 🇱🇹 Vilnius, Lithuania