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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04382976
Other study ID # 158200-R-100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date October 1, 2021

Study information

Verified date December 2021
Source Vilnius University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date October 1, 2021
Est. primary completion date October 1, 2020
Accepts healthy volunteers No
Gender All
Age group 23 Weeks to 31 Weeks
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Lithuania Vilnius University, Neonatology Centre Vilnius

Sponsors (1)

Lead Sponsor Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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