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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04382976
• Other study ID #: 158200-R-100
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Nephrocalcinosis
• Premature Birth
• Preterm Infant

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