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

NCT ID: NCT04382976

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2021-10-01

Brief Summary

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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

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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.

Conditions

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Nephrocalcinosis Preterm Infant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

31 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rasa Garunkstiene, PhD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Locations

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Vilnius University, Neonatology Centre

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

Other Identifiers

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158200-R-100

Identifier Type: -

Identifier Source: org_study_id