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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04382976

Enrollment

171

Registered

2020-05-11

Start date

2018-10-01

Completion date

2021-10-01

Last updated

2021-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrocalcinosis, Preterm Infant

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 31 Weeks

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Lithuania

Outcome results