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
Verified date | December 2021 |
Source | Vilnius University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Lithuania | Vilnius University, Neonatology Centre | Vilnius |
Lead Sponsor | Collaborator |
---|---|
Vilnius University |
Lithuania,
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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