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Clinical Trials in Italy / NCT06781476
Recruiting Observational

Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants

NCT06781476 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2022-12-07
Last updated
2025-01-17

Condition(s) studied

Kidney Injury

Study summary

The purpose of this study is to define the temporal patterns of urinary biomarkers (CysC, EGF, KIM-1, NGAL, β2-Microglobulin, OPN, and MOD) in the first two weeks of life in preterm and/or very low birth weight (VLBW) infants in relation to the effect of specific factors (hsPDA, prenatal Doppler alterations) and drug therapies. Another objective is then to evaluate the predictivity of these biomarkers with respect to the occurrence of renal damage in preterm infants and possible cut-off values

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Gestational age \<32 weeks or birth weight \<1500 g; * Admission at birth to the Neonatal Intensive Care Unit of the IRCCS A.O.U. of Bologna Policlinico di S. Orsola; * Obtaining informed consent from parents/legal representatives. Exclusion Criteria: * malformations of the urinary system; * major congenital anomalies, including congenital heart disease; * syndromic picture or known genetic abnormalities; * perinatal asphyxia (defined by the finding on arterial blood gas from cord blood of pH≤7.0 or base excess ≤-12 mMol/L and/or Apgar ≤5 or need for resuscitation at 10' of life); * infants who died in the first 48 hours of life or underwent major surgery during the study period.

Primary outcome measure(s)

  • Define the temporal patterns of urinary biomarkers in the first two weeks of life in preterm and/or very low birth weight infants in relation to the effect of specific factors and drug therapies — through study completion, an average of 2 year
    renal function is assessed by concentration of urinary biomarkers

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Bologna Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06781476 on ClinicalTrials.gov ↗ ← All trials in Italy