Tracking urinary biomarkers in preterm infants to assess kidney injury
Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants: Influence of Clinical and Therapeutic Factors
This study is testing if tracking certain urine markers in preterm infants can help doctors spot kidney injury early and improve care for these vulnerable babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 78 (estimated) |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06781476 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the trends of specific urinary biomarkers in preterm very low birth weight infants during their first two weeks of life. It focuses on understanding how factors like patent ductus arteriosus and prenatal Doppler alterations, as well as drug therapies, influence these biomarkers. The study seeks to establish predictive values for these biomarkers in relation to kidney injury, which is a common risk in this vulnerable population. By monitoring renal function, the research hopes to identify infants at higher risk for renal damage and tailor clinical approaches accordingly.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born before 32 weeks of gestation or weighing less than 1500 grams who are admitted to the Neonatal Intensive Care Unit.
Not a fit: Patients with urinary system malformations, major congenital anomalies, or those who experience perinatal asphyxia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for kidney injury in preterm infants.
How similar studies have performed: While the approach of monitoring urinary biomarkers in this context is promising, it is not widely established, indicating a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Francesca Vitali, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Francesca Vitali, MD
- Email: francesca.vitali@aosp.bo.it
- Phone: +390512144463
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.