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

Launched by IRCCS AZIENDA OSPEDALIERO-UNIVERSITARIA DI BOLOGNA · Jan 13, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how certain substances, called urinary biomarkers, change in preterm infants who are very low birth weight (weighing less than 1500 grams) during their first two weeks of life. These biomarkers can help doctors understand if a baby is at risk for kidney injury and how factors like heart conditions or certain medications might affect them. The study aims to identify patterns in these biomarkers and determine specific levels that could indicate kidney damage.

To participate in this study, infants must be born before 32 weeks of pregnancy or weigh less than 1500 grams and be admitted to a special care unit right after birth. It's important that parents or legal guardians give their permission for their baby to join the trial. Unfortunately, babies with certain health issues or serious medical conditions, such as major birth defects or severe oxygen deprivation at birth, cannot take part. Families involved in the study can expect close monitoring of their baby's health and urine samples will be collected to analyze the biomarkers over time. This research could provide valuable insights into preventing kidney problems in very premature infants.

Gender

ALL

Eligibility 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.