Actively Recruiting
Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants: Influence of Clinical and Therapeutic Factors
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-17
78
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the patterns of specific urinary biomarkers in the first two weeks of life in premature and very low birth weight infants. The study aims to understand how factors like patent ductus arteriosus, prenatal blood flow changes, and drug treatments affect these biomarkers. It also seeks to evaluate how well these biomarkers predict kidney damage in this vulnerable group and to establish possible cut-off values for clinical use. The study does not involve any drugs or treatments but focuses on observing and measuring biomarkers such as Cystatin C, epithelial growth factor, NGAL, beta-2 Microglobulin, Osteopontin, kidney injury molecule 1, and modulin in urine samples. These biomarkers can be collected noninvasively and repeatedly without requiring blood draws. The goal is to improve early detection and monitoring of kidney function in preterm infants, who are at risk of acute kidney injury due to various clinical factors. Participants will be monitored in the neonatal intensive care unit after birth, with urine samples collected during the first two weeks of life. Researchers will analyze these samples alongside clinical information, including prenatal Doppler flow and drug exposures. The main outcome is the timing and pattern of these urinary biomarkers, tracked over an average of two years. This long-term observation helps assess how early kidney markers relate to later kidney health and potential damage in premature infants.
CONDITIONS
Brief Title
Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 or legal representatives
You will not qualify if you...
- Malformations of the urinary system
- Major congenital anomalies, including congenital heart disease
- Syndromic picture or known genetic abnormalities
- Perinatal asphyxia defined by cord blood arterial pH ≤7.0 or base excess ≤-12 mMol/L and/or Apgar score ≤5 or need for resuscitation at 10 minutes of life
- Infants who died within the first 48 hours of life or underwent major surgery during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants who undergo routine care are observed with serial assessments of urinary biomarkers to evaluate kidney function over time.
Multiple assessments during the first two weeks of life and follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
F
Francesca Vitali, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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