Actively Recruiting

All Genders
NCT06781476

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

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-17

78

Participants Needed

1

Research Sites

131 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age less than 32 weeks or birth weight less than 1500 grams
  • 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
Not Eligible

You will not qualify if you...

  • Malformations of the urinary system
  • Major congenital anomalies, including congenital heart disease
  • Syndromic conditions or known genetic abnormalities
  • Perinatal asphyxia defined by arterial blood gas pH 7.0 or less, base excess -12 mMol/L or less, Apgar score 5 or less, 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

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

F

Francesca Vitali, MD

CONTACT

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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