RecruitingNCT06781476

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

Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants: Influence of Clinical and Therapeutic Factors


Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Enrollment

78 participants

Start Date

Dec 7, 2022

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria3

  • 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 Criteria5

  • 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.

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Locations(1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy

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NCT06781476


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