About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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);
Trial population
Retrospective cohort: number of infants enrolled in the 154/2015/U/Oss protocol. Prospective cohort: 40 patients are expected to be enrolled.
Trial design
Other
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Define the temporal patterns of urinary biomarkers in the first two weeks of life in preterm and/or very low birth weight infants in relation to the effect of specific factors and drug therapies
renal function is assessed by concentration of urinary biomarkers
Sponsors and contacts
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