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

ConditionKidney Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

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 volunteers

Qualifiers

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

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
through study completion, an average of 2 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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