NCT06781476 Evaluation of Urinary Biomarkers Trend in Preterm Very Low Birth Weight Infants
| NCT ID | NCT06781476 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 78 participants |
| Start Date | 2022-12-07 |
| Primary Completion | 2025-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 78 participants in total. It began in 2022-12-07 with a primary completion date of 2025-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Francesca Vitali, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06781476 clinical trial?
This trial is open to participants of all sexes, studying Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06781476 currently recruiting?
Yes, NCT06781476 is actively recruiting participants. Contact the research team at francesca.vitali@aosp.bo.it for enrollment information.
Where is the NCT06781476 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06781476 clinical trial?
NCT06781476 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Francesca Vitali, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 78 participants.
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