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

NCT06781476 | Recruiting

• 1 other identifier: NEO-RENE
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Kidney Injury

Keywords

kidney injury; urinary biomarkers; premature newborns

Outcome Measures

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

  through study completion, an average of 2 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Retrospective cohort: number of infants enrolled in the 154/2015/U/Oss protocol. Prospective cohort: 40 patients are expected to be enrolled.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

urinary samples

Study Officials

• Francesca Vitali, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Vitali, MD

CONTACT

+390512144463; francesca.vitali@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 17, 2025
• Study Start: December 7, 2022
• Primary Completion: June 15, 2025
• Study Completion: June 15, 2025
• Last Updated: January 17, 2025

Record last verified: 2024-10

Locations

IT (1)