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Kidney InjuryNCT06781476

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

An observational study of Kidney Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Kidney Injury
How many people
78 participants
Where
1 siteItaly
Study dates
7 Dec 2022to 15 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Francesca Vitali, MD contact

+390512144463

francesca.vitali@aosp.bo.it

Italy1 site, 1 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, Bologna, 40138

    Francesca Vitali, MD, 051214463, francesca.vitali@aosp.bo.it

    Recruiting

Other trials in Italy

About this study

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

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

Read the detailed description

Premature infants represent an ever-increasing population, partly as a result of improved perinatal care in severely preterm deliveries. The prematurity condition itself and the interventions put in place in the management of this fragile category of patients can lead to even permanent changes in renal function, with potential both short-term and long-term effects (development of hypertension, chronic renal failure). The development of acute renal failure (IRA) represents one of the most frequent clinical risks, with a prevalence of 19% and an estimated incidence of 12-18%, and is an independent predictor of mortality, even after correction for potential confounding factors such as comorbidities, interventions, and demographic characteristics. This type of damage has multiple causes, including incomplete nephrogenesis, early exposure to nephrotoxic drugs, and the many nutritional problems involving the use of high-protein parenteral nutrition for long periods of time. Concomitant pathologic factors such as Botallo's duct patency, respiratory distress syndrome, and sepsis may also contribute, which may, moreover, themselves cause renal damage. It is apparent that the introduction of routine monitoring of renal function in premature infants may adiuvate the identification of infants at higher risk of developing damage and the development of individualized clinical and therapeutic approaches to safeguard the immature kidney. At present, there are no validated and established biomarkers in clinical practice for the assessment of reduced renal function in the premature infant, and often the impairment is recognized only late in life (i.e., when the ability to urinate is disrupted).

To date, the assessment of renal function in newborns has been based on the evaluation of serum creatinine: however, this analyte has proven to be a weak predictor of disease, as its levels turn out to be influenced by multiple factors such as gender, maternal renal function, age and degree of prematurity of the infant, muscle mass, current therapies, and endogenous metabolites (e.g., bilirubinemia), limiting its early predictive value with respect to the development of IRA. Creatininemia levels, moreover, do not provide specific information about the type of renal insult, and, during IRA, its changes occur later than those of estimated glomerular filtration rate (eGFR).In view of these limitations, new potential biomarkers of renal function have been investigated in order to identify molecules that can predict an early diagnosis of IRA and localize the possible site of damage, even in the subclinical phase. Among the molecules studied, the most promising currently appear to be: Cystatin C (CysC), epithelial growth factor (EGF), Neutrophil Gelatinase-Associated Lipocalin (NGAL), β2-Microglobulin, Osteopontin (OPN), kidney injury molecule 1 (KIM-1) and modulin (MOD). Important advantages of such biomarkers are the possibility of being determined noninvasively on urinary samples, without requiring additional blood samples, and the low analytical costs. In addition, the combined assessment of multiple markers could provide useful information to open new diagnostic-therapeutic perspectives in this population, shaping up as a tool to reduce short- and long-term renal morbidity. Despite promising preliminary evidence regarding the use of such markers for noninvasive serial monitoring of renal function in at-risk infants, however, further studies in the preterm population are needed before their application in normal clinical practice.

In addition, larger cohorts are needed to better assess the maturational effects of prematurity and those of other important factors, such as the presence of prenatal Doppler flowmetry alterations, on these biomarkers of renal function.

Conditions
Kidney Injury
Keywords
kidney injury, urinary biomarkers, premature newborns

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: through study completion, an average of 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2025
  2. Study start7 Dec 2022
  3. Primary completion15 Jun 2025 (estimated)
  4. Study completion15 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06781476
Sponsor's protocol ID
NEO-RENE
Status last verified
Oct 2024
First submitted
3 Dec 2024
Last updated
17 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Kidney Injury, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Francesca Vitali, MD (+390512144463, francesca.vitali@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2025.

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