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Acute Kidney InjuryNCT07083284

Acute Kidney Injury in Neonatal ICU in Assuit University

An observational study of Acute Kidney Injury, run by Assiut University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

The kidneys of neonates are particularly susceptible to hypoperfusion because of the physiologic characteristics of neonatal kidneys, including high renal vascular resistance, high plasma renin activity, low glomerular filtration rate (GFR), decreased intracortical perfusion rate, and decreased reabsorption of sodium… Read more about this study

Who is it for?
Ages 1 day to 30 days
Conditions the study is for
Acute Kidney Injury
How many people
100 participants
Where
No sites listed yet
Study dates
1 Aug 2025to 1 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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 1 day to 30 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: patients with Age from 0 to 28 days presented with acute kidney injury on based of raised renal chemistry, An increase in serum creatinine (e.g., >0.3 mg/dL or >50% from baseline) , Oliguria (urine output less than 1 mL/kg/h for more than 6 hours).

Who may be able to join

  • • Age from 0 to 28 days presented with acute kidney injury on based of raised renal chemistry, An increase in serum creatinine (e.g., >0.3 mg/dL or >50% from baseline) , Oliguria (urine output less than 1 mL/kg/h for more than 6 hours).
  • Other biomarkers of kidney injury (e.g., elevated urinary biomarkers such as NGAL, KIM-1) ( if available)
  • Parental consent: Neonates whose parents or legal guardians provide informed consent for participation in the study

Who cannot join

  • • Post-operative neonates.
  • Cases with gross congenital anomalies of the kidney and urinary tract.
  • Neonates with a maternal history of kidney failure.

About this study

The kidneys of neonates are particularly susceptible to hypoperfusion because of the physiologic characteristics of neonatal kidneys, including high renal vascular resistance, high plasma renin activity, low glomerular filtration rate (GFR), decreased intracortical perfusion rate, and decreased reabsorption of sodium in proximal convoluted tubules in the first day of neonatal life (1) Acute kidney injury (AKI) occurs commonly in the neonatal intensive care unit (NICU) and is associated with increase morbidity and mortality. Furthermore, those who develop neonatal AKI may be at increased risk for the development of chronic kidney disease (CKD). With ongoing study, the definition of neonatal AKI has evolved and been standardized, improving our ability to quantify and describe the epidemiology and outcomes associated with neonatal AKI (2) Acute kidney injury (AKI) is defined as kidneys' inability to excrete nitrogenous waste products and maintain fluid and electrolyte homeostasis. It is fairly common in newborn population and is a major contributing factor of neonatal mortality and morbidity (3) Acute kidney injury (AKI), frequently involving patients admitted to the neonatal intensive care unit (NICU), is associated with poor outcomes and affects 18-70% of critically ill neonates. Although the real incidence of AKI in neonates is uncertain, with wide and various ranges, due to several definitions and diagnostic methods, more immature and ill neonates are characterized by the highest risk of AKI (4) Patients with congenital heart disease, perinatal asphyxia, premature birth or a low birth weight, and necrotizing enterocolitis, as well as neonates who receive nephrotoxic medications or require extracorporeal life support, represent high-risk populations. According to the Worldwide Acute Kidney Injury Epidemiology in Neonates (AWAKEN) data, one episode of AKI, related to an increased length of hospitalization and mortality rate, was observed in 30% of critically ill neonates (5) To apply personalized therapeutic approaches to AKI, an adequate and early diagnosis could reduce or avoid subclinical and precocious renal injuries and their related effects, requiring chronic follow-up, as suggested by the Clinical Practice Guidelines for Acute Kidney Injury (KDIGO), recommending a nephrological evaluation after three months, if an AKI event occurs (6)

The precocious diagnosis of AKI based on urinary output and serum creatinine (sCr) levels represents one of the hardest challenges in clinical practice. Several biomarkers and clinical scores were assessed to predict neonatal AKI, to identify the stage of injury and not the damage, to anticipate late rises in sCr values and to reveal an already compromised renal function (7)

Medical subject headings
Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07083284
Study groupRoleWhat they receive
study grouppatients with Age from 0 to 28 days presented with acute kidney injury on based of raised renal chemistry, An increase in serum creatinine (e.g., >0.3 mg/dL or >50% from baseline) , Oliguria (urine output less than 1 mL/kg/h for more than 6 hours).

What is being measured

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

  1. incidance of acute kidney injery

    incidance of acute kidney injery of neonate

    Measured: 30 day

Timeline

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

  1. First posted24 Jul 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion1 Sep 2026 (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
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07083284
Sponsor's protocol ID
AKI neonatal ICU
Status last verified
Jul 2025
First submitted
16 Jul 2025
Last updated
24 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Kidney Injury, run by Assiut University.

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 3 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: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

incidance of acute kidney injery (time frame: 30 day). 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 24 Jul 2025.

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