Acute Kidney InjuryNCT07083284
Acute Kidney Injury in Neonatal ICU in Assuit University
An observational study of Acute Kidney Injury, run by Assiut University.
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)
- Conditions
- Acute Kidney Injury
- 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 group | Role | What they receive |
|---|---|---|
| study group | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted24 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Zakaria Mostafa, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Neonatal ICU in Assuit University
- ClinicalTrials.gov ID
- NCT07083284
- Acronym / sponsor ID
- AKI neonatal ICU
- Conditions
- Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | –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 qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (3 listed)
- • 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).
Key exclusion criteria (3 listed)
- • Post-operative neonates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidance of acute kidney injery
Time frame: 30 day
incidance of acute kidney injery of neonate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
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.