Neonatal Acute Kidney InjuryNCT03528837
Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
An observational study of Neonatal Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other… Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Acute Kidney Injury
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2018to 1 Aug 2019
- 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 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Study of cases of acute kidney injury in neonates and its causes and it's outcome
Who may be able to join
- All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study.
Who cannot join
- Cases with chronic renal affection Any case with congenital anomalies
Trial locations and contacts
1 site in 1 country.
Ahlam B Ali, Lectuer contact
Egypt1 site
Assiut university children hospital
Asyut
Mostafa Sh Khalf, Bachlear, +201112110096, mostafa.tawfeek1@med.au.edu.eg
About this study
Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other clinically un measured products
Read the detailed description
Acute kidney injury (AKI) is an under-recognized morbidity of neonates; the incidence remains unclear due to the absence of a unified definition of AKI in this population and because previous studies have varied greatly in screening for AKI with serum creatinine and urine output assessments. Premature infants may be born with less than half of the nephrons compared with term neonates, predisposing them to chronic kidney disease (CKD) early on in life and as they age. AKI can also lead to CKD, and premature infants with AKI may be at very high risk for long-term kidney problems. AKI in neonates is often multifactorial and may result from prenatal, perinatal, or postnatal insults as well as any combination thereof.
- Conditions
- Neonatal 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 |
|---|---|---|
| Diagnosed as acute kidney injury | Sure diagnosed as acute kidney injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosed as acute kidney injury
Diagnosis of acute kidney injury
Measured: 10-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start30 Jun 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ali Abdelrhman, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03528837
- Sponsor's protocol ID
- AKI neonates
- Status last verified
- May 2018
- First submitted
- 6 Apr 2018
- Last updated
- 18 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
- ClinicalTrials.gov ID
- NCT03528837
- Acronym / sponsor ID
- AKI neonates
- Conditions
- Neonatal Acute Kidney Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Aug 2019 (estimated)
- First posted
- 18 May 2018 (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.
Acute kidney injury (AKI) is a complex disorder with clinical manifestations ranging from mild dysfunction to complete anuric kidney failure. Its leads to sudden and rapid decline in renal excretory function within hours to days,accompanied by accumulation of nitrogenous waste products such creatinine,urea and other clinically un measured products
Detailed description
Acute kidney injury (AKI) is an under-recognized morbidity of neonates; the incidence remains unclear due to the absence of a unified definition of AKI in this population and because previous studies have varied greatly in screening for AKI with serum creatinine and urine output assessments. Premature infants may be born with less than half of the nephrons compared with term neonates, predisposing them to chronic kidney disease (CKD) early on in life and as they age. AKI can also lead to CKD, and premature infants with AKI may be at very high risk for long-term kidney problems. AKI in neonates is often multifactorial and may result from prenatal, perinatal, or postnatal insults as well as any combination thereof.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosed as acute kidney injury | – | –Sure diagnosed as acute kidney injury |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Study of cases of acute kidney injury in neonates and its causes and it's outcome
Key inclusion criteria (1 listed)
- All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study.
Key exclusion criteria (1 listed)
- Cases with chronic renal affection Any case with congenital anomalies
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
Diagnosed as acute kidney injury
Time frame: 10-21 days
Diagnosis of acute kidney injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
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Improving Preterm Kidney Outcomes With Caffeine
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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. This study is not recruiting at the moment.
Ahlam B Ali, Lectuer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Acute Kidney Injury, run by Assiut University at 1 site in Egypt.
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 1 inclusion and 1 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 18 May 2018. 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 Egypt. 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 Mustafa Sh Khalf, Professor (+20112110096, mostafa.tawfeek1@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosed as acute kidney injury (time frame: 10-21 days). 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 18 May 2018.