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Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study

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ClinicalTrials.gov Identifier: NCT03528837
Recruitment Status : Not yet recruiting
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mohammed Ali Abdelrhman, Assiut University

Tracking Information
First Submitted Date April 6, 2018
First Posted Date May 18, 2018
Last Update Posted Date May 18, 2018
Estimated Study Start Date June 30, 2018
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 17, 2018)
Diagnosed as acute kidney injury [ Time Frame: 10-21 days ]
Diagnosis of acute kidney injury
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
Official Title Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
Brief 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 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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Study of cases of acute kidney injury in neonates and its causes and it's outcome
Condition Neonatal Acute Kidney Injury
Intervention Not Provided
Study Groups/Cohorts Diagnosed as acute kidney injury
Sure diagnosed as acute kidney injury
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: May 17, 2018)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 1, 2019
Estimated Primary Completion Date July 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All cases of acute kidney injury in neonates who will be admitted to NICU Assiut University Children Hospital during the duration of the study.

Exclusion Criteria:

  • Cases with chronic renal affection Any case with congenital anomalies
Sex/Gender
Sexes Eligible for Study: All
Ages up to 28 Days   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Mustafa Sh Khalf, Professor +20112110096 mostafa.tawfeek1@med.au.edu.eg
Contact: Ahlam B Ali, Lectuer +201006807866
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03528837
Other Study ID Numbers AKI neonates
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement Not Provided
Responsible Party Mohammed Ali Abdelrhman, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date May 2018