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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03528837
Other study ID # AKI neonates
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 30, 2018
Est. completion date August 1, 2019

Study information

Verified date May 2018
Source Assiut University
Contact Mustafa Sh Khalf, Professor
Phone +20112110096
Email mostafa.tawfeek1@med.au.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 clinically un measured products


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date August 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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

Study Design


Locations

Country Name City State
Egypt Assiut university children hospital Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnosed as acute kidney injury Diagnosis of acute kidney injury 10-21 days
See also
  Status Clinical Trial Phase
Recruiting NCT02306642 - Follow-up of AKI in Neonates During Childhood Years N/A