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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

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

Condition or disease
Neonatal Acute Kidney Injury

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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Neonates at NICU in Assiut University Children Hospital Descriptive Study
Estimated Study Start Date : June 30, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Diagnosed as acute kidney injury
Sure diagnosed as acute kidney injury



Primary Outcome Measures :
  1. Diagnosed as acute kidney injury [ Time Frame: 10-21 days ]
    Diagnosis of acute kidney injury



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study of cases of acute kidney injury in neonates and its causes and it's outcome
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03528837


Contacts
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Contact: Mustafa Sh Khalf, Professor +20112110096 mostafa.tawfeek1@med.au.edu.eg
Contact: Ahlam B Ali, Lectuer +201006807866

Locations
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Egypt
Assiut university children hospital Recruiting
Assiut, Egypt
Contact: Mostafa Sh Khalf, Bachlear    +201112110096    mostafa.tawfeek1@med.au.edu.eg   
Sponsors and Collaborators
Assiut University

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Responsible Party: Mohammed Ali Abdelrhman, Resident of neonatology, Assiut University
ClinicalTrials.gov Identifier: NCT03528837     History of Changes
Other Study ID Numbers: AKI neonates
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

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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

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases