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Trial record 27 of 225 for:    Recruiting, Not yet recruiting, Available Studies | Acute kidney injury

Acute Kidney Injury in Newborns With Perinatal Asphyxia

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ClinicalTrials.gov Identifier: NCT03617055
Recruitment Status : Not yet recruiting
First Posted : August 6, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
M. A. Sabra, Assiut University

Brief Summary:
The aim of the study is to investigate the role of serum cystatin C (sCysC) as an early predictor for both diagnosis and short term outcome evaluation of acute kidney injury (AKI) in neonates with perinatal asphyxia admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital

Condition or disease Intervention/treatment
Acute Kidney Injury Diagnostic Test: serum cystatin c

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Predictor of Acute Kidney Injury in Newborns With Perinatal Asphyxia
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : July 1, 2020

Intervention Details:
  • Diagnostic Test: serum cystatin c
    Blood sample for serum cystatin c will be taken on the first and third days of life for all neonates with clinical or laboratory signs of perinatal asphyxia who are admitted to NICU for early detection of AKI in the study group.


Primary Outcome Measures :
  1. serum cystatin C (sCysC) as an early predictor of acute kidney injury (AKI) in neonates with perinatal asphyxia. [ Time Frame: one year ]
    measuring serum cystatin c in neonates with perinatal asphyxia


Secondary Outcome Measures :
  1. is to determine the incidence of Acute kidney injury in neonates with perinatal asphyxia. [ Time Frame: one year ]


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
all full term neonates with documented perinatal asphyxiaby by one of the following indicators: (i) Presence of a sentinel hypoxic event immediately before or during delivery; (ii) History of fetal distress (bradycardia, late decelerations, absence of heart rate variability); (iii) Need for neonatal resuscitation at delivery; (iv) 1-min Apgar score <3 or 5-min Apgar score <7; or metabolic acidosis (BE > 10 in cord blood).
Criteria

Inclusion Criteria:

  • all full term neonates who are admitted to neonatal intensive care unit of Assiut University Children Hospital through the period from Jan. 2019 to Jan. 2020 with documented perinatal asphyxia

Exclusion Criteria:

preterm neonates < 37 weeks, neonates who died within the first 24 hours of admission, neonates with any congenital anomalies like skeletal, renal or urinary tract, neonates with AKI for any cause other than asphyxia and neonates with maternal history of renal failure .


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): NCT03617055


Contacts
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Contact: nafesa refaat, MD 00201148336224 nrefat@aun.edu.eg
Contact: Mohammed amir, MD 00201005689353 m_amir_riad@aun.edu.eg

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: M. A. Sabra, Mohammed Abdel tawab sabra, Assiut University
ClinicalTrials.gov Identifier: NCT03617055     History of Changes
Other Study ID Numbers: AKIPA
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M. A. Sabra, Assiut University:
kidney injury, asphyxia,cystatin c

Additional relevant MeSH terms:
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Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Asphyxia
Urologic Diseases
Death
Pathologic Processes
Cystatins
Cysteine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action