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Intermittent Hypoxemia and Acute Kidney Injury Study (IHAKI Study) (IHAKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02837276
Recruitment Status : Completed
First Posted : July 19, 2016
Last Update Posted : September 4, 2019
Sponsor:
Collaborator:
University of Kentucky
Information provided by (Responsible Party):
Elie G. Abu Jawdeh, MD, University of Kentucky

Brief Summary:

This pilot study aims at investigating the relationship between intermittent hypoxemia (IH) and acute kidney injury (AKI) in preterm infants.

AIM 1: Test the hypothesis that intermittent hypoxemia is associated kidney injury in preterm infants, as reflected by a rise in serum creatinine.

AIM 2: Test the hypothesis that there is rise in acute kidney injury urinary biomarkers with increased intermittent hypoxemia.


Condition or disease
Intermittent Hypoxemia Acute Kidney Injury Preterm Infant

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intermittent Hypoxemia and Acute Kidney Injury Study (IHAKI Study)
Study Start Date : July 2016
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018



Primary Outcome Measures :
  1. Test the hypothesis that intermittent hypoxemia is associated with acute kidney injury, as reflected by a rise in creatinine or urinary biomarkers [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Preterm infants less than 32 weeks gestational age.
Criteria

Inclusion Criteria:

  • Preterm infants less than 32 weeks gestational age admitted to University of Kentucky neonatal intensive care unit

Exclusion Criteria:

  • Major congenital malformations

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): NCT02837276


Locations
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United States, Kentucky
University of Kentucky - Kentucky Children's Hospital
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Elie G. Abu Jawdeh, MD
University of Kentucky
Investigators
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Principal Investigator: Elie G Abu Jawdeh, MD University of Kentucky
Principal Investigator: Mina H Hanna, MD University of Kentucky
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Responsible Party: Elie G. Abu Jawdeh, MD, Assistant Professor of Pediatrics, University of Kentucky
ClinicalTrials.gov Identifier: NCT02837276    
Other Study ID Numbers: 13-0232-F1V
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Elie G. Abu Jawdeh, MD, University of Kentucky:
Intermittent Hypoxemia
Acute Kidney Injury
Preterm infant
Additional relevant MeSH terms:
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Acute Kidney Injury
Hypoxia
Wounds and Injuries
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Signs and Symptoms, Respiratory