Inflammatory Cytokine Quantification in Infants

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01155830
First received: June 22, 2010
Last updated: May 1, 2015
Last verified: December 2014
Results First Received: December 10, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Sepsis
Congenital Diaphragmatic Hernia
Neonatal Cardiopulmonary Failure

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Infants With CHD Infants with Congenital Diaphragmatic Hernia (CHD)
Infants With Sepsis Infants who are culture positive for sepsis and require vasopressor support
Infants Treated With ECMO Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)

Participant Flow:   Overall Study
    Infants With CHD     Infants With Sepsis     Infants Treated With ECMO  
STARTED     0     0     21  
COMPLETED     0     0     21  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Infants With CHD Infants with Congenital Diaphragmatic Hernia (CHD)
Infants With Sepsis Infants who are culture positive for sepsis and require vasopressor support
Infants Treated With ECMO Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Total Total of all reporting groups

Baseline Measures
    Infants With CHD     Infants With Sepsis     Infants Treated With ECMO     Total  
Number of Participants  
[units: participants]
  0     0     21     21  
Age  
[units: participants]
       
<=18 years             21     21  
Between 18 and 65 years             0     0  
>=65 years             0     0  
Age  
[units: Days]
Mean (Standard Deviation)
          1  (1)     1  (1)  
Gender  
[units: participants]
       
Female             8     8  
Male             13     13  
Region of Enrollment  
[units: participants]
       
United States             21     21  



  Outcome Measures
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1.  Primary:   TNF-alpha, Baseline   [ Time Frame: Baseline ]

2.  Secondary:   TNF-alpha, Maximum   [ Time Frame: up to 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Christian Yost
Organization: University of Utah
phone: 801/581-7052
e-mail: christian.yost@hmbg.utah.edu


No publications provided


Responsible Party: Dr. Donald Null, University of Utah
ClinicalTrials.gov Identifier: NCT01155830     History of Changes
Other Study ID Numbers: 39121
Study First Received: June 22, 2010
Results First Received: December 10, 2014
Last Updated: May 1, 2015
Health Authority: United States: Institutional Review Board