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Inflammatory Cytokine Quantification in Infants

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ClinicalTrials.gov Identifier: NCT01155830
Recruitment Status : Completed
First Posted : July 2, 2010
Results First Posted : May 4, 2015
Last Update Posted : May 4, 2015
Sponsor:
Information provided by:
University of Utah

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Sepsis
Congenital Diaphragmatic Hernia
Neonatal Cardiopulmonary Failure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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

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.
No text entered.

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 
Overall Participants Analyzed 
[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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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



Responsible Party: Dr. Donald Null, University of Utah
ClinicalTrials.gov Identifier: NCT01155830     History of Changes
Other Study ID Numbers: 39121
First Submitted: June 22, 2010
First Posted: July 2, 2010
Results First Submitted: December 10, 2014
Results First Posted: May 4, 2015
Last Update Posted: May 4, 2015