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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
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Infants With CHD Infants With Sepsis Infants Treated With ECMO
Hide Arm/Group Description Infants with Congenital Diaphragmatic Hernia (CHD) Infants who are culture positive for sepsis and require vasopressor support Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Period Title: Overall Study
Started 0 0 21
Completed 0 0 21
Not Completed 0 0 0
Arm/Group Title Infants With CHD Infants With Sepsis Infants Treated With ECMO Total
Hide Arm/Group Description Infants with Congenital Diaphragmatic Hernia (CHD) Infants who are culture positive for sepsis and require vasopressor support Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO) Total of all reporting groups
Overall Number of Baseline Participants 0 0 21 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 21 participants 21 participants
<=18 years 21 21
Between 18 and 65 years 0 0
>=65 years 0 0
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 0 participants 0 participants 21 participants 21 participants
1  (1) 1  (1)
Gender  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 21 participants 21 participants
Female 8 8
Male 13 13
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 0 participants 0 participants 21 participants 21 participants
21 21
1.Primary Outcome
Title TNF-alpha, Baseline
Hide Description This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants With CHD Infants With Sepsis Infants Treated With ECMO
Hide Arm/Group Description:
Infants with Congenital Diaphragmatic Hernia (CHD)
Infants who are culture positive for sepsis and require vasopressor support
Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Overall Number of Participants Analyzed 0 0 21
Mean (Standard Error)
Unit of Measure: pg/mL
8.88  (4.58)
2.Secondary Outcome
Title TNF-alpha, Maximum
Hide Description This study will quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis with cardiovascular instability, infants with a congenital diaphragmatic hernia defect, and infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO).
Time Frame up to 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Infants With CHD Infants With Sepsis Infants Treated With ECMO
Hide Arm/Group Description:
Infants with Congenital Diaphragmatic Hernia (CHD)
Infants who are culture positive for sepsis and require vasopressor support
Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Overall Number of Participants Analyzed 0 0 21
Mean (Standard Error)
Unit of Measure: pg/mL
33.1  (9.373)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infants With CHD Infants With Sepsis Infants Treated With ECMO
Hide Arm/Group Description Infants with Congenital Diaphragmatic Hernia (CHD) Infants who are culture positive for sepsis and require vasopressor support Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
All-Cause Mortality
Infants With CHD Infants With Sepsis Infants Treated With ECMO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Infants With CHD Infants With Sepsis Infants Treated With ECMO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/21 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infants With CHD Infants With Sepsis Infants Treated With ECMO
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/21 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christian Yost
Organization: University of Utah
Phone: 801/581-7052
EMail: christian.yost@hmbg.utah.edu
Layout table for additonal information
Responsible Party: Dr. Donald Null, University of Utah
ClinicalTrials.gov Identifier: NCT01155830    
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