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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

Tracking Information
First Submitted Date June 22, 2010
First Posted Date July 2, 2010
Results First Submitted Date December 10, 2014
Results First Posted Date May 4, 2015
Last Update Posted Date May 4, 2015
Study Start Date June 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 1, 2015)
TNF-alpha, Baseline [ Time Frame: Baseline ]
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).
Original Primary Outcome Measures
 (submitted: June 30, 2010)
Quantification of inflammatory cytokine profiles in three neonatal diseases. [ Time Frame: up to 2 weeks ]
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).
Change History
Current Secondary Outcome Measures
 (submitted: May 1, 2015)
TNF-alpha, Maximum [ Time Frame: up to 2 weeks ]
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).
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Inflammatory Cytokine Quantification in Infants
Official Title Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy
Brief Summary This study proposes to quantify inflammatory cytokine profiles in three neonatal disease states, namely, neonatal sepsis, 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).
Detailed Description Very small blood samples (500 microliters) will be collected serially in these patients and analyzed with current cytokine array technology. A convenience sample of 60 patients, 20 with each of these diagnoses, will be collected over a 2 year period. These data will provide baseline information for possible therapeutic intervention with agents that enhance or suppress specific mediators, or adjust mediator balance to promote patient healing.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Infants admitted into the NICU at the University of Utah Health Sciences Centers and Primary Children's Medical Center.
Condition
  • Sepsis
  • Congenital Diaphragmatic Hernia
  • Neonatal Cardiopulmonary Failure
Intervention Not Provided
Study Groups/Cohorts
  • 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)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 1, 2015)
21
Original Estimated Enrollment
 (submitted: June 30, 2010)
60
Actual Study Completion Date June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Gestational age ≥ 34 weeks,
  • Indwelling vascular catheter available for blood draws,
  • Documented culture positive sepsis on vasopressors , and/or
  • Congenital diaphragmatic hernia (CDH), and/or
  • ECMO therapy

Exclusion Criteria:

  • Other major congenital anomalies
  • Lack of parental consent
Sex/Gender
Sexes Eligible for Study: All
Ages up to 2 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01155830
Other Study ID Numbers 39121
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr. Donald Null, University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: Donald Null, MD University of Utah
PRS Account University of Utah
Verification Date December 2014