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Inflammatory Cytokine Quantification in Infants

This study is currently recruiting participants.
Verified January 2013 by University of Utah
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01155830
First received: June 22, 2010
Last updated: January 22, 2013
Last verified: January 2013
History of Changes

June 22, 2010
January 22, 2013
June 2010
June 2014   (final data collection date for primary outcome measure)
Quantification of inflammatory cytokine profiles in three neonatal diseases. [ Time Frame: up to 2 weeks ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01155830 on ClinicalTrials.gov Archive Site
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Inflammatory Cytokine Quantification in Infants
Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy

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).

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Infants admitted into the NICU at the University of Utah Health Sciences Centers and Primary Children's Medical Center.
  • Sepsis
  • Congenital Diaphragmatic Hernia
  • Neonatal Cardiopulmonary Failure
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  • 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)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
up to 2 Months
No
Not Provided
United States
 
NCT01155830
39121
No
Dr. Donald Null, University of Utah
University of Utah
Not Provided
Principal Investigator: Donald Null, MD University of Utah
University of Utah
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP