We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Inflammatory Cytokine Quantification in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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).

Condition or disease
Sepsis Congenital Diaphragmatic Hernia Neonatal Cardiopulmonary Failure

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
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy
Study Start Date : June 2010
Primary Completion Date : May 2013
Study Completion Date : June 2013


Group/Cohort
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)



Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155830


Locations
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84108
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Donald Null, MD University of Utah

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

Keywords provided by University of Utah:
inflammatory cytokines
extracorporeal membrane oxygenation
ECMO

Additional relevant MeSH terms:
Sepsis
Hernia
Hernia, Diaphragmatic
Hernias, Diaphragmatic, Congenital
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Pathological Conditions, Anatomical
Congenital Abnormalities