Inflammatory Cytokine Quantification in Infants

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01155830
First received: June 22, 2010
Last updated: May 1, 2015
Last verified: December 2014
  Purpose

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
Sepsis
Congenital Diaphragmatic Hernia
Neonatal Cardiopulmonary Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • TNF-alpha, Baseline [ Time Frame: Baseline ] [ 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).


Secondary Outcome Measures:
  • TNF-alpha, Maximum [ 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).


Enrollment: 21
Study Start Date: June 2010
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
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)

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.

  Eligibility

Ages Eligible for Study:   up to 2 Months
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01155830

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

No publications provided

Responsible Party: Dr. Donald Null, University of Utah
ClinicalTrials.gov Identifier: NCT01155830     History of Changes
Other Study ID Numbers: 39121
Study First Received: June 22, 2010
Results First Received: December 10, 2014
Last Updated: May 1, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hernia, Diaphragmatic
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on August 02, 2015