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).

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84108
      • University of Utah
    • Salt Lake City, Utah, United States, 84112
      • Primary Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-alpha, 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).	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TNF-alpha, Maximum	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).	up to 2 weeks

Collaborators and Investigators

• Sponsor: University of Utah

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 30, 2010
• First Posted (Estimate): July 2, 2010

Study Record Updates

• Last Update Posted (Estimate): May 4, 2015
• Last Update Submitted That Met QC Criteria: May 1, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: ECMO; extracorporeal membrane oxygenation; inflammatory cytokines
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Congenital Abnormalities; Pathological Conditions, Anatomical; Internal Hernia; Sepsis; Hernia; Hernias, Diaphragmatic, Congenital; Hernia, Diaphragmatic
• Other Study ID Numbers: 39121