Inflammatory Cytokine Quantification in Infants

Sepsis Clinical Trial

Official title:

Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155830
• Other study ID #: 39121
• Status: Completed
• Phase: N/A
• First received: June 22, 2010
• Last updated: May 1, 2015
• Start date: June 2010
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Diaphragmatic Hernia
• Hernia, Diaphragmatic
• Neonatal Cardiopulmonary Failure
• Sepsis

Locations

Country	Name	City	State
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No