Inflammatory Cytokine Quantification in Infants

Completed

• Conditions: Neonatal Cardiopulmonary Failure; Congenital Diaphragmatic Hernia; Sepsis

• Registration Number: NCT01155830
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-22
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-02
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Status Verified: 2014-12
• Results First Submitted: 2014-12-10
• Results First Submitted QC: 2015-05-01
• Last Update Submitted: 2015-05-01
• Results First Posted: 2015-05-04
• Last Update Posted: 2015-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TNF-alpha, Baseline	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

Name	Time	Method
TNF-alpha, Maximum	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).

Trial Locations

Locations (2)

Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States