Inflammatory Cytokine Quantification in Infants

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).

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Key information

Conditions

Sepsis Congenital Abnormalities Congenital Diaphragmatic Hernia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hernia Hernia, Diaphragmatic Hernias, Diaphragmatic, Congenital Infections Inflammation Internal Hernia Neonatal Cardiopulmonary Failure Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

Up to 2 month

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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 outcomes

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).

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Jul 2, 2010
Registry last updated: May 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed