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

History of Changes

Results First Received: December 10, 2014

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Sepsis Congenital Diaphragmatic Hernia Neonatal Cardiopulmonary Failure

Participant Flow

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Recruitment Details

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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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)

Participant Flow: Overall Study

	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
STARTED	0	0	21
COMPLETED	0	0	21
NOT COMPLETED	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
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)
Total	Total of all reporting groups

Baseline Measures

	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO	Total
Number of Participants [units: participants]	0	0	21	21
Age [units: participants]
<=18 years			21	21
Between 18 and 65 years			0	0
>=65 years			0	0
Age [units: Days] Mean (Standard Deviation)			1 (1)	1 (1)
Gender [units: participants]
Female			8	8
Male			13	13
Region of Enrollment [units: participants]
United States			21	21

Outcome Measures

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1. Primary:

TNF-alpha, Baseline [ Time Frame: Baseline ]

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2. Secondary:

TNF-alpha, Maximum [ Time Frame: up to 2 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Christian Yost
Organization: University of Utah
phone: 801/581-7052
e-mail: christian.yost@hmbg.utah.edu

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

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