Inflammatory Cytokine Quantification in Infants

• ClinicalTrials.gov Identifier: NCT01155830
• Recruitment Status: Completed
• First Posted: July 2, 2010
• Results First Posted: May 4, 2015
• Last Update Posted: May 4, 2015
• Sponsor: University of Utah
• Information provided by: University of Utah

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Conditions: Sepsis; Congenital Diaphragmatic Hernia; Neonatal Cardiopulmonary Failure
• Enrollment: 21

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
Arm/Group Description	Infants with Congenital Diaphragmatic Hernia (CHD)	Infants who are culture positive for sepsis and require vasopressor support	Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Period Title: Overall Study
Started	0	0	21
Completed	0	0	21
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Infants With CHD	Infants With Sepsis	Infants Treated With ECMO	Total
Arm/Group Description		Infants with Congenital Diaphragmatic Hernia (CHD)	Infants who are culture positive for sepsis and require vasopressor support	Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)	Total of all reporting groups
Overall Number of Baseline Participants		0	0	21	21
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Number; Unit of measure: Participants	Number Analyzed	0 participants	0 participants	21 participants	21 participants
<=18 years				21	21
Between 18 and 65 years				0	0
>=65 years				0	0
Age, Continuous; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	0 participants	0 participants	21 participants	21 participants
				1 (1)	1 (1)
Gender; Measure Type: Number; Unit of measure: Participants	Number Analyzed	0 participants	0 participants	21 participants	21 participants
Female				8	8
Male				13	13
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	0 participants	0 participants	21 participants	21 participants
				21	21

Outcome Measures

1. Primary Outcome

Title	TNF-alpha, Baseline
Description	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).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
Arm/Group Description:	Infants with Congenital Diaphragmatic Hernia (CHD)	Infants who are culture positive for sepsis and require vasopressor support	Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Overall Number of Participants Analyzed	0	0	21
Mean (Standard Error); Unit of Measure: pg/mL
			8.88 (4.58)

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
Arm/Group Description:	Infants with Congenital Diaphragmatic Hernia (CHD)	Infants who are culture positive for sepsis and require vasopressor support	Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
Overall Number of Participants Analyzed	0	0	21
Mean (Standard Error); Unit of Measure: pg/mL
			33.1 (9.373)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
Arm/Group Description	Infants with Congenital Diaphragmatic Hernia (CHD)	Infants who are culture positive for sepsis and require vasopressor support	Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
All-Cause Mortality
	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--
Serious Adverse Events
	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/21 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Infants With CHD	Infants With Sepsis	Infants Treated With ECMO
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	0/0	0/21 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

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
• EMail: christian.yost@hmbg.utah.edu

• Responsible Party: Dr. Donald Null, University of Utah
• ClinicalTrials.gov Identifier: NCT01155830
• Other Study ID Numbers: 39121
• First Submitted: June 22, 2010
• First Posted: July 2, 2010
• Results First Submitted: December 10, 2014
• Results First Posted: May 4, 2015
• Last Update Posted: May 4, 2015