Inflammatory Cytokine Quantification in Infants

• Sponsor: University of Utah (Other)
• Overall Status: Completed
• CT.gov ID: NCT01155830
• Collaborator: (none)
• Enrollment: 21
• Locations: 2
• Duration (Months): 36
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Congenital Diaphragmatic Hernia; Neonatal Cardiopulmonary Failure

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 Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Inflammatory Cytokine Quantification in Infants With Documented Sepsis, Congenital Diaphragmatic Hernia and/or ECMO Therapy
• Study Start Date: Jun 1, 2010
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 2 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Utah	Salt Lake City	Utah	United States	84108
2	Primary Children's Medical Center	Salt Lake City	Utah	United States	84112

Sponsors and Collaborators

• University of Utah

Investigators

• Principal Investigator: Donald Null, MD, University of Utah

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01155830
• Other Study ID Numbers: 39121
• First Posted: Jul 2, 2010
• Last Update Posted: May 4, 2015
• Last Verified: Dec 1, 2014

• Keywords provided by , ,: inflammatory cytokines; extracorporeal membrane oxygenation; ECMO
• Additional relevant MeSH terms: Sepsis; Hernias, Diaphragmatic, Congenital; Hernia; Hernia, Diaphragmatic

Study Results

Participant Flow

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 Participants	0	0	21	21
Age (participants) [Number]
<=18 years	21 Infinity	21 Infinity
Between 18 and 65 years	0 NaN	0 NaN
>=65 years	0 NaN	0 NaN
Age (Days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Days]	1 (1)	1 (1)
Gender (participants) [Number]
Female	8 Infinity	8 Infinity
Male	13 Infinity	13 Infinity
Region of Enrollment (participants) [Number]
United States	21 Infinity	21 Infinity

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)
Measure Participants	0	0	21
Mean (Standard Error) [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)
Measure Participants	0	0	21
Mean (Standard Error) [pg/mL]	33.1 (9.373)

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Infants With CHD		Infants With Sepsis		Infants Treated With ECMO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/21 (0%)
Other (Not Including Serious) Adverse Events
	Infants With CHD		Infants With Sepsis		Infants Treated With ECMO
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/21 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.