Trial Outcomes & Findings for Inflammatory Cytokine Quantification in Infants (NCT NCT01155830)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

21 participants

Primary outcome timeframe

Baseline

Results posted on

2015-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	0	0	21
Overall Study COMPLETED	0	0	21
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inflammatory Cytokine Quantification in Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	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 n=21 Participants Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	—	—	21 participants n=5 Participants	21 participants n=4 Participants
Age, Categorical Between 18 and 65 years	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Age, Categorical >=65 years	—	—	0 participants n=5 Participants	0 participants n=4 Participants
Age, Continuous	—	—	1 Days STANDARD_DEVIATION 1 • n=5 Participants	1 Days STANDARD_DEVIATION 1 • n=4 Participants
Gender Female	—	—	8 participants n=5 Participants	8 participants n=4 Participants
Gender Male	—	—	13 participants n=5 Participants	13 participants n=4 Participants
Region of Enrollment United States	—	—	21 participants n=5 Participants	21 participants n=4 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	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 n=21 Participants Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
TNF-alpha, Baseline	—	—	8.88 pg/mL Standard Error 4.58

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	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 n=21 Participants Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
TNF-alpha, Maximum	—	—	33.1 pg/mL Standard Error 9.373

Adverse Events

Infants With CHD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infants With Sepsis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Infants Treated With ECMO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christian Yost

University of Utah

Phone: 801/581-7052

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place