Inflammatory Cytokine Quantification in Infants

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

21 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transfusion-related Inflammatory Cytokine and Neutrophil Extracellular Trap Quantification in Neonates

NCT01735552

Anemia of Prematurity Necrotizing Enterocolitis

TERMINATED

Neuroimaging and Neuromonitoring in Critically Ill Children With Sepsis

NCT03055455

Septic Shock

COMPLETED

Preliminary Study of Pediatric Diaphragmatic Elastography

NCT06666140

Congenital Diaphragmatic Hernia

NOT_YET_RECRUITING NA

Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.

NCT03751397

Renal Biomarkers in Children

COMPLETED

Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH

NCT02530073

Congenital Diaphragmatic Hernias

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Congenital Diaphragmatic Hernia Neonatal Cardiopulmonary Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Infants with CHD

Infants with Congenital Diaphragmatic Hernia (CHD)

No interventions assigned to this group

Infants with sepsis

Infants who are culture positive for sepsis and require vasopressor support

No interventions assigned to this group

Infants treated with ECMO

Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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