Inflammatory Cytokine Quantification in Infants

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Neonatal Cardiopulmonary Failure; Congenital Diaphragmatic Hernia; Sepsis

Study type: Observational

Funder types: Other

Identifiers

NCT01155830

39121

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: Under 2 months old

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 3 patient groups

Infants with CHD

Description:

Infants with Congenital Diaphragmatic Hernia (CHD)

Infants with sepsis

Description:

Infants who are culture positive for sepsis and require vasopressor support

Infants treated with ECMO

Description:

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