N/A
N=21
Inflammatory Cytokine Quantification in Infants
Sepsis · Congenital Diaphragmatic Hernia · Neonatal Cardiopulmonary Failure
Bottom Line
View on ClinicalTrials.gov: NCT01155830 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: TNF-alpha, Baseline — 8.88 pg/mL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY TNF-alpha, Baseline |
8.88 | — |
| SECONDARY TNF-alpha, Maximum |
33.1 | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01155830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.