Objectives, outcome measures and methods of analysis for Fast I(n)dentification of Pathogens in Neonates pilot study
| Objective | Outcome measure | Method of analysis |
| Co-primary objectives | ||
| 1. Recruitment. | Successful recruitment is defined as ≥80% of eligible patients. | Proportion |
| 2. Sample collection. | Successful sample collection is defined as ≥80% of the blood samples for recruited patients at the first time point. | Proportion |
| 3. Ability to perform NGS on blood samples of premature and term neonates at MCH with suspected sepsis. | Description of mechanical or process issues | Descriptive only |
| Secondary objectives | ||
| 1. To describe the blood NGS pathogen output in order to gain a preliminary understanding of the potential clinical role of NGS testing in neonates with suspected sepsis. | NGS pathogen output (taxonomy, reads, plausibility from panel review) | Descriptive statistics ± case discussions |
| 2. To describe the serum levels and diagnostic accuracy of biomarkers cfDNA and protein C at time points of 0 and 24 hours between neonates with clinical sepsis, culture-proven sepsis and without sepsis. | Levels of blood cfDNA and protein C, sensitivity and specificity (%), likelihood ratios | Descriptive statistics, diagnostic accuracy measures with CIs |
| 3. To compare the sensitivity and specificity of NGS for bacterial identification compared with gold-standard aerobic blood culture. | Sensitivity and specificity (%) | Proportion and CIs |
| 4. To determine blood sample NGS laboratory process time. | Process time from thawing sample to sequence acquisition (hours) | Descriptive only |
| 5. To determine consent rate using an exception to consent (deferred consent). | The target consent rate is ≥80% of families approached | Proportion |
cfDNA, cell-free DNA; CI, confidence interval; MCH, McMaster Children’s Hospital; NGS, next-generation sequencing.