N/A
N=27
SI + CC Versus 3:1 C:V Ratio During Neonatal CPR
Heart Arrest · Birth Asphyxia · Bradycardia
Bottom Line
View on ClinicalTrials.gov: NCT02858583 ↗Enrolled (actual)
27
Serious AEs
24.0%
Results posted
Aug 2024
Primary outcome: Primary: Return of Spontaneous Circulation — 90; 615 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CC+SI (Procedure); 3:1 C:V (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Alberta
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Return of Spontaneous Circulation |
90; 615 | — |
| SECONDARY Mortality |
2; 8 | — |
| SECONDARY Rate of Brain Injury - Intraventricular Hemorrhage |
1; 2 | — |
| SECONDARY Necrotizing Enterocolitis |
0; 0 | — |
| SECONDARY Epinephrine Doses Via Umbilical Venous Catheter |
2.3; 2 | — |
Summary
Research question In newborn infants requiring CPR, does CC superimposed by sustained inflation compared to 3:1 compression to ventilation ratio improves return of spontaneous circulation?
Overall objective: CC superimposed by sustained inflation will improve short- and long-term outcomes in preterm (>28 weeks or older) and term newborns.
Hypothesis to be tested Primary hypothesis: By using CC superimposed by sustained inflation (CC+SI) during CPR the time needed to achieve return of spontaneous circulation (ROSC) compared to the current 3:1 compression to ventilation (C:V) will be reduced in asphyxiated newborns.
Eligibility Criteria
Inclusion Criteria
- Infants (term or preterm infants >28 weeks' gestation) requiring CC in the delivery room will be eligible for the trial.
Exclusion Criteria
- Infants will be excluded if they have a congenital abnormality or condition that might have an adverse effect on breathing or ventilation (e.g. congenital diaphragmatic hernia), or congenital heart disease requiring intervention in the neonatal period. Infants would be also excluded if their parents refused to give consent to this study.
Data sourced from ClinicalTrials.gov (NCT02858583). 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.