This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for SI + CC Versus 3:1 C:V Ratio During Neonatal CPR (NCT02858583), a randomized na study. The primary outcome is Return of Spontaneous Circulation.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02858583 |
| Phase | NA |
| Condition | Heart Arrest, Birth Asphyxia, Bradycardia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 27 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Alberta |
| Results posted | Yes |
2. Clinical Question
Population
Newborn infants with asphyxia who require cardiopulmonary resuscitation. The registry summary refers to preterm ( >28 weeks or older) and term newborns; further eligibility details are not reported in the registry record.
Intervention
Chest compressions with sustained inflation, abbreviated CC+SI. The arm description specifies a sustained inflation with a PIP of 25-30 cmH2O over 45 seconds, followed by PEEP of 5-8 cm water and a heart-rate assessment.
Comparator
Chest compressions and ventilations in a 3:1 C:V ratio. The registry describes compressions at 90/min and 30 ventilations/min.
Primary question
Does CC+SI reduce the time needed to achieve return of spontaneous circulation compared with 3:1 C:V in asphyxiated newborns requiring CPR?
The primary endpoint is described as the duration of chest compression until heart rate is >60/min for 60sec, assessed during up to 60 Minutes of chest compression. The stated hypothesis concerns a shorter time to return of spontaneous circulation with CC+SI. This frames the question around how quickly circulation returns, rather than only whether it returns.
The registry also lists mortality, intraventricular hemorrhage, necrotizing enterocolitis, and epinephrine doses via umbilical venous catheter as secondary outcomes. Those outcomes provide additional clinical context, but their results are not reported in the registry record. The trial’s enrollment is 27; the record does not give the number assigned to each group for the primary endpoint or describe the endpoint results.
3. Trial Design
The registry identifies NCT02858583 as a randomized, parallel-group trial with single masking. It lists the sponsor as the University of Alberta and the status as completed. The recorded study start is 2017-10-19, and primary completion is dated 2022-09-22. Enrollment is 27. The phase is listed as NA.
Participants were assigned to CC+SI or 3:1 C:V. In the intervention description, sustained inflation is delivered while chest compressions are underway, followed by PEEP and a heart-rate assessment. The description includes a conditional phrase about heart rate being >60/min, but what follows that condition is not reported in the registry record. The comparator description specifies compressions at 90/min with 30 ventilations/min in a 3:1 ratio, described as consistent with current resuscitation guidelines.
There is an important design detail that is not clear from the registry record. Its design metadata says randomized and parallel, while an analysis note identifies a cluster-randomized design and cautions that simple individual-level recalculation would be misleading. The record does not explain the unit of randomization, how clustering was handled, or how the two descriptions relate. This matters because outcomes from participants treated within the same cluster may not be statistically independent.
The record does not report the allocation sequence method, allocation concealment, the identity of the masked party, or whether masking was maintained. It also does not report a protocol-level sample-size justification. These details should not be inferred from the trial’s enrollment or from the existence of a stated hypothesis.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Intervention (CC+SI) | Control (3:1 C:V) |
|---|---|---|
| STARTED | 12 | 15 |
| COMPLETED | 11 | 14 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Intervention (CC+SI) | Control (3:1 C:V) |
|---|---|---|
| Declined consent | 1 | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Intervention (CC+SI) | Control (3:1 C:V) | Total |
|---|---|---|---|---|
| Participants analysed | 11 | 14 | 25 | |
| Age, Categorical: <=18 years | Participants | 11 | 14 | 25 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 4 | 7 | 11 |
| Sex: Female, Male: Male | Participants | 7 | 7 | 14 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Return of Spontaneous Circulation, measured over up to 60 Minutes of chest compression.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | seconds |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is return of spontaneous circulation, measured as a duration in seconds. The registry describes the event as chest compression continuing until heart rate is >60/min for 60sec, with assessment during up to 60 Minutes of chest compression. The stated primary hypothesis is that CC+SI reduces the time required to achieve this endpoint compared with 3:1 C:V.
Time to an event can retain information about when an event occurs, rather than reducing the outcome to a simple yes-or-no status. In general, this can be useful when timing is central to the research question. It also requires clarity about how participants without the event during observation are handled, how follow-up ends, and what summary measure is used. The registry lists the primary measure as a median with an inter-quartile range, but does not report the group medians, inter-quartile ranges, or any analysis of the endpoint.
There is also a wording point to keep in mind: the endpoint description refers to a heart-rate threshold sustained for a specified period, while the overall question refers to return of spontaneous circulation. The record presents these as the operational endpoint and research question, respectively. Further endpoint adjudication details, including how the qualifying heart-rate period was confirmed, are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical limitation is that the registry record does not report the primary outcome results. It gives the endpoint definition and the planned comparison, but not group-specific times to return of spontaneous circulation, an effect estimate, a confidence interval, or a p-value. No direction or size of the observed primary effect can therefore be described from this record. The stated hypothesis is not itself evidence that the outcome differed between groups.
The registry lists 27 participants enrolled, but does not report how many contributed primary endpoint data, how many experienced return of spontaneous circulation, or how observations were handled when the event was not recorded during the stated observation period. Without those details, the endpoint’s observed distribution and the precision of any group comparison cannot be assessed. The median and inter-quartile range are named as the summary measure, but the corresponding values are absent.
The record lists five outcome measures and four secondary outcomes by name, but does not report their results. It also lists zero analyses. There is no reported sponsor analysis of the primary endpoint in the available record, despite an analysis note saying that only the sponsor’s own analysis is shown and that simple individual-level recalculation would be misleading for a cluster-randomized design. Accordingly, there is no result to recalculate or compare with an original analysis, and the reason for the mismatch between that note and the absence of analyses is not reported in the registry record.
The design descriptions also limit interpretation. Randomized parallel-group metadata appears alongside a note identifying cluster randomization. If assignment occurred by cluster, the analysis would need to account for the similarity of participants within clusters. The clusters, their number, and the statistical handling of clustering are not reported in the registry record. That uncertainty prevents a reader from determining whether an individual-level comparison would be appropriate.
In general, a confidence interval describes the range of effect sizes compatible with the data and the analysis assumptions; it conveys precision as well as direction. No confidence interval is reported for this endpoint. The absence of a reported estimate and interval means neither the size nor the uncertainty of the comparison can be evaluated. No conclusion about the comparative effect of the two approaches follows from the trial title, hypothesis, enrollment, or completion status alone.
9. Statistical Methods Explained
The registry identifies return of spontaneous circulation as the primary outcome and describes it as a time measured in seconds. It names the median and inter-quartile range as the summary statistics. However, it does not report the observed summaries, an effect estimate, or the analysis used to compare groups. The methods that follow explain general statistical considerations for this kind of question; they do not describe an analysis reported for this trial.
Why analyze time to an event?
General statistical explanation: a time-to-event outcome records both whether an event occurs and when it occurs during observation. That distinction can matter when the research question concerns speed of recovery, as it does. A time-to-event analysis can account for participants who have not experienced the event by the end of observation, rather than treating their unobserved event time as if it were known. The registry record does not state whether such an analysis was used, how observation ended for each infant, or how event-free participants were handled.
The listed median and inter-quartile range describe the distribution of times in a group: the median indicates its midpoint, and the inter-quartile range describes the central spread. These summaries alone do not establish whether groups differ, how precisely any difference is estimated, or how participants without a recorded event contribute. The record supplies no group-specific values or inferential method.
Why does randomization matter?
General statistical explanation: random assignment aims to make treatment groups comparable with respect to measured and unmeasured characteristics, on average. It does not guarantee identical groups, particularly in a small trial. Enrollment is 27, but baseline characteristics and group-specific enrollment are not reported in the registry record. Randomization also does not remove the need to specify how assignment was carried out or how the analysis followed the design.
The design description needs particular care because the registry metadata identifies a randomized parallel design, while an analysis note calls the trial cluster-randomized. General statistical explanation: if treatment is assigned to clusters, participants within the same cluster may have related outcomes. An analysis that treats every participant as independent can then misstate uncertainty. Appropriate analysis depends on the allocation unit and clustering structure. The registry record does not explain these details or report a cluster-adjusted method.
What does a confidence interval add?
General statistical explanation: an effect estimate conveys the direction and magnitude of a comparison, while a confidence interval communicates the precision of that estimate under the analysis assumptions. A wide interval indicates substantial uncertainty; a narrower interval indicates greater precision. A p-value, when reported, addresses compatibility with a specified null model, but it does not by itself describe the size or clinical meaning of an effect. For this trial, no primary effect estimate, confidence interval, or p-value is reported in the registry record.
Why can small samples be difficult to interpret?
General statistical explanation: with limited observations, estimates can be imprecise, and a few outcome events can materially affect a summary. This is especially relevant for outcomes that are uncommon or for analyses that must account for clustering. The trial’s enrollment is 27, but the record does not report endpoint event counts or cluster information. It is therefore not possible to assess the precision of a primary comparison or the extent to which clustering might influence it.
The registry includes sample-size assumptions for a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It notes that the effect to detect is a stated fraction of the observed effect and distinguishes time-to-event totals from participants per arm for other outcomes. No numerical planning estimates are reported in the registry record. Such planning illustrations are not observed trial results and do not establish the trial’s original design rationale. The protocol’s sample-size justification is not reported in the registry record.
What is over-dispersion?
General statistical explanation: over-dispersion occurs when outcome variability is greater than a model assumes. If a method ignores that extra variability, its uncertainty estimates may be too small. For clustered data, dependence within clusters is one possible source of excess variability relative to an independence assumption. The registry record does not report a model, dispersion assessment, or variance adjustment, so no such feature can be attributed to this trial.
Overall, the statistical record identifies a clinically framed time-to-event question and a proposed summary measure, but does not provide the analysis details or numerical primary results needed to evaluate the comparison. The note cautioning against individual-level recalculation reinforces the importance of understanding the allocation unit and sponsor analysis before interpreting any numerical comparison.
10. Multiplicity, Missing Data and Analysis Populations
The registry names return of spontaneous circulation as the primary outcome and lists mortality, intraventricular hemorrhage, necrotizing enterocolitis, and epinephrine doses via umbilical venous catheter as secondary outcomes. It reports five outcome measures and zero analyses. Results for the primary endpoint and secondary outcomes are not reported in the registry record.
Multiplicity concerns arise when several outcomes or comparisons are tested. General statistical explanation: the more inferences made, the greater the chance that an apparently notable finding could arise by chance if each is interpreted independently. A prespecified testing hierarchy or adjustment can address some multiplicity concerns. Whether such a plan existed, and whether any adjustment was made, is not reported in the registry record. The number of outcomes listed does not establish how many were formally tested.
Information about missing data is also absent. The record does not state how many participants had missing endpoint observations, why data might be missing, or what methods were used to handle missingness. It does not report analysis populations, such as whether participants were analyzed according to assigned group, nor does it explain exclusions or deviations from assignment. These omissions prevent assessment of how closely an analysis, if conducted, preserved the randomized comparison.
The record’s analysis note says the design is cluster-randomized and that simple individual-level recalculation would be misleading, but the allocation unit and sponsor analysis details are not reported. No analysis results are available to assess for multiplicity, missing-data handling, or population definitions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Intervention (CC+SI) | 2 | 11 | 18.2% |
| Control (3:1 C:V) | 4 | 14 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Intervention (CC+SI) | 2 of 11 |
| Control (3:1 C:V) | 8 of 14 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Intervention (CC+SI) | 0 of 11 |
| Control (3:1 C:V) | 0 of 14 |
Most frequent serious adverse event terms
| Event term | Organ system | Intervention (CC+SI) | Control (3:1 C:V) |
|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 11 | 2 of 14 |
| intraventricular hemorrhage | Nervous system disorders | 1 of 11 | 2 of 14 |
Serious events with the highest arm-level rate: pneumothorax (14.3%), intraventricular hemorrhage (14.3%).
The registry reports serious adverse event counts for 11 participants at risk in the CC+SI group, with 2 affected, and for 14 participants at risk in the 3:1 C:V group, with 4 affected. It reports zero other affected participants in each group. Deaths are listed as 2 in CC+SI and 8 in 3:1 C:V. The record does not provide an analysis comparing these counts, uncertainty estimates, or details about timing and attribution.
The listed serious terms are pneumothorax at 14.3% and intraventricular hemorrhage at 14.3%. The registry record does not state the denominator or group attribution for these percentages in the adverse-event listing. The secondary-outcome list also includes intraventricular hemorrhage, but the registry does not report its outcome results separately.
These figures should be read as descriptive registry counts, not as proof of a causal difference between groups. The adverse-event populations are not explained in relation to total enrollment, and event definitions, ascertainment procedures, follow-up completeness, and statistical comparisons are not reported in the registry record. The listed deaths and serious events therefore cannot be interpreted as comparative treatment effects from these data alone.
12. What the Result Does, and Does Not, Mean
The registry record establishes that the trial asked whether chest compressions with sustained inflation could reduce time to return of spontaneous circulation compared with a 3:1 compression-to-ventilation approach in newborns requiring CPR. It identifies a randomized parallel-group design, an enrollment of 27, and a primary endpoint based on heart rate exceeding the stated threshold for the stated duration. These details define the question, but they do not answer it.
No group-specific primary endpoint results, effect estimate, confidence interval, or p-value are reported. The results therefore do not establish which group had a shorter time to return of spontaneous circulation, how large any difference was, or how precisely it was estimated. The stated hypothesis is not a finding. Completion status and enrollment cannot substitute for outcome evidence.
The adverse-event listing gives counts for serious events, other affected participants, and deaths, as well as two serious-event terms with percentages. These descriptive data lack group-comparative analyses and important context, including the denominator for the listed percentages. They should not be treated as a definitive comparison of safety outcomes.
The record also leaves unresolved whether assignment was individual or by cluster. That distinction can affect the appropriate analysis and the uncertainty around an estimate. Without the allocation details, analysis method, endpoint results, and information on missing observations, the strength and precision of any treatment comparison cannot be judged.
In general, absence of reported results is not evidence that the groups were the same, and it is not evidence that one approach was better. The appropriate interpretation is narrower: the registry describes a research question and design, but does not report enough outcome or analysis information to determine the observed comparative result.
13. Why This Trial Matters Statistically
This trial raises statistical questions that are central to interpreting clinical research in a small, high-stakes setting. The research question concerns time to return of spontaneous circulation, so the timing of an event matters rather than only its presence or absence. Clear reporting of event definitions, observation periods, and handling of participants without a recorded event is essential to understanding such an endpoint.
The trial also highlights why the unit of randomization must be explicit. The registry describes a randomized parallel design, while an analysis note identifies cluster randomization and warns against simple individual-level recalculation. General statistical explanation: cluster assignment can create dependence among participants within the same cluster, affecting the precision of comparisons. A report should make the design and analysis relationship clear so readers can judge whether the uncertainty is estimated appropriately.
Small enrollment makes transparent reporting especially important. Group-specific outcome counts, effect estimates, and confidence intervals would help readers distinguish a potentially meaningful signal from an imprecise estimate. The registry record does not report the primary endpoint analysis, so the central statistical question remains unanswered in the posted results.
Finally, the record demonstrates that registration details and outcome evidence serve different purposes. The protocol question and listed outcomes show what the trial set out to examine. Results and methods are needed to evaluate what was observed and how reliable the comparison is. Neither a stated hypothesis nor completion status supplies that evidence.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary limitation is the absence of reported primary endpoint results. The record states the outcome definition and summary measure, but provides no group-specific median, inter-quartile range, effect estimate, confidence interval, or p-value. Secondary outcome results are also not reported.
Enrollment is 27, but group-specific enrollment for the primary analysis, endpoint event counts, and analysis populations are not reported. Missing-data amounts and handling, participant flow, exclusions, and protocol deviations are likewise not reported in the registry record. These gaps prevent assessment of how much information contributed to the primary comparison.
The design information is not fully reconciled: metadata describes randomized parallel groups, while an analysis note describes cluster randomization. The record does not identify the randomization unit, clusters, or the method used to account for clustering. That uncertainty is especially relevant because the note cautions against individual-level recalculation.
Other details that are not reported include the allocation sequence and concealment methods, who was masked, the sample-size justification, a prespecified statistical analysis plan, multiplicity procedures, and interim analyses. The record also does not explain the denominator or group attribution for the serious-event percentages. These limitations restrict interpretation of both efficacy and safety comparisons.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: SI + CC Versus 3:1 C:V Ratio During Neonatal CPR — NCT02858583.
- Registry record last updated 2024-08-29; status last verified 2024-08.
- Results first posted 2024-08-01.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02858583 is a completed randomized trial sponsored by the University of Alberta, with enrollment of 27. The registry lists a parallel-group design and single masking; an analysis note separately identifies cluster randomization, without clarifying the relationship between these descriptions.
The comparison is CC+SI versus 3:1 C:V during neonatal CPR. Return of spontaneous circulation, measured as a duration in seconds, is the primary outcome. Mortality, intraventricular hemorrhage, necrotizing enterocolitis, and epinephrine doses via umbilical venous catheter are listed as secondary outcomes.
The registry record does not report primary or secondary outcome analyses. It provides descriptive adverse-event counts but no comparative safety analysis. Consequently, the record describes the trial question and some design details, but does not provide the outcome estimates needed to assess the trial’s comparative findings.