Treating Respiratory Emergencies in Children Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treating Respiratory Emergencies in Children Study (NCT06074185), a non-randomized phase 2 study. The primary outcome is Proportion of Patients Admitted to the Hospital in Each Group.

2. Clinical Question

The study addresses whether introducing an EMS treatment protocol for children with acute wheezing is associated with a difference in hospital admission compared with existing EMS care. Its rationale describes the potential importance of earlier prehospital treatment and notes that treatments used in emergency departments are not routinely included in many EMS protocols. That background explains the clinical motivation, but it is not evidence about the results of this trial.

The registry describes a pilot study and lists a secondary outcome concerning the NIH Patient-Reported Outcomes Measurement Information Systems Asthma Impact Scale. It does not report results for that measure. Consequently, the available record identifies the question and outcomes but does not establish what happened to participants in either arm.

3. Trial Design

The registry identifies this as a Phase 2, parallel-group, non-randomized study with no masking. Its listed enrollment is 44, and its status is completed. The study is described in the registry summary as a three-site pilot trial. The record lists Oregon Health and Science University as sponsor, with a start date of 2024-01-19 and a primary completion date of 2025-02-28.

The two care strategies are continued current care and a treatment bundle with checklist. The first arm follows the existing EMS protocol; the second implements a new protocol with the study bundle. Ipratropium bromide is listed as an intervention, but the record does not give enough detail to establish exactly how it was used in relation to each arm or to describe every component of the bundle.

Non-randomized allocation matters when interpreting comparisons. Random assignment, when used, is intended to make groups comparable on average with respect to both measured and unmeasured characteristics. In this study, assignment was not random, and the registry record does not report the assignment process or adjustments intended to address baseline differences. As a result, a difference between groups, if reported, could reflect differences in the participants, sites, care context, or other factors in addition to the treatment strategy.

No masking is listed. This means the registry does not describe a design in which participants or study personnel were masked to the assigned approach. The practical consequences can differ by outcome: a hospital admission is a clinical event, while other measures may involve reporting or assessment. The registry does not explain how outcome assessment was conducted or whether any outcome assessors were masked.

The record lists 2 outcome measures, including hospital admission and a secondary asthma impact measure, and 0 analyses. It does not report the statistical analysis plan, participant flow, baseline characteristics, site-level enrollment, or details of the allocation process. These omissions limit evaluation of how the study was conducted and how any between-arm comparison should be interpreted. Completion status indicates that the registry marks the study completed; it does not by itself establish that every outcome result or analysis is posted.

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.

Pre-intervention (6 months)

Reasons for not completing this period:

Post-intervention (7 months)

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.

6. Primary Endpoint

The registry lists the primary outcome as Proportion of Patients Admitted to the Hospital in Each Group, measured over Within 24 hours of the index EMS encounter.

The primary endpoint asks whether each participant was admitted to the hospital after the index EMS encounter, with the assessment timeframe specified as within 24 hours. The measure is binary: each participant is classified according to whether an admission occurred during that timeframe. The intended group-level summary is the proportion admitted in each study arm.

Hospital admission is used as an outcome representing subsequent care after an EMS encounter. In general, a binary endpoint can provide a direct way to compare the frequency of an event between groups. Its interpretation depends on a clear event definition, a consistent observation window, and complete outcome ascertainment. The registry describes the outcome as whether or not the patient was admitted, but it does not provide further operational details about how admissions were identified or adjudicated.

The endpoint’s timeframe is clinically important to interpretation: the registered question concerns admission within 24 hours, not admission at any later point. The registry does not report the number admitted in either group, the corresponding proportions, or an effect estimate and confidence interval. Therefore, the outcome definition is available, but the primary endpoint result is not reported in the registry record.

The record also lists an asthma impact measure as a secondary outcome. That measure addresses a different dimension from hospital admission, and its results are not reported in the registry record. Neither outcome should be treated as a substitute for the other.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies hospital admission within 24 hours as a binary primary outcome, but does not report an analysis. The concepts below explain how such a comparison is commonly interpreted in general; they do not describe an analysis documented for this study.

What does a binary outcome measure?

A binary outcome classifies each participant into one of two states for the defined observation period. Here, the registered event is hospital admission after the index EMS encounter within 24 hours. A group proportion describes the share of participants who experienced the event among those whose outcomes were assessed. To interpret a proportion, the event count and its denominator must be clear. The registry record does not report the admission counts or proportions for the study arms.

For a comparison between groups, an effect estimate can express how the event frequency differs between the care strategies. Different effect measures answer related but distinct questions. A difference in proportions describes an absolute contrast; a ratio compares event frequencies relative to one another. The registry record does not identify an effect measure or report an estimate, so no such value can be interpreted for this trial.

What does a confidence interval communicate?

In general, a confidence interval describes the uncertainty around an estimated effect under the assumptions of the statistical method. A narrower interval indicates greater precision in the estimate, while a wider interval indicates more uncertainty. The interval does not remove bias from non-random allocation, measurement problems, or incomplete outcome data. Because the registry record reports no effect estimate or interval, the precision of the primary comparison cannot be assessed.

A p-value, when reported, addresses how compatible the observed data are with a specified statistical model and null hypothesis. It is not a measure of the size or clinical importance of an effect, and it does not correct for confounding. No p-value or hypothesis test is reported in the registry record. Statistical significance therefore cannot be assessed from the posted information.

Why does allocation affect interpretation?

In general, random allocation is used to reduce systematic differences between comparison groups. With non-random allocation, the groups can differ in prognosis or care context before the intervention is received. Adjustment for measured characteristics may help address some imbalances, but cannot automatically account for factors that were not measured or not included appropriately. The registry record does not report baseline comparisons, adjustment variables, or an adjusted model. It is not possible to determine whether any such approach was used.

Parallel groups are followed under different care strategies, but the parallel structure alone does not resolve the allocation concern. A valid interpretation would also depend on how the groups were formed, whether outcomes were captured consistently, and whether participants were analyzed according to a prespecified approach. Those details are not reported in the registry record.

What does no masking mean?

The registry lists no masking. In general, masking can reduce the chance that knowledge of the assigned treatment affects care, reporting, or outcome assessment. The possible relevance depends on the outcome. Hospital admission is an observable event, but clinical decisions and their recording may still depend on context. The registry does not describe whether admission decisions were made using common criteria across arms or whether outcome ascertainment was independent of the care team.

How should the pilot description be read?

The study is described as a pilot trial. In general, pilot studies may assess whether a study approach can be implemented and may inform planning for later research. Their results can be uncertain, especially when the primary outcome estimates are not posted. The registry record does not report a sample-size justification or the intended role of the primary outcome in the pilot. It is not possible to infer the study’s design rationale from its enrollment listing alone.

The registry’s general sample-size assumptions describe planning illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such illustrations are planning calculations rather than observed power. They do not constitute the trial’s own design justification, and the registry record does not provide the primary effect needed to evaluate an illustration against the posted trial results. No additional sample-size result can be inferred from the assumptions alone.

What cannot be assessed from the record?

The registry lists 0 analyses and does not report an analysis plan, missing-data approach, analysis population, or adjustment strategy. It also does not report the primary outcome data. Accordingly, readers cannot assess the model used, whether assumptions were checked, whether the analysis followed a prespecified plan, or how missing outcomes were handled. These are general components of evaluating a clinical comparison, not methods that can be attributed to this study without documentation.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Pre-intervention", "Post-intervention")
n      <- c(6, 19)
events <- c(6, 15)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Pre-intervention  6  6  100.0  54.1  100.0  61.0  100.0  59.0  99.6
ARM  Post-intervention  19  15  78.9  54.4  93.9  56.7  91.5  56.3  91.3

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures: hospital admission as the primary outcome and the NIH Patient-Reported Outcomes Measurement Information Systems Asthma Impact Scale as a secondary outcome. It does not report results for either measure in the record available for this analysis. The registry lists 0 analyses and does not describe which outcomes, time points, or comparisons were included in an inferential testing plan.

Multiplicity arises in general when several outcomes, time points, subgroups, or contrasts are tested. Considering many tests can increase the chance that at least one result appears notable by chance. Statistical plans may address this through prespecified priorities or adjustment procedures. The registry record does not report a multiplicity strategy, so it is not possible to determine whether one was planned or used. This is a reporting gap, not evidence that the study did or did not make particular statistical choices.

The registry does not report missing outcome counts, reasons for missingness, or methods for handling missing data. Missingness matters because an analysis based only on participants with recorded outcomes may be biased if outcome availability is related to treatment group or participant characteristics. General methods can address missing data under specific assumptions, but those assumptions and methods cannot be assessed.

The analysis populations are also not reported. The record does not specify whether participants were analyzed according to their assigned care strategy, the care actually received, or another definition. It likewise does not describe exclusions or the handling of protocol deviations. Without these details, the relationship between the enrolled population, the analyzed population, and the registered outcome cannot be evaluated.

These omissions limit assessment of the reliability and reproducibility of any eventual result. They do not establish that analyses or procedures were absent; they indicate that the details are not reported in the registry record.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry reports no serious adverse events in either safety group: 0 among 11 participants at risk in the Continue Current Care group and 0 among 32 participants at risk in the Treatment Bundle and Checklist group. It also reports 0 other events in each group, with the same stated group denominators, and 0 deaths in both groups.

These are the event counts recorded in the registry. A count of zero means no events of the specified category were reported for the listed safety group; it does not establish that the care strategies are free of risk. Safety conclusions depend on how events were defined, collected, monitored, and followed over time. Those details are not reported in the registry record.

The safety figures should not be conflated with the primary endpoint. The primary endpoint is hospital admission within 24 hours, while the adverse-event fields describe serious events, other events, and deaths. The record does not report admission outcome counts, and the safety figures do not provide them. Nor do these counts establish that all possible harms were assessed or that follow-up was complete.

The registry’s listed enrollment is 44, while the safety denominators are reported separately by arm. The record does not explain the relationship between the enrollment listing and the safety groups, so no reconciliation should be inferred from these figures alone.

13. What the Result Does, and Does Not, Mean

The record establishes that the study was completed and describes a non-randomized comparison of existing EMS care with a treatment bundle and checklist. It identifies hospital admission within 24 hours as the primary outcome and lists an asthma impact measure as secondary. It also provides safety event counts for the two groups.

It does not establish whether the bundle was associated with a higher or lower admission frequency. The primary outcome counts, group proportions, effect estimate, confidence interval, and inferential test are not reported in the registry record. Without these results, there is no basis to characterize the direction, size, or precision of the primary comparison. Missing results should not be interpreted as a null finding or as evidence that the groups had the same outcomes.

Even if a difference were reported, the non-randomized design would require caution about causal interpretation. In general, differences between groups may reflect pre-existing participant or site characteristics as well as the care strategy. The record does not report the allocation procedure, baseline comparisons, or statistical adjustment methods needed to evaluate those possibilities.

The reported zero counts for serious events, other events, and deaths are descriptive safety figures. They do not show that no risk exists, and the record does not provide enough information about event ascertainment or follow-up to make a broader safety assessment. The admission endpoint and safety outcomes address different questions.

The study’s pilot designation and completed status are useful context, but neither substitutes for outcome data or a documented statistical analysis. The registry record supports a description of what was intended and how the trial was classified; it does not support a conclusion about effectiveness, clinical benefit, or lack of benefit. The secondary asthma impact result is also not reported.

14. Why This Trial Matters Statistically

This trial addresses a practical statistical problem: comparing care strategies when participants are not randomly allocated. Such studies can evaluate approaches in real care settings, but an observed group difference is harder to interpret because the care groups may also differ in participant characteristics, local practices, or other factors. Clear reporting of allocation, baseline characteristics, outcome ascertainment, and adjusted analyses is therefore important.

The primary endpoint is a concrete binary outcome—hospital admission within a specified period after the EMS encounter. For this outcome to inform readers, the registry record would need to report the event count and denominator for each group, alongside an effect estimate and measure of uncertainty. The record identifies the endpoint but does not report these results. That gap prevents assessment of both the estimated outcome pattern and its precision.

The pilot designation also makes transparent reporting important. Pilot studies can be part of developing and evaluating a research approach, but the record does not report feasibility findings, the study’s statistical plan, or its sample-size rationale. Readers therefore cannot distinguish from the registry information alone whether the intended focus was feasibility, outcome estimation, or another objective beyond the registered summary.

The study is listed as completed, yet the absence of outcome analyses means that completion cannot be equated with a fully interpretable results record. Posting outcome counts, definitions, missing-data information, analysis populations, and methods would allow readers to assess how the evidence was generated. Until those details are available, the study’s statistical contribution is primarily its documented design and outcome framework, not an estimated comparison between care strategies.

15. 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.

Several limitations specific to this record constrain interpretation. The primary endpoint is defined as admission within 24 hours, but the registry does not report admissions by group, group proportions, or an effect estimate. The secondary asthma impact outcome is listed without results. This prevents assessment of either outcome’s observed pattern.

The design is non-randomized, and the registry does not describe how participants entered the two arms. It also does not report baseline characteristics, site-level results, or statistical adjustments. Consequently, the degree of comparability between the care groups cannot be evaluated, and any unreported difference could not be separated from possible baseline or site differences.

No masking is listed, but the record does not explain how outcome ascertainment or admission decisions were standardized. The bundle and checklist are not described in enough detail to assess implementation or fidelity, and the registry does not report whether the listed ipratropium intervention was used in a uniform way across participants or sites.

The registry lists enrollment as 44, while safety denominators are reported as 11 and 32 by group. The record does not explain the relationship between these figures; they should not be reconciled by assumption. It also does not report participant flow, missing outcome counts, reasons for missingness, or analysis populations.

The record identifies 0 analyses and does not report the statistical plan, multiplicity approach, sample-size justification, or handling of missing data. These omissions mean that the appropriateness and completeness of any analysis cannot be assessed. Finally, the reported safety counts lack accompanying details about definitions, collection, and follow-up. The record therefore permits a narrow description of design and recorded counts, but not a complete appraisal of trial conduct or results.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Treating Respiratory Emergencies in Children Study — NCT06074185.
• Registry record last updated 2026-04-24; status last verified 2026-04.
• Results first posted 2026-04-24.
• 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.

19. Record Summary

The registry record describes a completed Phase 2, parallel, non-randomized study with no masking. It lists enrollment as 44 and identifies the study as a three-site pilot trial. The comparison is between continued current EMS care and a treatment bundle with checklist; ipratropium bromide is listed as an intervention.

The primary outcome is hospital admission within 24 hours of the index EMS encounter. An asthma impact measure is listed as secondary. The registry does not report outcome results, an analysis plan, or statistical analyses. It lists 0 analyses.

Safety entries report 0 serious events, 0 other events, and 0 deaths in each group, with denominators of 11 for Continue Current Care and 32 for Treatment Bundle and Checklist. These counts are descriptive and do not establish absence of risk. The record supports understanding the study’s design and registered outcomes, but not estimating the primary treatment-group comparison.