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 Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study (NCT02044159), a randomized phase 4 study. The primary outcome is Patient Accrual Rate Over One Year (% of Target Sample Size Achieved).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02044159 |
| Phase | Phase 4 |
| Condition | Shock |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 57 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital of Eastern Ontario |
| Results posted | Yes |
2. Clinical Question
Population
Children with shock who were fluid- and vasoactive infusion-dependent were the intended study population. The registry describes the condition as severe shock and says the study was conducted as a pilot before a larger randomized trial. The primary feasibility objective concerned recruitment across the full study cohort, not a comparison of the enrolled children by treatment arm.
Intervention
Participants randomized to hydrocortisone were to receive an intravenous bolus of 2 mg/kg on enrolment, followed by 1 mg/kg intravenously q6h. Treatment was to continue until there had been no escalation in therapy for at least 12 hours, after which hydrocortisone was to be weaned.
Comparator
The comparator was placebo: normal saline in a volume equivalent to the appropriate hydrocortisone dose. The registry says the placebo and hydrocortisone were intended to be identical in appearance, volume, and smell.
Primary question
The primary endpoint asked whether recruitment over one year reached the study’s accrual target. The protocol goal was 72 patients over one year; recruitment of 60 patients from seven sites in that period was described as adequate. This was a full-cohort feasibility measure, not an endpoint for testing a difference between hydrocortisone and placebo.
3. Trial Design
STRIPES was a randomized, parallel-group pilot study of hydrocortisone versus placebo in children with shock. The registry classifies the study as phase 4 and quadruple-masked. It lists enrollment as 57 and the status as completed. The registry record gives a start date of 2014-07 and a primary completion date of 2016-04.
The pilot was intended to test the study protocol before a larger randomized controlled trial. The registry describes a program examining steroid effectiveness and safety in children, while the pilot’s stated primary objective was feasibility: patient accrual over one year. Its accrual objective applied to the full cohort and, as stated in the protocol description, was not compared between treatment arms.
The planned hydrocortisone regimen began with an intravenous 2 mg/kg bolus on enrolment, followed by 1 mg/kg intravenously q6h until the patient had not had an escalation in therapy for at least 12 hours; the dose was then to be weaned. Placebo was normal saline in a volume equivalent to the relevant hydrocortisone dose. The registry says the preparations were intended to look and smell alike and to have the same volume.
Quadruple masking is the registry’s classification, but it does not identify which specific groups of people were masked. The registry record also does not report the number of sites that actually participated, the allocation ratio, or details of the randomization procedure. Seven sites appear in the stated accrual criterion, not as a confirmed count of sites that enrolled participants.
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 | Hydrocortisone | Placebo |
|---|---|---|
| STARTED | 27 | 30 |
| COMPLETED | 23 | 26 |
| NOT COMPLETED | 4 | 4 |
Reasons for not completing this period:
| Reason | Hydrocortisone | Placebo |
|---|---|---|
| Consent declined (deferred consent) | 2 | 4 |
| No longer eligible, drug not given | 1 | 0 |
| Nurse declined to give study drug | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: This feasibility objective, as stated a priori in the protocol, was analyzed for the full study cohort and was not compared between arms. The primary objective was the patient accrual rate over one year (percentage of for the target sample size for the full cohort that was achieved).
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 | Hydrocortisone | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 23 | 26 | 49 | |
| Age, Continuous | Months | 90.0 (14.3 to 155.8) | 108.0 (44.5 to 146.5) | 92.0 (37.5 to 150.5) |
| Sex: Female, Male: Female | Participants | 11 | 13 | 24 |
| Sex: Female, Male: Male | Participants | 12 | 13 | 25 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Patient Accrual Rate Over One Year (% of Target Sample Size Achieved), measured over 1 year.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of target sample size |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint was patient accrual rate over one year, expressed as the percentage of the target sample size achieved. It measures recruitment feasibility: whether the study could enroll the intended number of participants within the specified recruitment period. Such an endpoint is relevant in a pilot because the ability to recruit is essential to planning a later, larger study.
The registry describes a goal of recruiting 72 patients over one year and says accrual would be considered adequate if 60 patients were recruited from seven sites within that period. These are protocol targets and a feasibility threshold, not observed results. Although the registry lists enrollment as 57, it does not state how many participants were recruited during the one-year accrual period or report the primary endpoint value. The percentage of target achieved is therefore not reported in the registry record.
This endpoint was analyzed for the full study cohort and was not compared between the hydrocortisone and placebo arms. It addresses whether recruitment met a prespecified feasibility objective; it does not measure a treatment effect. The registry record does not report an inferential estimate or confidence interval for the accrual endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The trial’s primary question was about recruitment feasibility, not whether the treatment arms differed on a clinical outcome. The registry specifies an accrual goal of 72 patients over one year and an adequacy criterion of 60 patients recruited from seven sites during that period. These targets clarify what the investigators intended to assess. The registry’s enrollment figure of 57 is not, by itself, a reported one-year accrual result: the record does not say whether that enrollment occurred within the relevant period. It also does not give the percentage of target achieved or state whether the adequacy criterion was met.
The primary endpoint was explicitly assessed in the full cohort and was not compared between study arms. Consequently, an arm-to-arm treatment estimate cannot be inferred from the primary endpoint. The registry lists no analyses, and it does not report a primary endpoint estimate, confidence interval, or p-value. The outcome information available therefore does not establish whether the recruitment objective was achieved.
For safety, the registry reports zero participants with serious adverse events among 23 at risk in the hydrocortisone group and zero among 26 at risk in the placebo group. It also reports other adverse events for 12 of 23 at risk in the hydrocortisone group and 8 of 26 at risk in the placebo group. Deaths are listed for 1 participant in the hydrocortisone group and 3 in the placebo group. These are descriptive counts. The registry does not provide an analysis that attributes events or deaths to study treatment, nor does it report an estimate of the between-group difference or its precision.
A count of zero serious adverse events in each group is a report of what occurred among the participants represented in those rows; it does not demonstrate that serious events are impossible or that the arms have identical safety profiles. Likewise, the other adverse event and death counts should not be read as evidence of a causal treatment effect. Interpretation depends on event definitions, follow-up, completeness of reporting, and the analysis approach, details of which are not reported in the registry record.
Overall, the posted information describes the pilot’s design, recruitment targets, enrollment, and selected safety counts. It does not provide a reported primary accrual result or a formal clinical comparison. The available record therefore supports a description of what was planned and what counts were recorded, but not a conclusion about treatment effectiveness or comparative safety.
9. Statistical Methods Explained
The registry describes a randomized parallel-group study with quadruple masking. Randomization is a method for assigning participants to study groups by chance, which is intended to limit systematic differences between groups at the start of a trial. Masking is intended to reduce the influence of expectations on care, assessment, or reporting. Those are general explanations of the methods; the registry does not report the randomization sequence, allocation concealment procedures, or which people were included in its quadruple-masking classification.
What does the primary endpoint measure?
The endpoint is accrual over one year, expressed as a percentage of the target sample size achieved. In general, a feasibility endpoint asks whether the study procedures, including recruitment, can be carried out as planned. It is not an estimate of how hydrocortisone compares with placebo. The registry identifies a target of 72 patients and a threshold of 60 patients recruited from seven sites within the stated period. It reports enrollment of 57, but does not report recruitment during the one-year window or the endpoint’s calculated percentage. No new percentage can be inferred from the enrollment figure alone because the timing relevant to the endpoint is not stated.
Why is an arm comparison not appropriate for this endpoint?
The record says the accrual objective was analyzed for the full cohort and was not compared between arms. This is coherent with the endpoint’s purpose: it concerns recruitment to the study as a whole. A treatment comparison would instead require an outcome measured in the randomized groups and an analysis designed to estimate a difference between them. The registry lists secondary outcomes that include treatment timing, weaning and discontinuation of study drug, use of open-label steroids, time to discontinuation of vasoactive infusions, adverse events and mortality, and blood-sample processing. The record does not provide results or analyses for those outcomes in the registry record reported.
What do confidence intervals and p-values usually convey?
In general, a confidence interval describes a range of values compatible with the data and the statistical method used. Its width conveys precision: a wider interval indicates greater uncertainty about the estimated quantity. A p-value, when used, measures how unusual data at least as incompatible with a stated null hypothesis would be under that hypothesis and its model assumptions. Neither measure, by itself, establishes clinical importance or causation. The registry record does not report a confidence interval or p-value for the accrual endpoint, and its analysis count is zero.
How should the planning illustrations be read?
The sample-size assumptions describe planning illustrations based on an observed effect, not the trial’s own design. They use a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation; the effect to detect is described as a stated fraction of the observed effect. These are assumptions for illustration rather than evidence that the pilot was designed with those assumptions. A planning sample size is not observed power, and it does not show that an effect is present. The numerical planning estimates and the observed effect to which they refer are not reported in the registry entries summarized for interpretation.
For general context, normal-approximation methods rely on a distributional approximation that may be useful for planning, but the quality of that approximation depends on the outcome and data. If data are more variable than a model assumes, including because observations vary more than expected under a simple count model, uncertainty can be understated unless the method accounts for that extra variation. The registry does not report that such a model was used for the primary endpoint. Its primary outcome is a cohort-level recruitment measure, and no inferential method for it is stated.
What can be concluded from the reported counts?
The serious adverse event, other adverse event, and death values are counts with corresponding group denominators. They describe recorded events; they are not adjusted treatment effects and do not include a reported uncertainty interval or comparative test. General statistical interpretation distinguishes a descriptive count from an estimate of a causal effect. Assessing a treatment contrast would require a defined comparison, appropriate follow-up information, and an analysis plan. Those details and any formal comparative safety analysis are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary feasibility endpoint and secondary outcomes covering several aspects of study-drug administration, vasoactive treatment, adverse events, mortality, and blood-sample processing. When a study examines multiple outcomes, general statistical practice considers multiplicity: the chance of a false-positive finding can increase when many hypotheses are tested. Methods such as prespecifying a primary comparison or adjusting for multiple tests can address that concern, depending on the study’s aims. The registry record does not report a multiplicity strategy, and it lists zero analyses.
The primary objective is described as a full-cohort accrual assessment and explicitly was not compared between arms. The registry does not report an analysis population for the secondary outcomes or a statistical analysis plan describing which participants were included in each analysis. It also does not report how missing outcome data, withdrawals, or incomplete follow-up were handled. These details matter because the interpretation of an estimate depends on who was included and how missing observations were treated.
The record identifies the primary feasibility objective as applying to the full cohort. Safety information is reported by treatment group with group-specific counts at risk, but no further definition of the analysis populations is given. It would be inappropriate to assume that all listed outcomes used the same population or that missing observations were handled in a particular way. The registry does not report imputation, sensitivity analyses, or reasons for missing data.
These omissions limit assessment of how outcomes were selected, how uncertainty was handled, and whether the reported safety counts represent complete follow-up. They do not establish that a particular method was or was not used outside the registry record; the relevant methods are simply not reported in the registry record.
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 |
|---|---|---|---|
| Hydrocortisone | 0 | 23 | 0.0% |
| Placebo | 0 | 26 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Hydrocortisone | 1 of 23 |
| Placebo | 3 of 26 |
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 |
|---|---|
| Hydrocortisone | 12 of 23 |
| Placebo | 8 of 26 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Hydrocortisone | Placebo |
|---|---|---|---|
| New infection | Infections and infestations | 6 of 23 | 5 of 26 |
| Insulin infusion | Endocrine disorders | 4 of 23 | 1 of 26 |
| Gastrointestinal bleeding | Gastrointestinal disorders | 2 of 23 | 2 of 26 |
The registry reports serious adverse events for each treatment group as zero participants affected: 0 among 23 at risk in the hydrocortisone group and 0 among 26 at risk in the placebo group. It separately reports other adverse events for 12 of 23 at risk in the hydrocortisone group and 8 of 26 at risk in the placebo group. Deaths are listed for 1 participant in the hydrocortisone group and 3 in the placebo group.
These are descriptive counts, not estimates of treatment effects. A zero count means that no serious adverse event was recorded in the corresponding group in these data; it does not prove that such an event cannot occur. The record does not give event-level details, timing, follow-up duration, causal assessments, or a statistical comparison. It also does not explain whether the deaths were judged related to treatment. The counts should therefore be read as the safety information recorded in the registry, without interpreting them as evidence that one treatment caused or prevented an event.
12. What the Result Does, and Does Not, Mean
This pilot is important as a study of feasibility in a population the registry describes as children with severe shock. Its primary endpoint focused on whether recruitment could reach a target within one year, as a step before a larger randomized trial. That makes the endpoint relevant to planning and conducting subsequent research, but it is not a clinical treatment-effect outcome.
The registry gives the recruitment goal of 72 patients and describes 60 patients from seven sites within one year as adequate. It also lists enrollment of 57. However, the record does not report how many participants were recruited during the one-year period, the accrual percentage, or whether the stated adequacy threshold was met. The enrollment figure alone cannot answer those questions because the relevant timing is not specified.
The recorded safety counts offer a description of serious adverse events, other adverse events, and deaths in the two groups. They do not provide a formal comparison or establish that the events were caused by study treatment. The registry does not report a comparative estimate, an uncertainty interval, or a significance test for these data. Nor does it report the primary endpoint analysis or analyses of the listed secondary outcomes.
Accordingly, the posted information does not establish whether hydrocortisone differs from placebo on effectiveness or safety. It also does not establish that the recruitment target was achieved. The record documents the trial’s randomized, masked, parallel design, its intended regimen and comparator, the feasibility targets, and selected event counts. Those details are useful for understanding the study’s scope, but they do not substitute for outcome estimates and their precision.
The distinction between a pilot objective and a treatment comparison matters: a feasibility study can inform whether a larger study may be practical without resolving the clinical question. The registry record describes that role for STRIPES, while the reported information does not supply a result that answers a treatment-effect question.
13. Why This Trial Matters Statistically
Clinical trials in critically ill children raise practical and methodological challenges, and the STRIPES pilot was designed to examine whether a larger study protocol could be tested in a smaller group before proceeding to a larger randomized trial. Its focus on recruitment is statistically meaningful: if recruitment targets are not achievable, a later study may need changes to its recruitment approach or design. The registry’s one-year accrual objective and its stated threshold make that feasibility question explicit.
The endpoint also illustrates why outcomes must be interpreted according to their purpose. Patient accrual is a study-level measure, not a comparison of randomized treatments. Treating it as an efficacy outcome would confuse feasibility with clinical effect. The registry explicitly says the primary objective was assessed across the full cohort and was not compared between arms.
The record also distinguishes planned targets from observed data. The accrual goal and adequacy criterion are protocol benchmarks; enrollment of 57 is a separate registry entry. Because the record does not report recruitment within the one-year window or the endpoint value, it cannot establish whether the benchmark was reached. Keeping those quantities distinct prevents a planned threshold from being mistaken for a result.
Finally, the safety counts demonstrate the limits of descriptive data. Counts can communicate what was recorded in each group, but without a stated comparative analysis, event definitions, and information on follow-up and uncertainty, they do not answer whether the groups differed in safety. This is particularly important when a pilot is not presented as a definitive treatment comparison. The statistical value of the study lies in its feasibility aim and the information it was intended to generate for further research; the registry record does not report enough outcome analysis to support conclusions about treatment effects.
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 principal limitation for interpreting the primary objective is that the registry reports enrollment of 57 but does not report the number recruited during the one-year accrual period or the percentage of target achieved. The goal of 72 patients and the adequacy criterion of 60 patients from seven sites are planned benchmarks, not results. The registry record does not state whether the adequacy criterion was met.
The study is identified as a pilot, and its primary endpoint was a full-cohort feasibility measure rather than a between-arm clinical comparison. No primary endpoint analysis is listed, and the registry lists zero analyses. Consequently, the posted information does not provide an estimate or precision measure for the primary endpoint or a formal treatment contrast for clinical outcomes.
The safety information is limited to group-level counts. The registry does not report event descriptions, timing, follow-up duration, attribution to study treatment, comparative analyses, or uncertainty intervals. It also does not report details of missing data, the analysis populations for the secondary outcomes, or how incomplete follow-up was handled. The number of sites that actually enrolled participants is not reported; seven sites occur in the stated adequacy criterion.
Further design details are not reported in the registry record, including the randomization procedure, allocation ratio, the specific parties included in quadruple masking, and the statistical analysis plan. The sample-size assumptions describe planning illustrations rather than the study’s own design. These limitations constrain what can be inferred from the registry record and should not be replaced by assumptions about methods or results that are not reported.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study — NCT02044159.
- Registry record last updated 2019-03-26; status last verified 2019-03.
- Results first posted 2019-03-14.
- 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
STRIPES was a completed phase 4 randomized, parallel-group, quadruple-masked pilot study of hydrocortisone versus placebo in children with shock. The registry lists enrollment as 57, a start date of 2014-07, and a primary completion date of 2016-04.
The primary endpoint was accrual over one year, expressed as a percentage of the target achieved. The stated goal was 72 patients, with 60 patients from seven sites within that period considered adequate. The registry record does not report the accrual endpoint result or a comparison between treatment arms.
Safety entries report zero serious adverse events in each group, other adverse events in 12 of 23 at risk in the hydrocortisone group and 8 of 26 at risk in the placebo group, and deaths of 1 and 3, respectively. These are descriptive counts; the registry does not report a comparative safety analysis. No analyses are listed.