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 Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial (NCT00878644), a randomized phase 3 study. The primary outcome is Survival With Good Neurobehavioral Outcome.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00878644 |
| Phase | Phase 3 |
| Condition | Cardiac Arrest |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 295 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Michigan |
| Results posted | Yes |
2. Clinical Question
Population
Infants and children who experienced cardiac arrest outside the hospital were the intended study population. The registry describes eligibility for the primary analysis using baseline VABS-II scores or, when that baseline measure was unavailable, specified Pediatric Overall Performance Category and Pediatric Cerebral Overall Performance Category scores. The complete analysis-population description is not reported in the registry record.
Intervention
Participants assigned to the therapeutic hypothermia arm received therapeutic hypothermia after cardiac arrest. The registry summary describes this as lowering and maintaining body temperature below normal for a period of time, but a detailed treatment protocol is not reported in the registry record.
Comparator
Participants assigned to the therapeutic normothermia arm received therapeutic normothermia after cardiac arrest. Detailed treatment procedures for either arm are not reported in the registry record.
Primary question
The primary endpoint asks whether participants were alive at the one-year anniversary of cardiac arrest and had a valid VABS-II score of 70 or greater within the stated assessment window. The posted information does not report a result for this endpoint, so it does not establish the size or direction of the between-arm difference.
The underlying clinical question is whether the two temperature-management approaches differ on a combined outcome that requires both survival and a specified neurobehavioral score. This is more specific than asking about survival alone: a participant must meet both parts of the endpoint to count as having the defined favorable outcome. The registry also lists survival and neurobehavioral measures among the secondary outcomes, but their results are not reported in the registry record.
The study was a randomized, parallel-arm trial. Random assignment is intended to make the groups comparable at the outset, on average, but it does not by itself show that the groups were balanced or that a particular outcome differed. The information describes the trial question and some adverse-event counts, not the primary endpoint comparison. Consequently, the clinical question can be stated, but its answer cannot be determined from the posted results described in the registry record.
3. Trial Design
The trial was a phase 3, randomized, single-masked, parallel-group study sponsored by the University of Michigan. It enrolled 295 participants and is listed as completed. The registry gives a start of 2009-09 and a primary completion of 2014-06. The condition listed is cardiac arrest, and the study focused on cardiac arrest occurring outside the hospital in pediatric patients.
Participants were assigned to therapeutic hypothermia or therapeutic normothermia. The registry identifies the study as randomized, but the method used to generate the assignment sequence, allocation concealment procedures, and allocation ratio are not reported in the registry record. “Single-masked” indicates that masking was reported at one level; which people were masked and how masking was maintained are not reported in the registry record. The trial model is parallel, meaning the two assigned groups were followed as separate arms rather than participants crossing between treatments.
The registry summary describes the study objective as evaluating survival and risk of brain injury. The primary endpoint combines survival at the one-year anniversary of cardiac arrest with a VABS-II score of 70 or greater, measured during a window from 30 days before to 183 days after that anniversary. The registry also lists secondary outcomes concerning survival, change in neurobehavioral function from before cardiac arrest to 12 months afterward, and neuropsychological scores among participants who survived. Results for these secondary outcomes are not reported in the registry record.
The enrollment count is the number recorded as enrolled, not necessarily the number contributing data to every outcome analysis. Arm-specific enrollment for the primary analysis, the number with valid endpoint assessments, and the handling of participants who did not complete assessment are not reported in the registry record. Those details matter because an endpoint requiring survival and a later assessment can have a different available analysis population from the enrolled population.
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 | Therapeutic Hypothermia | Therapeutic Normothermia |
|---|---|---|
| STARTED | 155 | 140 |
| COMPLETED | 151 | 136 |
| NOT COMPLETED | 4 | 4 |
Analysis population for the primary outcome, as defined in the registry: Subjects with baseline VABS-II \>= 70, OR unavailable baseline VABS-II but Pediatric Overall Performance Category (POPC) score and Pediatric Cerebral Overall Performance Category (PCPC) both reflecting none or mild disability (1 or 2), are eligible for the primary analysis. Population is analysis-eligible patients with available primary outcome.
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 | Therapeutic Hypothermia | Therapeutic Normothermia | Total |
|---|---|---|---|---|
| Participants analysed | 155 | 140 | 295 | |
| Age, Continuous | years | 2.1 (0.6 to 10.1) | 1.6 (0.4 to 7.0) | 2.0 (0.5 to 8.7) |
| Age, Customized: Age Category – < 2 yr | Participants | 76 | 73 | 149 |
| Age, Customized: Age Category – 2 - <12 yr | Participants | 48 | 45 | 93 |
| Age, Customized: Age Category – 12 - 17 yr | Participants | 31 | 22 | 53 |
| Sex: Female, Male: Female | Participants | 53 | 46 | 99 |
| Sex: Female, Male: Male | Participants | 102 | 94 | 196 |
6. Primary Endpoint
The registry lists the primary outcome as Survival With Good Neurobehavioral Outcome, measured over Survival was assessed at one-year anniversary of cardiac arrest; among survivors at this one-year anniversary, the VABS-II valid assessment window ranged from 30 days prior to until 183 days after the one-year anniversary date..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is “Survival With Good Neurobehavioral Outcome.” It counts participants who were alive at the one-year anniversary of cardiac arrest and whose standardized VABS-II score was 70 or greater. A valid assessment could occur from 30 days prior to until 183 days after the one-year anniversary. Thus, the endpoint is a binary composite: a participant must satisfy both the survival criterion and the score criterion to be counted as meeting the endpoint.
This kind of endpoint is used to represent more than survival alone. In general, a composite outcome can capture several clinically relevant dimensions in one measure, but its interpretation depends on each component and on the rules for combining them. Here, survival and neurobehavioral status are both essential to the definition. A participant who survived but did not meet the score criterion would not meet the combined endpoint; nor would a participant who did not survive to the specified anniversary.
The registry describes primary-analysis eligibility using baseline VABS-II scores, or specified POPC and PCPC scores when baseline VABS-II was unavailable. The complete population description is not reported in the registry record. The number meeting the primary endpoint, the number analyzed in each arm, and a comparative estimate are also not reported in the registry record. Therefore, the endpoint can be explained from its definition, but the posted information does not establish the frequency or comparative effect for this primary outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The key interpretive limitation is that the posted information does not include a primary-endpoint result. No arm-specific count for “Survival With Good Neurobehavioral Outcome,” between-arm effect estimate, confidence interval, or p-value is reported in the registry record. The trial’s primary clinical question is therefore not numerically answerable from these data. The enrollment count and the descriptions of the treatments and endpoint are not substitutes for an outcome comparison.
The adverse-event information provides a separate descriptive picture. For serious adverse events, the registry lists 153 participants at risk and 98 affected in the therapeutic hypothermia group, and 139 at risk and 102 affected in the therapeutic normothermia group. It also lists other adverse-event counts of 153 at risk and 145 affected in the hypothermia group, and 139 at risk and 124 affected in the normothermia group. These counts describe the posted safety information; they do not supply the missing primary endpoint result. No inferential comparison or uncertainty interval for these adverse-event counts is reported in the registry record.
The registry also lists serious adverse-event terms and percentages, including hypoxic encephalopathy (15.1%), cerebral edema (10.8%), anoxic brain damage (10.1%), hypoxic brain damage (6.5%), cardiac arrest (6.5%), and respiratory infection (3.6%). The available summary does not specify group attribution for these terms, so they should not be read as arm-specific rates. A percentage associated with an event term is not, by itself, a comparative treatment effect.
In general, a confidence interval describes a range of values reasonably compatible with an estimate under the statistical model and analysis used. A p-value addresses how compatible the observed data are with a specified null hypothesis, given the model assumptions; it is not a measure of clinical importance. Neither can be interpreted for the primary endpoint because an estimate and its inferential statistics are not reported in the registry record.
The randomized design is relevant to causal interpretation, but randomization alone cannot replace the missing outcome data or details of the analysis. The registry record does not report the actual primary analysis method, analysis population size, missing-data procedures, or whether the planned analysis was adjusted for any factors. Without those details and the primary comparison, no claim about the direction, magnitude, precision, or statistical significance of the primary outcome is supported by the posted information.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group design. In general, randomization assigns participants to treatment groups through a chance-based process, with the aim of reducing systematic differences between groups at the start of a trial. If randomization is implemented successfully and outcomes are analyzed appropriately, the between-group comparison can support an estimate of the effect of assignment to the study strategies. The registry record does not report the sequence-generation or allocation-concealment methods, so those implementation details cannot be evaluated from the posted information.
Parallel-group trials keep participants in their assigned groups for follow-up rather than switching each participant between strategies. This design suits a comparison in which the study asks about outcomes after assignment to one of two approaches. The registry lists single masking, but does not identify who was masked or explain how masking was maintained. Masking can, in general, reduce the influence of expectations on care, assessment, or reporting, depending on who is unaware of assignment and how the procedures are carried out. The record does not allow those protections to be assessed in detail.
What does the primary endpoint count?
The primary outcome is a binary composite. It classifies each eligible participant according to whether both parts of the endpoint were met: survival at the one-year anniversary and a VABS-II score of 70 or greater within the specified assessment window. For a binary outcome, an arm-level summary commonly reports how many participants meet the definition, alongside the number assessed or included in the analysis. A comparison may then express the difference or ratio between groups, with uncertainty estimates. The registry record does not report those primary-outcome results, so no such comparison can be interpreted.
The endpoint’s assessment window allows a VABS-II assessment from 30 days before to 183 days after the one-year anniversary. In general, a window can accommodate practical variation in assessment timing, but it also makes the exact timing of individual assessments relevant to interpretation. The registry defines the permitted window; the distribution of assessment dates and the number with valid assessments are not reported in the registry record.
Why does the analysis population matter?
The registry describes eligibility for the primary analysis using baseline VABS-II status, or specified POPC and PCPC categories when baseline VABS-II was unavailable. This means the primary endpoint is not described as applying identically to every enrolled participant. In general, an analysis population definition establishes who contributes to a particular estimate and should be considered alongside the outcome definition. The full population description, the number eligible in each arm, and the number included in the analysis are not reported in the registry record. It is therefore not possible to determine how the enrolled population relates numerically to the primary analysis population.
In general, missing outcome data can affect a comparison when participants have no valid endpoint assessment or when missingness is associated with outcomes or treatment assignment. A trial’s analysis plan may use particular rules for participants who die, withdraw, or lack an assessment; those rules can influence what the resulting estimate means. The composite endpoint specifies that survival is required, but the registry information does not give the full missing-data approach or analysis rules. No method should be assumed from the endpoint definition alone.
What can adverse-event counts establish?
Counts of participants affected by adverse events are descriptive. A denominator indicates the number at risk or assessed for the relevant summary, while the affected count indicates how many participants had the event category recorded. In general, the denominator and event definition are essential for interpreting a count. Comparisons also need attention to follow-up duration, repeat events, severity definitions, and whether an individual can contribute to more than one event category. The posted summary does not give all of these details or an inferential comparison for the adverse-event counts.
Over-dispersion is a general issue for count outcomes when observed variability exceeds what a simple count model assumes. It can lead to uncertainty estimates that are too small if ignored. That concept is not itself evidence that over-dispersion occurred in this trial. The primary endpoint is described as a participant count for a binary outcome, and the registry record does not report a model or diagnostic assessment for the trial analysis.
What do the planning assumptions mean?
Any sample-size illustrations associated with the posted results are planning illustrations, not observed trial outcomes and not the trial’s original design justification. The stated illustration assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the effect to detect expressed as a fraction of an observed effect. The registry record does not report the trial’s own sample-size justification or the assumptions used by investigators when designing the trial. Planning figures should not be interpreted as observed power, as evidence that the trial was adequately powered, or as a substitute for the actual endpoint estimate and its precision.
In general, a sample-size calculation describes the amount of information a hypothetical design would need under stated assumptions. Its result depends on the assumed effect, outcome variability, statistical test, allocation, and desired error rates. If the observed effect is used as an input, the illustration is especially dependent on that observed estimate and should be understood as a planning exercise rather than a new clinical finding. No additional sample-size values or primary-outcome effect estimates are reported in the registry record.
Multiplicity refers generally to the increased chance of at least one false-positive finding when many outcomes, comparisons, or analyses are tested without accounting for the number of tests. The registry lists several secondary outcomes, but it does not report a multiplicity strategy or detailed testing hierarchy. That absence does not establish that no strategy was used; it means the approach is not reported in the registry record. The primary result itself is also not reported, so there is no basis for assessing whether its interpretation was affected by multiple testing.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary endpoint and several secondary outcomes: survival, change in neurobehavioral function from before cardiac arrest to 12 months afterward, and neuropsychological scores among participants who survived. The complete results for these outcomes are not reported in the registry record. It also does not report a multiplicity procedure, such as a prespecified hierarchy or adjustment across outcome tests. In general, when multiple hypotheses are examined, the chance of a false-positive finding can increase unless the analysis plan addresses multiplicity. The absence of a reported strategy does not show that the investigators did not use one.
The primary endpoint is defined for an analysis population using baseline VABS-II or specified POPC and PCPC criteria. The complete population description and arm-specific analysis counts are not reported in the registry record. The enrolled total of 295 should not be treated as the number analyzed for every outcome. A comparison’s interpretation depends on knowing who was included and how participants with missing assessments were handled.
The registry gives the endpoint assessment window but does not report the number of participants without a valid VABS-II assessment, the reasons for missing data, or the analysis method used to address missingness. In general, missing-data methods rely on assumptions, and different assumptions can lead to different interpretations. The treatment of deaths and participants who did not complete assessment should follow the endpoint and analysis definitions; those analysis rules are not fully reported in the registry record. Accordingly, the available information is insufficient to assess multiplicity control, missing-data sensitivity, or the extent to which analysis populations differed from enrollment.
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 |
|---|---|---|---|
| Therapeutic Hypothermia | 98 | 153 | 64.1% |
| Therapeutic Normothermia | 102 | 139 | 73.4% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Therapeutic Hypothermia | 92 of 149 |
| Therapeutic Normothermia | 96 of 135 |
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 |
|---|---|
| Therapeutic Hypothermia | 145 of 153 |
| Therapeutic Normothermia | 124 of 139 |
Most frequent serious adverse event terms
| Event term | Organ system | Therapeutic Hypothermia | Therapeutic Normothermia |
|---|---|---|---|
| Hypoxic encephalopathy | Nervous system disorders | 18 of 153 | 21 of 139 |
| Anoxic brain damage | Nervous system disorders | 14 of 153 | 14 of 139 |
| Cerebral edema | Nervous system disorders | 13 of 153 | 15 of 139 |
| Cardiac arrest | Cardiac disorders | 5 of 153 | 9 of 139 |
| Hypoxic brain damage | Nervous system disorders | 10 of 153 | 4 of 139 |
| Brain herniation | Injury, poisoning and procedural complications | 5 of 153 | 5 of 139 |
| Respiratory infection | Infections and infestations | 4 of 153 | 5 of 139 |
| Hypotension | Vascular disorders | 3 of 153 | 4 of 139 |
| Bradycardia | Cardiac disorders | 3 of 153 | 3 of 139 |
| Ischemia | Vascular disorders | 2 of 153 | 4 of 139 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Therapeutic Hypothermia | Therapeutic Normothermia |
|---|---|---|---|
| Hypotension | Vascular disorders | 49 of 153 | 23 of 139 |
| Hypokalemia | Metabolism and nutrition disorders | 35 of 153 | 19 of 139 |
| Anemia | Blood and lymphatic system disorders | 30 of 153 | 18 of 139 |
| Diabetes insipidus | Endocrine disorders | 16 of 153 | 20 of 139 |
| Seizure | Nervous system disorders | 22 of 153 | 14 of 139 |
| Seizures | Nervous system disorders | 20 of 153 | 16 of 139 |
| Hypertension | Vascular disorders | 16 of 153 | 18 of 139 |
| Hyperglycemia | Metabolism and nutrition disorders | 15 of 153 | 16 of 139 |
| Sputum culture positive | Investigations | 16 of 153 | 12 of 139 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 16 of 153 | 11 of 139 |
Serious events with the highest arm-level rate: hypoxic encephalopathy (15.1%), cerebral edema (10.8%), anoxic brain damage (10.1%), hypoxic brain damage (6.5%), cardiac arrest (6.5%).
The registry reports serious adverse-event counts for both arms. In the therapeutic hypothermia group, 153 participants were listed at risk and 98 were affected; in the therapeutic normothermia group, 139 were listed at risk and 102 were affected. For other adverse events, the corresponding counts were 153 at risk and 145 affected in the hypothermia group, and 139 at risk and 124 affected in the normothermia group. These are descriptive counts, not a reported statistical comparison.
The registry also lists deaths: 92 in the therapeutic hypothermia group and 96 in the therapeutic normothermia group. The record does not report an inferential analysis of these counts in the information available for this summary. A count alone does not establish a treatment effect, and the registry’s one-year primary endpoint is not equivalent to a death count because it also requires a neurobehavioral score.
Serious-event terms listed with percentages include hypoxic encephalopathy (15.1%), cerebral edema (10.8%), anoxic brain damage (10.1%), hypoxic brain damage (6.5%), cardiac arrest (6.5%), and respiratory infection (3.6%). These terms are presented without arm-specific attribution in the available summary. In general, adverse-event counts and percentages need clear definitions, denominators, observation periods, and rules for repeat events. Those details and comparative uncertainty estimates are not reported in the registry record, so the figures should be read as descriptive safety information rather than proof of a difference between arms.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized trial compared therapeutic hypothermia with therapeutic normothermia after out-of-hospital pediatric cardiac arrest, and it defines a primary endpoint combining survival at the one-year anniversary with a VABS-II score of 70 or greater. It also reports enrollment, trial-design characteristics, adverse-event counts, deaths, and a list of serious adverse-event terms with percentages.
It does not report the primary endpoint result. Without arm-specific endpoint counts and a comparative estimate, the direction and size of the primary difference are unknown from the posted information. The record also does not report a confidence interval or p-value for that comparison. It is therefore not possible to describe the precision of a primary treatment-effect estimate or to determine whether an inferential test found evidence against a null hypothesis.
The adverse-event figures are not a replacement for the primary result. They provide counts of participants affected and event terms, but do not include a reported inferential comparison or uncertainty intervals. The serious-event percentages are not identified by treatment arm in the available summary. The death counts are also presented without a reported comparative analysis in the information; they should not be treated as a formal estimate of the primary endpoint, which includes neurobehavioral status as well as survival.
In general, a randomized design can support a causal comparison when assignment, follow-up, outcome measurement, and analysis are appropriately implemented. The registry record does not include enough information to assess all of those features, including allocation procedures, masking details, missing-data methods, and the full analysis population. This does not invalidate the trial design; it limits what can be concluded from the record’s posted information.
The appropriate conclusion is narrow: the trial’s question and endpoint are described, but the primary comparison is not reported in the registry record. No claim that either strategy improved or worsened the primary outcome, or that the strategies were equivalent, can be drawn from the information. An absent result is not evidence of no effect, and an adverse-event listing does not determine the result of the primary endpoint.
13. Why This Trial Matters Statistically
This trial illustrates why an endpoint definition and an endpoint result are different kinds of information. The registry specifies a combined outcome that requires survival and a neurobehavioral score within a defined assessment window. That definition tells readers what the investigators intended to count, but it does not reveal how often participants met the definition or how the randomized groups compared.
The composite structure matters statistically because an overall result can reflect more than one component. In general, interpretation of a composite requires knowing how each component contributes and whether component-specific results tell a consistent story. The registry lists survival and neurobehavioral outcomes separately among its secondary outcomes, but their results are not reported in the registry record. Without those findings, neither the primary composite nor its components can be characterized comparatively.
The record also demonstrates the importance of analysis populations and follow-up completeness. A trial enrollment total does not automatically equal the number analyzed for an endpoint requiring a later assessment and defined baseline eligibility. Readers need arm-specific analysis counts and clear missing-data rules to understand what population an estimate represents. Those details are not reported in the registry record.
Finally, safety counts and a primary efficacy endpoint answer different questions. Serious adverse-event counts, deaths, and event-term percentages may be relevant to understanding the trial, but descriptive listings do not replace a prespecified outcome comparison. Statistical interpretation depends on estimates, uncertainty, definitions, denominators, and analysis methods—not on isolated counts alone. Because the primary result and its inferential details are not reported, this record is a useful example of how a detailed design description can coexist with limited evidence for evaluating the trial’s main comparative question.
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 main limitation for interpreting this trial from the registry record is that the primary endpoint result is not reported. There are no arm-specific counts for survival with the specified neurobehavioral outcome, no comparative effect estimate, and no reported uncertainty interval or p-value. The secondary outcomes listed in the record also have no results in the available information. As a result, the main clinical comparison cannot be quantified.
The primary analysis population description is incomplete in the registry record. Although eligibility criteria involving baseline VABS-II or specified POPC and PCPC scores are described, the full population description and the number eligible or analyzed in each arm are not reported. The total enrollment of 295 does not reveal how many participants contributed to the primary endpoint analysis or had a valid assessment.
Important design and analysis details are not reported, including the randomization procedure, allocation concealment, who was masked, treatment-protocol details, the trial’s sample-size justification, the primary statistical method, and the handling of missing outcome data. The registry does not report a multiplicity strategy for the primary and secondary outcomes. These omissions prevent a detailed assessment of the analysis assumptions and robustness.
The safety summary is also limited for comparative interpretation. It presents affected counts, deaths, and serious-event terms with percentages, but the available information does not provide inferential comparisons or uncertainty estimates. The serious-event term percentages are not assigned to treatment arms in the posted summary. Definitions, follow-up details, and rules for repeated events are not fully described. These limits do not establish that the trial was conducted improperly; they define what can and cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Therapeutic Hypothermia to Improve Survival After Cardiac Arrest in Pediatric Patients-THAPCA-OH [Out of Hospital] Trial — NCT00878644.
- Registry record last updated 2017-09-29; status last verified 2017-07.
- Results first posted 2017-09-29.
- 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
The registry record describes NCT00878644, a completed phase 3, randomized, single-masked, parallel-group trial sponsored by the University of Michigan. It enrolled 295 participants, with a start of 2009-09 and primary completion of 2014-06. The trial compared therapeutic hypothermia with therapeutic normothermia after out-of-hospital cardiac arrest in pediatric patients.
The primary endpoint was survival at the one-year anniversary together with a VABS-II score of 70 or greater within the stated assessment window. The registry also lists secondary outcomes involving survival and neurobehavioral or neuropsychological measures. Results for the primary and secondary outcomes are not reported in the registry record. Adverse-event counts, deaths, and serious-event terms are listed, but the available information does not provide inferential comparisons for those figures. The record therefore identifies the trial design and outcome question but does not support a numerical interpretation of the primary treatment comparison.