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 Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children (NCT02414399), a randomized phase 4 study. The primary outcome is Re-hospitalization or Death.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02414399 |
| Phase | Phase 4 |
| Condition | Pneumonia, Diarrhea, Malaria |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1400 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Washington |
| Results posted | Yes |
2. Clinical Question
Population
Children aged 1-59 months in Kenya who had been hospitalized with severe illness and were being discharged. The registry describes this as a population at elevated risk of illness and death after discharge. The listed conditions include pneumonia, diarrhea, malaria, co-infection, death, and malnutrition; the record does not say that every child had each condition.
Intervention
Azithromycin at discharge: 10mg/kg for one day, followed by 5mg/kg for four days, for five days of experimental treatment in total.
Comparator
A placebo matched to azithromycin in taste, appearance, and bottle, given for five days.
Primary question
Does azithromycin at discharge, compared with placebo, affect the incidence rate of the composite outcome of death or hospital readmission during the six-month post-discharge follow-up period? The registry also describes secondary questions about growth, re-hospitalizations for specified illnesses, pathogen carriage, antibiotic resistance, and other potential mechanisms. It gives no linked analysis details establishing which of the three listed hazard ratios answers the primary question.
3. Trial Design
The registry describes a randomized, parallel-group trial comparing azithromycin with placebo. Its design fields list randomized allocation, quadruple masking, and a parallel model. The brief description calls the study double-blind and placebo-controlled. These descriptions are not identical, and the registry record does not specify which people were included in the quadruple-masking designation or explain the difference. The study is listed as phase 4.
The record lists enrollment of 1400. The safety information separately identifies the azithromycin group as n=702 and the placebo group as n=696. These are reported values in different parts of the record; the record does not explain their relationship or provide a participant-flow account. The intervention was a five-day azithromycin course, while the comparator was a five-day taste-, appearance-, and bottle-matched placebo.
The primary outcome is described as the incidence rate of a composite of mortality and hospital readmission during six months after discharge. Listed secondary outcomes include length-for-age z-score change, re-hospitalizations for diarrhea, acute respiratory illness, malnutrition, and malaria, carriage of enteric pathogens and Streptococcus pneumoniae, and fecal Escherichia coli isolates resistant to azithromycin. The record also describes investigation of possible mechanisms, resistance among treated children and primary caregivers, and cost-effectiveness.
The sponsor is the University of Washington. The listed start date is 2016-06-28 and the primary completion date is 2020-05-04. The registry status is UNKNOWN. A protocol, detailed analysis plan, and further account of follow-up and participant flow are not reported in the registry record.
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.
Before assignment: Two participants were withdrawn due to ineligibility (1 in the azithromycin arm and 1 in the placebo arm) therefore results are presented among 1398 instead of 1400.
Overall Study
| Stage | Azithromycin (n=702) | Placebo (n=696) |
|---|---|---|
| STARTED | 702 | 696 |
| COMPLETED | 702 | 696 |
| NOT COMPLETED | 0 | 0 |
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 | Azithromycin | Placebo | Total |
|---|---|---|---|---|
| Participants analysed | 702 | 696 | 1398 | |
| Age, Continuous | months | 18 (9 to 31) | 18 (9 to 33) | 18 (9 to 32) |
| Sex: Female, Male: Female | Participants | 276 | 294 | 570 |
| Sex: Female, Male: Male | Participants | 426 | 402 | 828 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 702 | 696 | 1398 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 702 | 696 | 1398 |
| Race (NIH/OMB): White | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Kenya | participants | 702 | 696 | 1398 |
| Recruiting hospital: Kisii Teaching & Referral Hospital | Participants | 412 | 410 | 822 |
| Recruiting hospital: Homa Bay County Referral Hospital | Participants | 259 | 262 | 521 |
| Recruiting hospital: Kendu Adventist Hospital | Participants | 20 | 16 | 36 |
| Recruiting hospital: St Paul Mission Hospital | Participants | 11 | 8 | 19 |
6. Primary Endpoint
The registry lists the primary outcome as Re-hospitalization or Death, measured over 6 months.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | cases per 100 child years |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a composite of re-hospitalization or death, expressed in the registry as cases per 100 child years. The description identifies the outcome as the incidence rate of mortality and hospital readmission over the six-month post-discharge follow-up period. Combining death and readmission gives a single outcome that captures two important kinds of post-discharge events. It also means the composite represents either component, rather than a measure of mortality alone or readmission alone.
As a general statistical point, rates use the amount of time participants are observed as part of their interpretation. This can be useful when follow-up time differs, although the record does not describe the time-at-risk calculation, censoring rules, or how events were handled. A hazard ratio, the form used in the reported Cox regression analyses, compares event hazards over follow-up; it is not itself a rate per 100 child years. The record does not explain how the rate-based endpoint description connects to the listed hazard-ratio analyses.
The registry calls the primary outcome a number and gives its unit as cases per 100 child years, but does not provide a primary outcome event count or rate in the listed results. Nor does it identify which of the three reported hazard ratios corresponds to this endpoint. That missing linkage limits endpoint-specific interpretation of those estimates.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry lists three Cox regression hazard-ratio estimates for the same generic group identifiers, without identifying the outcome or analysis represented by each estimate. The first is HR 0.91, 95% CI .64 to 1.29, p=0.58. The second is HR 0.79, 95% CI 0.39 to 1.58, p=0.49. The third is HR 1.01, 95% CI .70 to 1.47, p=.94. Because the record does not link these estimates to named outcomes, populations, or analysis sets, it is not possible to assign any one of them confidently to the primary composite endpoint.
As a general interpretation, a hazard ratio of 1 represents equal hazards between the groups under the model. An estimate below 1 indicates a lower estimated hazard in the numerator group relative to the denominator group, while an estimate above 1 indicates a higher estimated hazard. The registry does not explicitly map its group identifiers to the treatment names for these analyses, so the direction should not be attributed to azithromycin or placebo without that mapping.
Each listed 95% confidence interval includes 1. Each interval also spans values on either side of 1, so the estimates are compatible with different relative-hazard directions under the fitted model. The p-values are 0.58, 0.49, and .94. These results do not establish a difference by conventional significance testing, but a non-significant result is not proof that the groups are equivalent. The width of the intervals indicates that the estimates remain uncertain; the intervals allow for potentially lower or higher hazards, rather than tightly locating the effect.
These are Cox regression results, not a direct presentation of the composite outcome's event counts or incidence rates. The registry does not provide the number of primary endpoint events by group, baseline characteristics, absolute risks, or an explanation of the analysis populations. It also does not identify whether the three estimates concern the primary endpoint, secondary endpoints, or other analyses. Those omissions prevent a more specific clinical interpretation and make it inappropriate to treat one estimate as the definitive primary result.
The trial used randomized allocation, but the registry also identifies a cluster-randomized design as a reason not to show a simple individual-level recalculation. That design detail matters: observations grouped within clusters may not be statistically independent. The sponsor's own analysis is therefore the relevant analysis available in this record; the displayed estimates should not be supplemented with an individual-level re-analysis that ignores clustering.
9. Statistical Methods Explained
What does a Cox regression estimate?
The registry reports regression analyses using the Cox method and gives hazard ratios. As a general explanation, Cox regression is a time-to-event method. It compares the instantaneous event hazard between groups over follow-up, conditional on the model and its covariates, if any. A hazard is not the same as a cumulative probability of experiencing an event, and a hazard ratio is not a direct difference in event counts or rates. The registry does not report which covariates were included, how time was defined, or how censoring was handled.
The primary outcome description refers to an incidence rate per 100 child years, while the listed analyses use hazard ratios. These measures answer related but distinct questions. The rate expresses events relative to time at risk; the hazard ratio compares modeled event hazards between groups. The registry does not describe the analysis specification connecting its rate-based endpoint definition with the Cox results.
How should a hazard ratio be read?
As a general guide, HR 1 corresponds to no relative difference in hazard under the model. An HR below 1 represents a lower estimated hazard for the numerator group, and an HR above 1 represents a higher estimated hazard. The group labels in the analysis records are generic identifiers, and the registry does not state which is azithromycin or placebo for the reported estimates. The estimates therefore should be read as reported, without assigning a treatment direction that the record does not establish.
A confidence interval describes uncertainty around an estimate under the analysis model. A 95% confidence interval is produced by a procedure that, under its assumptions and repeated use, would cover the true parameter in 95% of such intervals. It is not a statement that the particular interval has a 95% probability of containing the true value. When an interval includes 1 for a hazard ratio, the data do not rule out equal hazards at the corresponding two-sided significance threshold. The listed intervals all include 1 and extend to values on either side of it. This means the estimates are not precise enough to settle the direction of the relative hazard.
What do the p-values add?
A p-value measures how unusual data at least as incompatible with a specified null hypothesis would be if that null hypothesis and the model assumptions were true. It is not the probability that the null hypothesis is true, nor a measure of the size or clinical importance of an effect. The three reported p-values are 0.58, 0.49, and .94. Their interpretation is constrained by the absent mapping between estimates and outcomes, and by the lack of a stated multiplicity plan. They do not establish equivalence or rule out effects that could matter.
Why does clustering matter?
The registry's note says that the study has a cluster-randomized design and that a simple individual-level re-analysis would be misleading. In a cluster-randomized trial, allocation occurs at the group level rather than independently for every individual. People in the same cluster can have correlated outcomes. As a general statistical matter, treating their observations as independent can make standard errors too small and confidence intervals too narrow. Appropriate analysis needs to account for the clustering, through a method consistent with the actual allocation and analysis plan. The record does not identify the cluster units, their number, or the sponsor's specific method for accounting for clustering.
What can be concluded from the analyses listed?
The registry lists three estimates, each with a confidence interval and p-value, but does not name the associated endpoint, analysis population, or comparison direction. No covariate adjustment details, assumptions checks, event counts, or primary-result designation are given for these analyses. They therefore document that Cox regression estimates were reported, but do not provide enough context to reconstruct the model or connect each estimate to a particular clinical question.
The record describes ten outcome measures and six analyses. Multiple outcomes or analyses can create a multiplicity issue: as a general concept, the chance of at least one apparently notable result can increase when many hypotheses are tested. A prespecified hierarchy or adjustment can address this, but no multiplicity plan is reported in the registry record. Missing-data methods and analysis-population definitions are likewise not reported. No sample-size justification, interim-analysis plan, or detailed statistical analysis plan is reported in the registry record.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Regression, Cox | Hazard Ratio (HR) 0.91 | .64 to 1.29 | 0.580 |
| Regression, Cox | Hazard Ratio (HR) 0.79 | 0.39 to 1.58 | 0.490 |
| Regression, Cox | Hazard Ratio (HR) 1.01 | .70 to 1.47 | 0.940 |
The listed estimates are the registry's reported Cox regression results. No independent, unadjusted recalculation is presented. The registry specifically notes that the study is cluster-randomized and that a simple individual-level re-analysis would be misleading, so only the sponsor's own analysis is shown. The sponsor's analysis is therefore the appropriate analysis to describe from this record, rather than an independently recalculated estimate that could fail to account for clustering.
The registry provides no detailed account of the sponsor's model, the cluster adjustment, the covariates used, or the analysis population. It also does not link each of the three hazard ratios to a named outcome or identify which estimate corresponds to the primary composite endpoint. The estimates can be quoted with their confidence intervals and p-values, but their analysis-specific interpretation remains limited by that missing context.
The record does not present a discrepancy between a sponsor analysis and a recalculation. Nor does it include enough detail to evaluate how the sponsor's model was implemented. The absence of an independent recalculation is not evidence of agreement or disagreement; it reflects the stated concern that an individual-level re-analysis would be misleading for this design.
11. Multiplicity, Missing Data and Analysis Populations
The registry lists ten outcome measures and six analyses, including the primary composite and secondary measures of growth, illness-related re-hospitalization, pathogen carriage, and antibiotic resistance. When several outcomes or analyses are examined, chance alone can produce apparently notable results. As a general statistical matter, multiplicity is addressed through prespecified ordering, adjustment, or clearly distinguishing confirmatory from exploratory analyses. The registry record does not report a multiplicity strategy, testing hierarchy, or which analyses were designated confirmatory.
The listed Cox analyses have p-values and confidence intervals, but are not linked to specific outcomes or analysis populations. Without that linkage, the estimates cannot be placed within an outcome-specific testing plan. It is also not reported whether the analyses were prespecified or whether any adjustment for multiple comparisons was applied.
Missing-data methods are not reported in the registry record. There is no description of how missing outcome assessments, incomplete follow-up, or loss to follow-up were handled. The registry also does not identify the analysis populations used for the reported estimates, such as whether analyses followed assigned treatment groups or used another population definition. Participant flow and exclusions are not described in the listed results.
The record does not report an interim-analysis plan, stopping rules, or a sample-size justification. The enrollment value is recorded, but that alone does not explain the assumptions behind the planned sample size or the intended precision for the primary outcome. The registry's note about cluster randomization further emphasizes that the analysis needs to account for the trial's grouping structure; specific details of that adjustment are not reported.
12. 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 |
|---|---|---|---|
| Azithromycin (n=702) | 52 | 702 | 7.4% |
| Placebo (n=696) | 54 | 696 | 7.8% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Azithromycin (n=702) | 15 of 702 |
| Placebo (n=696) | 19 of 696 |
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 |
|---|---|
| Azithromycin (n=702) | 274 of 702 |
| Placebo (n=696) | 276 of 696 |
Most frequent serious adverse event terms
| Event term | Organ system | Azithromycin (n=702) | Placebo (n=696) |
|---|---|---|---|
| Grade 4 or 5 (infections) | Infections and infestations | 43 of 702 | 43 of 696 |
| Grade 4 or 5 (blood and lymphatic system disorders) | Blood and lymphatic system disorders | 13 of 702 | 16 of 696 |
| Grade 4 or 5 (respiratory disorders) | Respiratory, thoracic and mediastinal disorders | 3 of 702 | 3 of 696 |
| Grade 4 or 5 (nervous system disorders) | Nervous system disorders | 1 of 702 | 5 of 696 |
| Grade 4 or 5 (general disorder) | General disorders | 1 of 702 | 2 of 696 |
| Grade 4 or 5 (renal & urinary disorder) | Renal and urinary disorders | 2 of 702 | 1 of 696 |
| Grade 4 or 5 (cardiac disorders) | Cardiac disorders | 1 of 702 | 1 of 696 |
| Grade 4 or 5 (gastrointestinal disorders) | Gastrointestinal disorders | 2 of 702 | 0 of 696 |
| Grade 4 or 5 (injury or poisoning) | Injury, poisoning and procedural complications | 1 of 702 | 1 of 696 |
| Grade 4 or 5 congenital disorders | Congenital, familial and genetic disorders | 0 of 702 | 1 of 696 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Azithromycin (n=702) | Placebo (n=696) |
|---|---|---|---|
| Grade 2 (not reported by system) | General disorders | 193 of 702 | 195 of 696 |
| Grade 1 (not reported by system) | General disorders | 81 of 702 | 81 of 696 |
| Grade 3 (not reported by system) | General disorders | 0 of 702 | 0 of 696 |
Serious events with the highest arm-level rate: grade 4 or 5 (infections) (6.2%), grade 4 or 5 (blood and lymphatic system disorders) (2.3%), grade 4 or 5 (nervous system disorders) (0.7%), grade 4 or 5 (respiratory disorders) (0.4%), grade 4 or 5 (general disorder) (0.3%).
The registry lists serious adverse events for azithromycin (n=702) and placebo (n=696). It reports 52 and 54 participants, respectively, as affected by serious adverse events, and 274 and 276 as affected by other adverse events. Deaths are listed as 15 in the azithromycin group and 19 in the placebo group. These are descriptive counts; the record does not provide confidence intervals, statistical comparisons, or an explanation of how these safety summaries relate to the primary outcome analysis.
The listed serious-event terms include Grade 4 or 5 infections, 6.2%; blood and lymphatic system disorders, 2.3%; nervous system disorders, 0.7%; respiratory disorders, 0.4%; general disorder, 0.3%; and gastrointestinal disorders, 0.3%. These percentages are reported as terms in the registry. The record does not clarify whether categories can overlap, the denominator used for each percentage, or whether the percentages refer to participants or events.
Safety counts should not be treated as adjusted comparisons or as proof of a difference between groups. The record does not give definitions, exposure-adjusted rates, timing, severity breakdowns beyond the listed terms, or methods for evaluating causality. The death counts should also be interpreted with care because death is included in the primary composite outcome, but the registry does not explain how deaths appear across the separate outcome and safety summaries.
13. What the Result Does, and Does Not, Mean
The record describes a randomized comparison of azithromycin with placebo among children discharged after hospitalization with severe illness in Kenya. Its main clinical question concerns the composite of hospital readmission or death during six months after discharge. The reported results include three Cox regression hazard ratios, but the registry does not identify which estimate corresponds to this primary endpoint. The estimates and their uncertainty can be reported, but their clinical meaning cannot be assigned to a specific outcome or treatment direction from the record alone.
For each listed estimate, the 95% confidence interval includes 1, and the reported p-values are 0.58, 0.49, and .94. In general, these features mean the analyses do not provide clear evidence of a relative hazard difference under their models. They do not establish that the treatments are equivalent, and they do not show that a clinically relevant effect is absent. The intervals extend on both sides of 1, leaving uncertainty about the direction and size of the relative hazard.
The registry does not report primary outcome event counts or incidence rates by group, nor does it link the estimates to specific endpoints or analysis populations. It also does not provide enough detail to evaluate the model specification, missing data, multiplicity, or cluster adjustment. Those omissions limit what can be concluded from the posted results. The stated cluster-randomized design means that an individual-level recalculation that ignores clustering is not an appropriate substitute for the sponsor's analysis.
The safety information gives descriptive counts and selected serious-event terms, but not inferential comparisons or enough detail about denominators and event definitions to support a detailed comparative safety assessment. The trial's planned secondary questions about growth, re-hospitalization categories, pathogen carriage, resistance, and cost-effectiveness are described, but the registry information in this record does not provide results for those questions.
Overall, the registry documents the trial question and several reported estimates, while leaving important result-to-outcome and analysis-method links unclear. The record supports describing the estimates as uncertain, not claiming a definitive benefit, harm, or equivalence.
14. Why This Trial Matters Statistically
This trial addresses a statistical problem that arises when studying outcomes after hospital discharge: participants may experience more than one kind of clinically important event, and follow-up takes place over time. The registry's composite outcome combines death and hospital readmission and describes it as an incidence rate over six months. That choice brings two event types into a single primary measure, but makes it important to know how much each component contributes. The registry does not report component-specific primary outcome results.
The design also matters to analysis. The registry identifies cluster randomization and explicitly warns against a simple individual-level re-analysis. This highlights a general principle: the unit of randomization and the dependence structure in the data should be reflected in statistical inference. When people within clusters may have correlated outcomes, methods that ignore that correlation can misstate uncertainty. The available record does not give the specific cluster-adjusted model, so readers cannot fully assess how that issue was handled.
There is a further interpretive lesson in the incomplete linkage between the three hazard ratios and named outcomes. An estimate is not self-explanatory: outcome, comparison direction, analysis population, model, and follow-up all affect its meaning. Confidence intervals and p-values cannot repair missing context. Here, each interval includes 1, while the estimates remain compatible with different relative-hazard directions.
The trial also raises questions beyond the primary endpoint, including growth, specific causes of re-hospitalization, pathogen carriage, antibiotic resistance, and cost-effectiveness. Such a broad set of outcomes makes clear why a transparent analysis plan and an explicit approach to multiple testing are important. Neither is described in the registry record. The case therefore illustrates how design, endpoint definition, analysis structure, and reporting completeness jointly determine what readers can infer from clinical trial statistics.
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 trial-specific limitations of interpretation arise from what the registry reports. Most importantly, the three Cox regression estimates are not linked to named outcomes, and the record does not identify which is the primary endpoint analysis. The group identifiers are also not mapped to azithromycin and placebo in the analysis listing. This prevents a confident treatment-direction interpretation of any individual estimate.
The endpoint is described as an incidence rate of a composite of mortality and hospital readmission, with a unit of cases per 100 child years and a six-month timeframe. The listed results instead give hazard ratios, without event counts, group-specific rates, or details connecting the two measures. Component-specific results for death and readmission are not given in the primary analysis description.
The registry identifies cluster randomization, but does not report cluster units, the number of clusters, or the sponsor's method for accounting for clustering. It notes that a simple individual-level re-analysis would be misleading. The record does not provide model covariates, censoring rules, assumptions checks, analysis populations, or missing-data methods. It also does not report a multiplicity plan, interim analyses, stopping rules, or sample-size justification.
The safety listing gives counts and selected percentages but lacks detail on event definitions, percentage denominators, overlap between categories, and comparative uncertainty. The registry status is UNKNOWN, and the listed record does not provide a participant-flow account or detailed results for the secondary outcomes it names. These are reporting limitations in the registry record; they do not by themselves establish how the trial was conducted or what information may be available elsewhere.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children — NCT02414399.
- Registry record last updated 2023-12-04; status last verified 2023-11.
- Results first posted 2023-12-04.
- 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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19. Record Summary
The registry describes a phase 4, randomized, parallel-group trial of azithromycin versus matched placebo at discharge among Kenyan children aged 1-59 months hospitalized with severe illness. The primary outcome is the composite of re-hospitalization or death during six months of post-discharge follow-up, described as an incidence rate per 100 child years.
Three Cox regression hazard ratios are listed: 0.91, 95% CI .64 to 1.29, p=0.58; 0.79, 95% CI 0.39 to 1.58, p=0.49; and 1.01, 95% CI .70 to 1.47, p=.94. The registry does not link these estimates to specific outcomes or analysis populations. It identifies cluster randomization and states that an individual-level recalculation would be misleading.
Secondary questions include growth, illness-related re-hospitalizations, pathogen carriage, antibiotic resistance, and cost-effectiveness. Safety counts and selected serious-event terms are also listed. Analysis details, missing-data methods, multiplicity procedures, and sample-size justification are not reported in the registry record.