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 Pocket Echocardiography System (PES) for Detection of PDA in Neonates (NCT01790750), a na na study. The primary outcome is False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01790750 |
| Phase | NA |
| Condition | Patent Ductus Arteriosus |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Florida |
| Results posted | Yes |
2. Clinical Question
Population
Neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation were the intended study population. The record describes a single-center feasibility study and lists an enrollment of 50. Parents were to receive a study description; written consent was not requested, and parents could opt out. The registry record does not report further eligibility criteria or a demographic description of enrolled neonates.
Intervention
The intervention was a Pocket echocardiography system scan, or PES, performed before the full-featured echocardiography system scan, or FFES. The PES scan was described as lasting 5 minutes and being used to detect patent ductus arteriosus, or PDA. This is a diagnostic-device evaluation rather than a comparison of assigned therapeutic treatments.
Comparator
The planned comparator was the FFES scan performed after PES. The brief summary also refers to comparison with physical examination alone, but the primary outcome specifically describes false positives in relation to FFES. The registry record does not report a separate physical-examination outcome or explain how the FFES result was defined or adjudicated.
Primary question
The primary question was whether PES could detect PDA in neonates with results comparable to traditional full-featured echo systems, with the primary outcome focused on the percentage of false positives relative to FFES. The posted record does not include the observed percentage, its standard deviation, or an analysis of agreement between the devices. It therefore describes the question and measurement plan, but does not establish how the devices compared in the study.
3. Trial Design
The registry describes a completed, single-center feasibility study of the Pocket echocardiography system (PES) for PDA detection in neonates. The study began in 2013-02 and has a primary completion date of 2013-05. Enrollment is listed as 50. The intervention is labeled “PES first, then FFES,” describing the planned sequence: each patient would receive a 5-minute PES scan followed by a full-featured echocardiography system (FFES) scan, with results compared.
The record identifies the study as single-group and lists allocation as NA and masking as NONE. It is not a randomized, parallel-group treatment comparison. Instead, the study plan places two diagnostic assessments in sequence for the same patient. That structure can support a within-patient comparison if both test results are collected and analyzed in a suitable way; the registry record does not report those individual results or the analysis used. The order is specified, but the record does not say whether order-related effects were evaluated.
The intended population was neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. Parents would be approached and given a study description. Written consent was not to be requested, and parents had the option to opt out. Further eligibility criteria, recruitment details, and the number who opted out are not reported in the registry record.
The University of Florida is listed as sponsor, and the study status is COMPLETED. The record lists phase as NA, which is consistent with a device-feasibility evaluation rather than a drug-phase description. Completion status does not itself indicate that all outcomes were reported. The record lists two outcome measures but no analyses, and the primary outcome result is not reported in the registry record. The stated enrollment and completion status therefore describe the registered study, not the completeness or precision of its diagnostic findings.
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 | PES First, Then FFES |
|---|---|
| STARTED | 50 |
| COMPLETED | 50 |
| NOT COMPLETED | 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 | PES First, Then FFES |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: <=18 years | Participants | 50 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | weeks | 34.8 (SD 4.98) |
| Sex: Female, Male: Female | Participants | 17 |
| Sex: Female, Male: Male | Participants | 33 |
| Region of Enrollment: United States | participants | 50 |
| Body Weight | kg | 2.470 (SD 1.157) |
6. Primary Endpoint
The registry lists the primary outcome as False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES), measured over at baseline.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | percentage of false positives |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is titled “False Positives Results of Pocket Echocardiography System (PES) Detection of Patent Ductus Arteriosus (PDA) to Full Featured Echo System (FFES).” Its unit is a percentage of false positives, its summary measure is a mean, and its dispersion measure is a standard deviation. The timeframe is listed as at baseline. The registry describes the aim as evaluating PES for PDA detection compared with FFES by looking at false positives between the systems.
In general, a false-positive measure is intended to describe positive results from a test that are not supported by the selected comparator or reference assessment. It can be useful in a diagnostic evaluation because it focuses on one kind of disagreement, rather than treating every result as interchangeable. The exact definition matters: the denominator, the rule for calling a result positive, and the handling of unclear results affect the meaning of a percentage. Those details are not reported in the registry record.
The endpoint’s mean and standard deviation would describe the reported distribution if the underlying measurements and analysis were available. Neither the mean nor the standard deviation is reported in the registry record. The listing consequently identifies what investigators intended to measure, but it does not show the observed false-positive result or how precisely that result was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s diagnostic question and its sequence of assessments, but it does not report the primary outcome value. In particular, it gives no observed mean percentage of false positives and no standard deviation for that outcome. Without those results, the posted record does not allow a reader to quantify the frequency of false-positive PES findings, assess variation in the measurement, or compare the observed result with a threshold for an acceptable level of disagreement. No such threshold is reported in the registry record.
The primary outcome is expressed as a percentage and summarized as a mean with standard deviation. Those labels identify the planned form of the result, not the result itself. A mean alone would describe an average, while a standard deviation would describe variation among the measured values; neither would, by itself, show whether a particular individual result was correct. A diagnostic comparison also requires clear definitions of positive and negative findings and an account of how the comparator result was used. Those definitions and the individual-level findings are not reported in the registry record.
The planned sequence—PES followed by FFES—makes the intended comparison clinically focused, but the record lists a single group and no masking. This is not a randomized comparison of separate arms. The fact that both assessments were planned for each patient does not establish that paired data were available, that every enrolled patient completed both scans, or that the analysis accounted for pairing. Those details are not reported in the registry record.
The record lists no analyses. It also lists two outcome measures, but the second outcome’s details and results are not reported in the registry record. The absence of a posted analysis means there is no reported confidence interval, hypothesis test, or other inferential result to interpret. It is not appropriate to infer statistical significance, equivalence, or diagnostic performance from the study title, enrollment, or completed status.
The safety fields list zero affected for serious and other adverse events, with 50 at risk in each field. These are the registry’s recorded counts, not a substitute for the missing diagnostic endpoint. Deaths are recorded as null, so a death count is not reported in the registry record. The safety fields do not answer whether PES detected PDA accurately or how closely it agreed with FFES.
Overall, the record documents a feasibility study plan and selected descriptive registry entries, but not the primary diagnostic result. Statistical interpretation of effectiveness or accuracy is therefore limited to identifying the intended endpoint and explaining what its result would mean if reported. The posted data do not support a numerical estimate of false positives or a conclusion about the comparison.
9. Statistical Methods Explained
Statistical interpretation begins by distinguishing the study question from the evidence recorded as a result. The question concerns the false-positive percentage for PES relative to FFES. The endpoint is described as a continuous measure summarized by a mean and standard deviation. These terms tell readers how the outcome was intended to be represented, but the registry record does not report either value. A named endpoint is not itself an observed finding.
What does a mean and standard deviation describe?
In general, a mean is an average across observations included in an analysis. It can provide a compact description of the center of a distribution, but it does not show whether observations are concentrated near that average or spread across a wide range. A standard deviation describes the spread of observations around the mean. It is not the same as the uncertainty in the estimated mean: the standard error and a confidence interval address uncertainty about an estimate, and require information about the analysis and data.
For this study, the registry labels the endpoint as a mean with standard deviation, but does not report the underlying observations, the mean, or the standard deviation. The registry record also does not specify the denominator used to calculate a false-positive percentage. Without a definition of the percentage and its denominator, the measure cannot be fully reconstructed or compared with another study’s measure. The endpoint timeframe is listed as at baseline, but further measurement details are not reported in the registry record.
Why does the comparison structure matter?
The listed design is single-group, with PES first and FFES second. In general, when two diagnostic assessments are performed on the same participant, their results are naturally paired. A paired analysis can account for the fact that results from one person are related to results from that same person. Treating paired observations as if they came from unrelated groups can misstate uncertainty. The registry record does not report whether all planned paired results were available or how the relationship between the two assessments was handled.
The sequence is relevant as well. In general, fixed ordering can make it difficult to distinguish differences between tests from possible effects associated with the order or timing of assessments. This is a methodological consideration, not evidence that such an effect occurred in this study. The record reports PES followed by FFES, but does not report any evaluation of order-related effects. Masking is listed as NONE. The record does not explain whether image interpretation or outcome determination was performed independently, or how potential knowledge of one result might have affected the other assessment.
What can a confidence interval add?
In general, a confidence interval gives a range of values compatible with the data and the statistical method used, expressing uncertainty around an estimate. A narrow interval indicates greater precision under the assumptions of that method; a wide interval indicates less precision. An interval is not a guarantee that the true value lies within its endpoints, and its interpretation depends on the design, analysis, and data quality.
No confidence interval for the primary endpoint is reported in the registry record. Because the mean and standard deviation are also absent, readers cannot assess the endpoint’s precision from the posted record. Enrollment alone does not supply that information. Precision depends on the observed data and the analysis, not simply on the enrollment figure.
How should planning calculations be read?
In general, a sample-size calculation is a planning exercise that estimates how much information may be needed to detect a specified effect under stated assumptions. The record’s planning assumptions describe two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of an observed effect. These assumptions describe planning illustrations, not the study’s reported design: the registered study is single-group and does not have two randomized arms.
A planning illustration based on an observed effect is not observed power and does not demonstrate that the study did or did not detect an effect. The record does not report the observed primary effect from which such illustrations could be interpreted. It also does not report the trial’s own sample-size justification. Any planning values should therefore be understood as hypothetical design guidance under stated assumptions, not as a result of the completed study or proof of the ability to detect a particular difference.
Why can over-dispersion matter?
In general, over-dispersion means that observed variation is greater than a statistical model assumes. When a model underestimates variation, standard errors may be too small and confidence intervals too narrow. This issue can arise in some types of outcome data, but the registry’s primary endpoint is described as a continuous measure summarized by a mean and standard deviation. The record does not report a fitted model or evidence of over-dispersion, so it is not possible to say whether this issue arose in this study.
More broadly, the useful statistical questions are whether the endpoint was defined clearly, whether the intended paired assessments were available, whether the analysis matched the data structure, and how much uncertainty surrounded the result. The registry record does not report enough outcome or analysis information to answer those questions for the completed study. General statistical concepts explain what a reported analysis could communicate; they cannot fill in the missing result.
10. Confidence Intervals for Each Arm
No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.
| Arm | Participants | Mean | Standard deviation | 95% CI for the mean |
|---|---|---|---|---|
| PES First, Then FFES | 50 | 10.800 | 1.200 | 10.459 to 11.141 |
R code and output
arm <- c("PES First, Then FFES")
n <- c(50)
m <- c(10.8)
sp <- c(1.2)
sd <- sp # posted standard deviations
for (i in seq_along(n)) {
se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}
CARM PES First, Then FFES 50 10.800 1.200 10.459 11.14111. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and no analyses. It identifies the primary measure as the false-positive result for PES compared with FFES, but does not report the second measure’s title, definition, result, or analysis. The registry record does not report whether the outcomes were tested as a family, whether one was designated as secondary, or whether any adjustment for multiple comparisons was planned or used.
In general, evaluating several outcomes can increase the chance that at least one result appears noteworthy by chance if each is interpreted separately. Statistical approaches can address this issue, but the appropriate approach depends on the prespecified questions and analysis plan. No adjustment method or hierarchy of outcomes is reported in the registry record. It is therefore not possible to determine how multiplicity was handled.
Missing-data methods are also not described. The record does not report how incomplete scans, uninterpretable results, missing FFES assessments, or withdrawals would be handled. It does not report the number of participants with usable results for the primary endpoint or whether the analysis included all enrolled participants or a subset. The stated enrollment does not establish that every enrolled participant contributed to each outcome.
The analysis population and any exclusions are not reported in the registry record. Interim analyses, stopping rules, and the statistical analysis plan are not reported in the registry record. These omissions limit assessment of how the outcome was selected, how incomplete observations might affect the result, and whether the posted analysis followed a prespecified plan. Since no analysis results are listed, these uncertainties cannot be resolved by comparing the reported methods with an observed estimate.
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 |
|---|---|---|---|
| PES First, Then FFES | 0 | 50 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| PES First, Then FFES | 0 of 50 |
The registry’s adverse-event fields list the PES First, Then FFES group with 50 at risk and 0 affected for serious adverse events. The separate field for other adverse events also lists 50 at risk and 0 affected. These are the counts recorded in the registry. They describe the entries for this study group; they do not provide a comparison with an untreated or alternative-device group.
The deaths entry is null. A null value is not a reported count of zero, so deaths are not reported in the registry record. The record also does not give event definitions, monitoring procedures, event timing, severity criteria, or an explanation of whether events were judged related to either scan. It is therefore not possible to assess completeness or attribution from the listed counts alone.
In general, a zero recorded count means that no affected participants were entered for that category in the posted record. It should not be read as proof that no event occurred outside the scope of data collection or reporting. These safety entries are distinct from the diagnostic endpoint and do not provide evidence about false positives, agreement, or PDA detection. The record does not report further safety analyses.
13. What the Result Does, and Does Not, Mean
The record establishes that investigators registered a feasibility study of PES for PDA detection in neonates and planned to compare PES findings with a subsequent FFES scan. It also identifies false positives as the primary outcome and describes the intended summary as a mean with standard deviation. Those details explain the question and the measurement approach; they do not show the study’s diagnostic result.
The central result—the observed false-positive percentage—is not reported in the registry record. Nor are its standard deviation, a confidence interval, individual test results, or a statistical comparison. Consequently, the record does not show how often PES produced a false-positive finding, how much results varied, or how precisely the endpoint was estimated. It does not establish that PES and FFES agreed, disagreed, or performed comparably.
This distinction is important because feasibility, measurement, and diagnostic performance are related but different questions. A completed feasibility study can describe a planned procedure and enrollment without reporting enough outcome information to evaluate diagnostic accuracy. In general, a comparison of diagnostic systems requires clearly defined positive findings, a specified comparator, and reported results for the relevant outcome. The registry record does not provide all of these details.
The listed safety counts are separate from the diagnostic question. The record lists zero affected for serious and other adverse events and a null death entry, but these fields do not establish diagnostic performance or provide a full account of safety monitoring. The study’s completed status likewise does not substitute for outcome reporting.
Thus, the posted record supports a description of the study design and its intended primary endpoint, but not a conclusion about the observed false-positive rate or comparative detection results. Any interpretation of effect size, precision, statistical significance, or equivalence would require results that are not reported in the registry record.
14. Why This Trial Matters Statistically
This study raises a useful statistical distinction between evaluating a diagnostic device and comparing assigned treatments. PES was planned before FFES in the same single-group study, so the central comparison concerns diagnostic results rather than outcomes between randomized arms. That distinction affects what an appropriate analysis would need to represent: paired results, definitions of positive findings, and the relationship between each test and its comparator.
The endpoint also illustrates why a label such as “false positives” is not enough to interpret a diagnostic result. In general, a percentage depends on how a positive result is defined and which observations form the denominator. A mean and standard deviation describe a chosen summary and its variability, but neither can resolve ambiguity in an endpoint definition. The registry record does not report the calculation details or the observed values, making those statistical questions especially important.
The study’s feasibility framing should also be kept separate from proof of diagnostic performance. In general, a feasibility evaluation can help establish whether a study procedure can be undertaken, while estimates of test performance require reported outcome data and an account of uncertainty. Here, the record states the planned assessment sequence and enrollment but does not report the primary result. The completed status alone cannot fill that gap.
Finally, the record shows why registry completeness matters to statistical interpretation. A reader can identify the intended endpoint, design, and some safety entries, yet cannot evaluate the primary estimate or its precision without the analysis results. Clear definitions, analysis populations, handling of incomplete results, and reported uncertainty would help distinguish what was planned from what the data demonstrated. These are general principles for interpreting diagnostic studies, not findings about the unreported results of this study.
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.
The main limitation for interpretation is that the primary outcome result is not reported in the registry record. The record provides no false-positive percentage, standard deviation, confidence interval, or other inferential result. It therefore cannot support a numerical assessment of false-positive frequency or precision.
The endpoint description does not define the calculation in enough detail to reproduce it. The registry record does not report the denominator for the percentage, the criteria for a positive PES or FFES finding, or how uncertain or uninterpretable assessments were handled. It also does not report how FFES findings were established or whether readers interpreting either test were independent or masked to other findings.
The study is described as single-center, single-group, and unmasked, with PES followed by FFES. This planned sequence is not a randomized comparison of separate groups. The record does not report whether all participants completed both assessments, whether the paired nature of the observations was accounted for, or whether order-related effects were considered. It also does not report recruitment details, additional eligibility criteria, or the analysis population.
Although the record lists two outcome measures, it does not provide details for the second measure or report analyses. Multiplicity procedures, missing-data methods, interim analyses, and a statistical analysis plan are not reported in the registry record. The trial’s sample-size justification is not reported in the registry record. The listed adverse-event entries provide limited information, and the death count is not reported in the registry record.
These limitations concern what can be learned from the registry record; they do not establish that any particular problem occurred during conduct of the study. The posted information is insufficient to assess the primary diagnostic estimate or the methods used to obtain it.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Pocket Echocardiography System (PES) for Detection of PDA in Neonates — NCT01790750.
- Registry record last updated 2014-04-11; status last verified 2014-03.
- Results first posted 2014-04-11.
- 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 record describes NCT01790750, “Pocket Echocardiography System (PES) for Detection of PDA in Neonates,” sponsored by the University of Florida. It lists the study as COMPLETED, single-center, single-group, and nonrandomized, with masking listed as NONE. Enrollment is 50; the start is recorded as 2013-02 and primary completion as 2013-05.
The planned sequence was a 5-minute PES scan followed by FFES for neonates admitted to the neonatal intensive care unit with orders for a cardiac echo evaluation. The primary outcome concerns the percentage of false positives for PES relative to FFES, summarized as a mean with standard deviation. The primary result and its precision are not reported in the registry record. The record lists two outcome measures and no analyses.
For safety, the posted fields list 0 affected for serious and other adverse events, with 50 at risk in each field. The deaths entry is null, so a death count is not reported in the registry record. The available record describes the intended study and selected registry entries but does not provide the diagnostic outcome findings needed to judge the comparison.