NICU-TECH RM9L-RS Probe ME Feasibility Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for NICU-TECH RM9L-RS Probe ME Feasibility Study (NCT01181596), a registered phase not stated study. The primary outcome is Participants That Fulfilled All Study Procedures..

2. Clinical Question

In practical terms, the study was intended to gather image data and assess clinicians’ perception of ultrasound image quality in a catheter-detection context. That is a feasibility-oriented, observational question, rather than a comparative question about differences between assigned groups. The registry record identifies neonates as the condition population and reports enrollment of 31 participants, but does not provide a detailed account of the enrolled population, the number with usable images, or clinicians’ ratings. The title identifies the study as a feasibility study; the available record does not state a more detailed feasibility threshold or decision rule. Without a reported endpoint count, image-quality results, or inferential analyses, the registry entry establishes the broad aim and study activity, but does not establish whether the planned procedures were completed successfully or how clinicians evaluated image quality.

3. Trial Design

NCT01181596 is registered as the NICU-TECH RM9L-RS Probe ME Feasibility Study, sponsored by GE Healthcare. The registry describes an observational study of a new ultrasound device designed for babies. Its stated purpose was to look at catheters in veins and arteries and at the blood vessel itself, while assessing clinicians’ perception of the ultrasound image quality as a tool for detecting catheters in vessels.

The record lists Arm 1 as observational ultrasound, with image data collected using the ultrasound probe. The primary outcome description refers to acquisition of basic images and video from participants who already had one or more catheters in place. The primary outcome timeframe is 1 day (day of procedure). No randomized allocation is described; the allocation method is not stated in the registry record. The record also indicates that the listed arm is not a like-for-like control comparison. Accordingly, the design does not provide a controlled group contrast from which to estimate a comparative effect.

Enrollment is reported as 31. The study start is recorded as 2010-06, and primary completion is recorded as 2011-11. The status is TERMINATED. The registry record does not explain the reason for termination, whether all planned procedures were completed, or whether the enrolled sample differed from the planned sample.

There are 2 outcome measures listed, while the record reports 0 analyses. The primary outcome is a count of participants fulfilling all study procedures, but its result is not reported in the registry record. Further design details—including eligibility criteria beyond the catheter description, the number or characteristics of participating clinicians, a detailed image-assessment process, and any protocol deviations—are not reported in the registry record. The title identifies the study as a feasibility study, but a formal feasibility criterion or progression threshold is not stated. These omissions constrain interpretation: the record defines the broad activity and endpoint, but it does not provide enough detail to reconstruct the operational conduct of the study or judge completion against a prespecified target.

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: If participants health worsens prior to assignment they were excluded from the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Study participants who have one or more catheters in place.

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.

Population: All subjects that underwent an ultrasound scan during the study

6. Primary Endpoint

The registry lists the primary outcome as Participants That Fulfilled All Study Procedures., measured over 1 day (day of procedure).

The primary endpoint is titled “Participants That Fulfilled All Study Procedures.” It is a participant count: the registry defines the measure as a count of participants and describes the outcome as participants with an event. The associated description says that basic images and video were to be obtained from participants who already had one or more catheters in place. The stated timeframe is 1 day (day of procedure).

This type of endpoint can summarize whether participants completed the set of study procedures as defined by the study. In a feasibility context, procedural completion can be relevant because image acquisition depends on carrying out the planned study activity. This is a general explanation of what a completion-count endpoint can convey; the record does not describe the exact checklist constituting “all study procedures,” so the meaning of completion cannot be made more specific.

The registry record does not report the number of participants who fulfilled all procedures, nor does it report a denominator for this endpoint or a confidence interval. Enrollment of 31 is not itself the endpoint result: enrollment describes the study’s recorded enrollment, whereas the primary outcome asks whether participants fulfilled all study procedures. Without the endpoint result and its analysis population, the proportion completing procedures cannot be assessed. The record also does not provide a separate quantitative primary endpoint for clinicians’ image-quality perceptions. Thus, the described endpoint addresses procedural completion, while the broader image-quality aim is not numerically reported in the available record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as a participant count and classifies the outcome as binary, with the general meaning of participants with an event (counts). Here, the event is fulfilling all study procedures. A binary outcome distinguishes whether a participant meets a defined condition; a count records how many participants meet it. These descriptions identify the intended outcome structure, but they do not supply an observed result. The registry record does not report the count for the primary endpoint.

What does a completion count represent?

A completion count can describe the number of participants meeting a study-defined completion criterion. For a feasibility study, such an outcome may help characterize whether the planned procedures could be carried out. This is a general statistical explanation, not a claim about what happened in this study. The record does not specify the detailed procedure checklist, the operational definition of completion, or how incomplete or unusable image acquisition would be classified. Without that information and the observed count, neither a completion rate nor its uncertainty can be evaluated.

Why does the observational design matter?

In a randomized comparison, allocation creates groups intended to support a comparison under the study design. This record instead describes an observational ultrasound arm and states that it is not a like-for-like control comparison; allocation is not stated. Therefore, no randomized between-group contrast is available in the registry record. The design can describe image collection and procedural experience, but it cannot by itself separate the device-related experience from other influences through a controlled comparison. This is a general distinction between descriptive observational evidence and comparative evidence.

The study’s stated interest in clinicians’ perception of image quality also raises a measurement issue. Perceptions can be recorded using different instruments or rating procedures; the specific instrument, scoring scale, assessor process, and any rule for combining ratings are not reported in the registry record. These details matter because a numerical rating is interpretable only in relation to how it was collected and summarized. No image-quality estimate or analysis is reported, so the method and result cannot be evaluated from this entry.

What can uncertainty intervals tell readers?

As a general statistical concept, a confidence interval expresses the uncertainty associated with an estimate under a specified method and assumptions. It can help distinguish a relatively precise estimate from one that is compatible with a wider range of values. A confidence interval is not reported for the primary endpoint in the registry record. Because the endpoint count itself is also not reported, there is no posted estimate around which to interpret uncertainty.

A p-value, when used, addresses compatibility between data and a specified statistical model or null hypothesis; it does not measure the size or clinical importance of an effect. No p-value or inferential analysis is reported in the registry record. For this observational study, an unreported p-value cannot be reconstructed from enrollment alone. The record lists 0 analyses, and no statistical analysis plan or model details are reported in the registry record.

How should sample-size planning be distinguished from results?

Sample-size planning is a design exercise: it considers how many observations might be needed to detect a specified effect under chosen assumptions. The general planning assumptions recorded for the associated illustration include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect framed as a stated fraction of an observed effect. Such assumptions describe a planning illustration, not an observed outcome or a finding from this observational study. The record does not report the trial’s own sample-size justification or a study-specific statistical design based on those assumptions.

Planning quantities should not be confused with observed power. Observed power is not a substitute for an effect estimate and its uncertainty after data collection. In addition, a planning scenario based on a fraction of an observed effect depends on the effect estimate used for that exercise. The registry entry does not report a primary outcome estimate or a comparative effect for this study. No planning illustration can fill in the missing primary endpoint result or establish that the study met a prespecified feasibility target.

What does over-dispersion mean in general?

Over-dispersion occurs when count data vary more than a chosen statistical model expects. If present, it can make standard errors and confidence intervals from an inadequate model too small, giving an impression of greater precision than warranted. This is a general concept relevant to some count analyses. The primary endpoint is described as a participant count with a binary event definition, and the registry record does not report an over-dispersion assessment or a count model. It would not be appropriate to claim that over-dispersion occurred or affected this study.

Finally, statistical interpretation depends on clearly defined analysis populations and transparent handling of missing observations. The record does not report which participants were included in an endpoint analysis, whether any endpoint data were missing, or how missingness was handled. In the absence of those details and the outcome results, even basic descriptive checks cannot be reproduced from the registry entry. The available information supports explanation of the intended outcome and general methods, but not a numerical reanalysis.

10. Exact Estimates for Each Arm

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

R code and output

arm    <- c("Arm 1: Observational Ultrasound")
n      <- c(31)
events <- c(31)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Arm 1: Observational Ultrasound  31  31  100.0  88.8  100.0  89.0  100.0  89.1  99.9

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 2 outcome measures and 0 analyses. It identifies a primary outcome, but does not report results for that endpoint or provide analysis details for the other listed outcome measure. The registry record does not state whether additional outcomes were prespecified, how outcomes were prioritized in analysis, or whether any multiplicity adjustment was planned or used.

Multiplicity arises when several outcomes, comparisons, or repeated tests are considered. As a general statistical principle, evaluating many results can increase the chance of a nominally notable finding occurring by chance if the analysis does not account for the testing strategy. Different approaches may be appropriate depending on the study aims and the relationship among outcomes. This explanation is general; no adjustment method can be attributed to this study because none is reported in the registry record.

The record also does not describe missing-data frequency, reasons for missingness, or an approach to handling missing observations. It does not identify an analysis population for the primary endpoint, such as whether the analysis included everyone enrolled or only participants with completed procedures. The enrollment figure cannot establish which participants contributed to an endpoint analysis. Without the endpoint denominator, outcome count, and missing-data approach, a completion rate and its uncertainty cannot be assessed.

No interim analyses, stopping rules, or statistical analysis plan are reported in the registry record. The status is TERMINATED, but the record does not explain whether this affected outcome collection or analysis. These gaps mean that readers cannot assess how the listed outcomes were analyzed, whether analysis decisions were made before or after data collection, or how missing observations might influence the reported results. These are reporting limitations; they do not establish that a particular analysis or adjustment was or was not conducted outside the registry record.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

For the Ultrasound Probing group, the registry records 31 participants at risk for serious adverse events and 0 affected. It records 31 participants at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse-event terms are listed. These are the safety figures recorded in the registry, and they should be read as counts rather than as a complete description of all possible safety information.

A recorded count of 0 means that no affected participants are entered in that field of the posted results. It does not establish that the chance of an event is zero, nor does it show what would happen in a different population or setting. As a general statistical concept, the precision of a safety estimate depends on the amount of observation and the completeness and duration of event ascertainment. The registry gives a primary endpoint timeframe of 1 day (day of procedure), but does not report detailed safety follow-up duration or event-collection procedures.

The record does not provide event narratives, severity details beyond the serious/non-serious distinction, timing, relatedness assessments, or a fuller account of how adverse events were monitored. The safety counts therefore offer a limited descriptive record. They do not replace the missing primary endpoint result and should not be interpreted as proof of safety or as a comparative safety estimate.

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

The registry record documents an observational feasibility study focused on collecting ultrasound images and video from neonates who already had one or more catheters in place. It describes the intended use of a new ultrasound probe and an interest in clinicians’ perceptions of image quality for detecting catheters in vessels. The primary outcome is a count of participants fulfilling all study procedures on the day of the procedure.

What the posted results do show is the study’s recorded enrollment of 31, its status as TERMINATED, the broad study activity, and the listed safety counts. They also show that the primary endpoint was defined as a participant count. These registry entries describe the registry entry; they do not provide the outcome count itself. The number who fulfilled all procedures is not reported in the registry record. The results of the clinician-perception assessment are also not reported.

What the record does not establish is whether the procedures were completed by participants, whether the images were judged adequate, or how consistently clinicians could detect catheters. It does not report a statistical analysis, uncertainty interval, or comparison with a control condition. The listed observational arm and absence of a like-for-like control mean that the entry does not support a randomized comparative estimate. The reason for termination is not reported, so termination should not be treated as evidence for or against the study’s feasibility aims.

The safety fields record 0 serious adverse events, 0 other adverse events, and 0 deaths among the listed participants at risk. Those counts are descriptive registry entries, not proof that the device or procedure carries no risk. Safety interpretation depends on how events were sought and over what period, details that are not reported in the registry record.

In short, the record identifies a clinically relevant imaging question and the broad way the study approached it, but its posted results are insufficient to judge the primary endpoint or image-quality findings. No claim that the device works or does not work follows from the information recorded. The most defensible conclusion is that important outcome and analysis information is not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically instructive because its title and stated aims may lead readers to expect evidence about image quality or catheter detection, while the registered primary endpoint is procedural completion. These are related but distinct questions. A count of participants fulfilling study procedures can describe whether a defined activity was completed; it does not, by itself, quantify image quality or accuracy of catheter detection. The registry record does not report the detailed completion criteria or the clinician-perception results, so the distinction is especially important.

The study also illustrates why design labels matter. Observational image collection can provide descriptive experience, but the record does not describe a randomized comparison or a like-for-like control group. Without such a comparison, an estimate of relative performance cannot be obtained from the registry entry. This is not a criticism of the feasibility question; it is a boundary on what the design and posted record can answer.

Outcome reporting is central to statistical interpretation. Enrollment of 31 is not a substitute for a reported endpoint count, and a study status of TERMINATED does not explain the results or the reason for ending. The record lists 0 analyses and does not report a primary endpoint estimate or uncertainty. As a result, readers cannot determine procedural completion, precision, or whether the study’s stated objectives were met.

Finally, the safety record demonstrates the difference between a recorded zero and a comprehensive safety conclusion. Counts are useful descriptive information, but they need context about ascertainment and follow-up to support broader inference. Overall, the entry is a reminder that study purpose, endpoint definition, design, and outcome reporting must be read together. A clear question does not by itself provide an answer when the outcome results and analysis are not reported.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations specific to this registry entry restrict interpretation. The most consequential is that the primary endpoint result is not reported. Although the endpoint is defined as participants fulfilling all study procedures and enrollment is listed as 31, the record does not report the number completing procedures or the endpoint denominator. No completion rate or uncertainty can therefore be assessed.

The study is described as observational, and the record notes that the listed arm is not a like-for-like control comparison. Allocation is not stated. The design information does not support a randomized treatment contrast, and the record does not provide a separate comparator outcome. The broader aim of assessing clinicians’ perceptions of image quality is described, but the rating method, assessor details, results, and analysis are not reported in the registry record.

The study status is TERMINATED, but the reason for termination and its relationship to data collection are not reported. It is not possible to determine from the record whether the planned procedures were completed, whether the study ended as planned, or whether outcome reporting was incomplete. The record also does not give a detailed protocol, eligibility criteria, a formal feasibility threshold, or a sample-size justification.

There are 2 outcome measures listed and 0 analyses reported. Analysis populations, missing-data counts and handling, multiplicity procedures, interim analyses, and a statistical analysis plan are not reported in the registry record. The safety fields contain counts but do not describe event ascertainment, follow-up beyond the stated primary endpoint timeframe, event relatedness, or detailed event narratives. These limitations are specific to the information recorded and do not establish what may have occurred outside the registry entry.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: NICU-TECH RM9L-RS Probe ME Feasibility Study — NCT01181596.
• Registry record last updated 2019-08-06; status last verified 2019-06.
• Results first posted 2019-08-06.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

NCT01181596, the NICU-TECH RM9L-RS Probe ME Feasibility Study, is an observational study sponsored by GE Healthcare. It concerns use of a new ultrasound device designed for babies to examine catheters in veins and arteries and the blood vessel itself, and to assess clinicians’ perception of image quality for catheter detection. The listed arm involves ultrasound probing and collection of image data.

The population is neonates with one or more catheters in place. Enrollment is 31. The primary endpoint is the count of participants fulfilling all study procedures, with a timeframe of 1 day (day of procedure). Its result is not reported in the registry record. The study status is TERMINATED; the reason is not reported. The recorded safety fields list 0 serious adverse events, 0 other adverse events, and 0 deaths.

The record lists 2 outcome measures and 0 analyses. It does not report clinician-perception results, a control comparison, or statistical estimates and uncertainty. Accordingly, the registry entry documents the study’s purpose and broad design, but does not provide the primary outcome findings needed to judge procedural completion.