Time to Accurate Heart Rate on Neonatal Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Time to Accurate Heart Rate on Neonatal Outcomes (NCT04587934), a randomized na study. The primary outcome is Time to Heart Rate Display in iRes Warmer With Resusview.

2. Clinical Question

The clinical question is about the timing of a monitor display, not about a broader measure of newborn health. The registry describes a comparison of the mean time to first displayed heart rate in the period from birth to 10 minutes of life. The monitor result is measured in seconds from birth, and the posted comparison includes newborns with available electrocardiogram data and prenatal consent.

The comparison concerns assignment to two monitoring approaches within iRes Warmer. The ResusView arm uses the experimental electrocardiogram monitor, while the other arm uses an external non-experimental electrocardiogram monitor. Both descriptions place monitoring in routine care and/or neonatal resuscitation. The record does not specify which newborns received resuscitation, how care differed in practice, or whether the result varied according to the circumstances of care.

Consequently, the primary question is a focused operational question: whether the observed average time to display differed between the assigned monitoring approaches in the enrolled population. It does not by itself ask whether either approach changes the timing or quality of subsequent clinical decisions, nor whether it changes neonatal outcomes. Such broader questions are not answered by the primary endpoint reported in the registry.

3. Trial Design

This was a completed, randomized, parallel-group trial with no masking reported. The registry lists enrollment of 42 and identifies Sharp HealthCare as the sponsor. The trial began on 2021-02-01, had primary completion on 2021-06-30, and is recorded as completed. The phase is listed as not applicable.

Participants were assigned to iRes Warmer with ResusView or iRes Warmer without ResusView. The posted primary endpoint groups contain 19 participants in the ResusView arm and 23 in the arm without ResusView. In the first arm, an experimental electrocardiogram monitor was used for heart rate monitoring during the first 10 minutes of life; in the other, an external non-experimental electrocardiogram monitor was used over that period. The record says these approaches were used during routine care and/or neonatal resuscitation.

The registry identifies premature infant, extremely low birth weight, and extreme prematurity as conditions. The brief description frames the intended population as premature newborns at 23 to 32+6 weeks gestation. The exact eligibility criteria beyond the primary endpoint population description are not reported in the registry record. The endpoint population is described as all participants with available electrocardiogram data and prenatal consent.

Random assignment supports a comparison between groups, but important operational details are not reported in the registry record. These include the method used to generate and conceal the allocation sequence, the exact recruitment and exclusion procedures, and whether any departures from assigned monitoring occurred. The record lists seven outcome measures and three posted secondary outcomes. It reports no analysis entries. The protocol's original sample-size rationale and its statistical analysis plan 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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: All with available electrocardiogram data and prenatal consent

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 consented and enrolled in study

6. Primary Endpoint

The registry lists the primary outcome as Time to Heart Rate Display in iRes Warmer With Resusview, measured over Birth to 10 minutes of life.

The primary endpoint is time from birth to the heart rate appearing on the monitor following lead placement. It is expressed in seconds from birth, over the timeframe from birth to 10 minutes of life. The registry reports the mean and standard deviation for each group, and defines the population as participants with available electrocardiogram data and prenatal consent.

This endpoint captures how quickly a displayed heart rate becomes available through the assigned monitoring approach. In this trial, it is a direct timing measure tied to a defined event: the first display after lead placement. It is therefore distinct from a judgment of the accuracy of the displayed rate, the time at which staff act on it, or the eventual health outcome of the newborn. The title refers to accurate heart rate, but the endpoint description specifies time to a heart rate displayed on the monitor; a separate measure of accuracy is not described.

A mean provides a summary of the observed timing across participants, while the standard deviation describes how spread out individual times were around that mean. These summaries can help compare typical timing and variability between the assigned groups, but they do not show every participant's experience or the shape of the distribution. The registry record does not report a median, individual-level timing data, or a separate analysis of whether the monitor displayed a correct rate.

The endpoint is used to address the trial's narrow monitoring-time question. It should not be treated as a surrogate for outcomes that were not measured or as evidence about clinical benefit. The record also does not specify how timing was handled for any participant without a display within the stated timeframe.

7. Results Posted in the Registry

• iRes Warmer Without ResusView: mean 50.00 versus 16.00 on control; difference 34.00 (95% CI 12.98 to 55.02), standardized effect d = 0.90; z-test p = 0.002.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Time to First Change in Fraction of Inspired Oxygen

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • iRes Warmer Without ResusView: mean 175.00 versus 160.00 on control; difference 15.00 (95% CI -55.75 to 85.75), standardized effect d = 0.14; z-test p = 0.678.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between iRes Warmer Without ResusView and the control. The interval gives the range of effects that remain compatible with the data.

Time to First Change in Airway Pressure

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • iRes Warmer Without ResusView: mean 100.00 versus 215.00 on control; difference -115.00 (95% CI -210.96 to -19.04), standardized effect d = -0.79; z-test p = 0.019.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for iRes Warmer Without ResusView than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Time to Initiation of Positive Pressure Ventilation (PPV)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • iRes Warmer Without ResusView: mean 139.00 versus 58.00 on control; difference 81.00 (95% CI 47.23 to 114.77), standardized effect d = 1.34; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for iRes Warmer Without ResusView than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes address related but distinct timing events in the first 10 minutes of life: the first change in fraction of inspired oxygen, the first change in airway pressure, and initiation of positive pressure ventilation. Taken together, the posted estimates do not all point in the same direction. This mixed pattern means the secondary findings do not simply reproduce the primary result across every related measure.

These outcomes can add context to the primary timing measure, but they are not interchangeable with time to first heart rate display. Each concerns a different event, and none directly establishes that the displayed heart rate was accurate or that a particular care action was caused by the monitoring approach. The registry does not report a formal analysis connecting the primary outcome to these secondary outcomes, nor does it describe a pathway linking them.

The posted secondary comparisons are unadjusted, and no multiplicity procedure or prespecified testing hierarchy is reported. When several outcomes are examined, the chance of at least one apparently notable result can increase. This is a general reason to give secondary p-values less weight than a single prespecified primary comparison, especially when their analysis plan and role in the trial's design are not reported.

The registry lists seven outcome measures but posts results for three secondary outcomes, and it reports no analysis entries. The status of other measures, including whether they were collected, analyzed, or omitted from the posted results, is not reported in the registry record. The secondary results are therefore best treated as limited supporting context rather than as a set of confirmatory conclusions. Their differing directions and the absence of reported multiplicity handling make it important not to select one result in isolation or treat the group of outcomes as definitive evidence for a broader effect.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time to First Change in Fraction of Inspired Oxygen
• Time to First Change in Airway Pressure
• Time to Initiation of Positive Pressure Ventilation (PPV)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each participant's result is a time in seconds, and the registry reports group means and standard deviations. A mean difference compares the two group averages. For the primary comparison, the contrast is expressed as the mean for iRes Warmer without ResusView minus the mean for iRes Warmer with ResusView. With that ordering, a positive estimate indicates a larger average time in the group without ResusView. This direction convention matters when reading estimates and confidence intervals.

What does a standard deviation describe?

A standard deviation describes how dispersed participant measurements are around the group mean. It is not the uncertainty in the mean itself, and it is not a range containing all participants. The primary standard deviations are 11.0 seconds in the ResusView group and 50.0 seconds in the group without ResusView. The difference in spread is relevant because the group averages are being compared in a small trial. A mean and standard deviation alone do not show whether the underlying measurements are symmetric, skewed, or affected by extreme values. The individual observations and distributional checks are not reported in the registry record.

How should the mean difference be read?

The posted mean difference is an absolute difference on the original time scale, not a relative or percentage comparison. The estimate of 34.0 seconds summarizes the difference between the posted group means. It does not mean that every participant experienced that difference, and it does not describe how many participants had especially short or long times. The group summaries cannot recover the individual-level pattern.

What does the confidence interval add?

A confidence interval communicates statistical uncertainty around an estimate. In general, an interval is constructed by a method that, under its assumptions, would cover the underlying parameter at the stated confidence level over repeated samples. It is not a guarantee that the true value is inside a particular calculated interval, nor does it describe the range of individual participant values. The primary interval extends from 12.98 to 55.02 seconds for the stated contrast. Its width indicates that the magnitude remains uncertain even though its endpoints are both positive.

The registry does not report the precise model or test used for the primary comparison. It reports no analysis entries, so details such as covariate adjustment, handling of protocol deviations, or distributional diagnostics are not reported in the registry record. The posted comparison is accompanied by an unadjusted p-value of 0.002. A p-value measures how unusual results at least as incompatible with a null comparison would be under a specified statistical model if the null hypothesis were true. It is not the probability that the null hypothesis is true, and it does not quantify the chance that the finding is due to bias or chance in a general sense.

Why can unequal variability matter?

When groups have different degrees of variability, the standard error for a comparison depends on how that variability is represented and on the group sizes. General statistical methods may use a pooled variance under assumptions about similar variability, or may allow group variances to differ. The registry does not identify the exact method used for the reported confidence interval or p-value, so it is not possible to confirm which variance assumptions were applied. The primary group standard deviations differ substantially in the posted summaries, making the analytical choice worth noting rather than assuming.

Over-dispersion is a general concern when observed data vary more than a model expects. It can make model-based uncertainty too narrow if the model does not account for the extra variation. This trial reports means and standard deviations rather than a count outcome model, and no over-dispersion assessment is reported in the registry record. More generally, the distribution of timing values and any unusual observations may affect whether a mean-based summary and its standard error give an adequate account of uncertainty. No individual-level data are available in the registry record to evaluate these issues.

What are the limits of the posted secondary tests?

The secondary endpoints are also reported as continuous timing measures summarized by means and standard deviations. Their posted comparisons include unadjusted p-values, but the registry does not report a multiplicity adjustment, a prespecified hierarchy of testing, or an analysis plan. When several outcomes are examined, interpreting each p-value as though it were the only test can overstate the strength of evidence. The record lists seven outcome measures, while three secondary outcomes have posted results. How the other measures were analyzed or whether they were measured is not reported in the registry record.

General statistical interpretation also separates statistical evidence from practical importance. A small p-value does not itself establish that a difference matters clinically, and an interval does not resolve whether a difference has practical consequences. The registry does not state a clinically important threshold for the primary timing outcome. The statistical result therefore describes the estimated group contrast and its uncertainty, while judgments about clinical importance are not established by the posted analysis.

11. Confidence Intervals and Precision

The primary mean difference is 34.0 seconds for the comparison of iRes Warmer without ResusView against iRes Warmer with ResusView. Its 95% confidence interval runs from 12.98 to 55.02 seconds. Because the interval is entirely positive under this contrast definition, the posted result is consistent with a longer average time in the group without ResusView. The interval also spans a range of possible magnitudes, so the estimate should not be read as an exact or precisely known difference.

Confidence intervals express uncertainty about a group-level quantity, not the range of times experienced by individual newborns. Individual measurements may be more or less dispersed than the interval suggests; the relevant group standard deviations are 11.0 and 50.0 seconds. The trial's group sizes are 19 and 23 for the primary endpoint. In general, limited sample information tends to leave estimates more uncertain, although precision also depends on variability and the analysis method.

The secondary intervals are also informative about precision. For the first change in inspired oxygen fraction, the interval extends from -55.75 to 85.75 seconds. For the first change in airway pressure, it extends from -211.0 to -19.04 seconds. For initiation of positive pressure ventilation, it extends from 47.23 to 114.8 seconds. These intervals are estimates of group mean contrasts, not definitive statements about mechanisms or clinical consequences. The registry does not report adjusted intervals or a method for controlling uncertainty across outcomes.

Interval interpretation depends on the statistical procedure and its assumptions. The exact procedure is not reported in the registry record. In particular, the record does not explain how unequal variability, missing values, or any departures from a statistical model were addressed. The intervals should therefore be read as the uncertainty estimates posted with the comparisons, with those methodological details remaining unclear.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial's original design calculation. They assume a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. The original trial's sample-size assumptions and justification are not reported in the registry record.

For these continuous outcomes, the figures are participants per arm, not a combined total across both arms. The 80% power column means the illustrative number of participants per arm intended to give an 80% chance of detecting the assumed effect under the listed planning assumptions, if that effect and the assumptions are correct. The 90% column represents a higher target chance of detection under the same kind of assumptions and therefore generally calls for more participants per arm. These are planning quantities, not observed outcomes or proof that the trial had a particular chance of finding its result.

The scenarios consider detecting 100%, 75%, or 50% of the observed effect. A smaller effect is harder to distinguish from random variation and therefore requires more participants under a given planning framework. The values should be read as sensitivity illustrations: changing the assumed effect changes the planning requirement, and changing the assumptions could also change it.

This is not observed power. It is not a retrospective measure of the probability that the completed trial detected an effect, and it should not be used to decide whether the observed result is valid. The trial enrolled 42 participants, while the illustrative sample sizes depend on the assumed fraction of the observed effect and on the stated planning assumptions. The figures are not evidence that the original trial was designed around the observed outcome.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 34.000; pooled standard deviation σ = 37.808.
2. n = 2 × (1.96 + 0.842)² × 37.808² / 34.000² = 19.4, rounded up to 20 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 34                      # observed difference in means
sigma <- 37.8080679220719                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4587934)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 20 (80% power), 26 (90% power)
 75% of observed effect: n per arm = 35 (80% power), 47 (90% power)
 50% of observed effect: n per arm = 78 (80% power), 104 (90% power)
power.t.test: 20.4 
Simulated power at n = 20 per arm: 0.791 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when more than one hypothesis or outcome is examined. Even if each individual test uses a conventional significance threshold, running multiple tests can increase the chance that at least one result appears statistically notable by chance. This is a general statistical issue, not a claim about why any particular result occurred in this trial.

The registry lists seven outcome measures and has three secondary outcomes with posted results. It provides unadjusted p-values for the comparisons but does not report a multiplicity adjustment, a hierarchy that would define which outcomes are confirmatory, or a statistical analysis plan. The registry also reports zero analysis entries. Whether multiplicity was addressed in a protocol or other document is not reported in the registry record. Accordingly, the primary result can be read as the posted primary comparison, while the secondary p-values warrant additional caution.

The primary endpoint population is described as all participants with available electrocardiogram data and prenatal consent. This specifies a condition for inclusion in the endpoint population, but the record does not state how many otherwise eligible participants lacked usable data, why data might be unavailable, or how missing values were handled. The primary group sizes are 19 and 23; enrollment is 42. The relationship between enrollment and the analysis set beyond these posted counts is not explained.

The registry does not report whether analysis followed original randomized assignment regardless of monitoring received, whether any participants were excluded after assignment, or how protocol deviations were treated. It also does not report an imputation method or sensitivity analyses for missing data. These details matter because excluding participants or handling incomplete measurements differently can affect comparability and uncertainty.

The description of the primary population and the posted group counts are useful, but they do not substitute for a complete account of analysis populations and missing-data procedures. Details about randomization implementation, prespecified testing, and analysis choices are not reported in the registry record, so the posted estimates cannot be assessed against those aspects of the intended plan.

15. 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.

The registry reports serious adverse events for 0 of 19 participants in the iRes Warmer with ResusView group and 0 of 23 participants in the group without ResusView. Other adverse events are also recorded as 0 in both groups, and deaths are recorded as 0 in both groups. No serious adverse event terms are listed.

These entries describe the events recorded in the registry for the stated at-risk groups. A zero count means that no events in that category were reported for the group; it does not establish that the risk is absent. With relatively small groups, uncommon events may not appear in a trial even if they could occur in a larger population or over a longer observation period.

The registry does not provide further detail about adverse-event definitions, surveillance procedures, severity grading, relatedness assessments, or the duration of safety follow-up. It is therefore not possible to infer from these counts how events were solicited or adjudicated. The safety figures should be interpreted as the posted counts, not as a comprehensive characterization of comparative safety.

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

The primary result shows that, among participants included in the posted endpoint summaries, the mean time to first displayed heart rate was shorter in the iRes Warmer with ResusView group than in the group without ResusView. The estimated mean difference for the specified contrast is 34.0 seconds, and the 95% confidence interval extends from 12.98 to 55.02 seconds. This describes an observed between-group difference in a timing measure.

It does not establish that the monitor displayed a correct heart rate sooner, because the primary endpoint description measures time to display following lead placement and does not define a separate accuracy outcome. It does not establish that staff responded sooner, that care changed, or that neonatal outcomes improved. The registry's secondary measures concern other event timings, but they do not by themselves demonstrate a causal chain from monitoring to health outcomes.

Randomization is a design feature intended to support comparison of assigned groups, but interpretation also depends on how randomization was implemented, the analysis population, missing data, protocol adherence, and statistical methods. These details are not fully reported in the registry record. The modest group sizes and the different standard deviations also mean that the estimated magnitude should be interpreted with its confidence interval, rather than as a fixed value that applies to every participant.

The unadjusted p-value is evidence about compatibility with a null comparison under the test's assumptions; it is not a measure of clinical importance, a probability that the finding is false, or a guarantee of replication. No clinically important difference threshold is reported, and the registry does not provide an original sample-size justification or full analysis plan.

The appropriate scope of interpretation is therefore narrow: the posted data describe group differences in timing outcomes in this completed trial. They do not establish broader effectiveness, comparative safety beyond the recorded counts, or applicability to populations and circumstances not described in the record. The secondary outcomes are not uniformly aligned and carry less evidential weight because they are unadjusted and lack reported multiplicity handling.

17. Why This Trial Matters Statistically

This trial illustrates why a clinical endpoint needs a precise operational definition. The primary measure is not simply whether a monitor was used; it is the elapsed time from birth to the first displayed heart rate following lead placement. That definition makes the endpoint interpretable as a timing outcome, while also clarifying what it cannot answer. It does not directly measure accuracy, response to the display, or health outcomes.

It also illustrates the importance of reading a mean together with its variability and uncertainty. The groups have different reported standard deviations, and the confidence interval for the mean difference spans a range of plausible magnitudes. A p-value alone would not communicate the estimated size or its precision. The interval and the group summaries help place the result in context, although the exact analysis method is not reported.

The contrast between a primary outcome and several secondary outcomes is another useful statistical lesson. Related outcomes can move in different directions, and unadjusted tests across multiple measures should not be interpreted as though only one question had been asked. The registry does not describe a multiplicity plan, reinforcing the need to distinguish the primary comparison from exploratory context.

Finally, sample-size illustrations based on the observed effect are not substitutes for a trial's prospective design rationale. Their assumptions are explicit, but the trial's own original assumptions are not reported. Keeping these concepts separate helps prevent retrospective planning calculations from being mistaken for design evidence or observed power. This record offers a focused example of how design, endpoint definition, precision, multiplicity, and reporting completeness shape statistical interpretation.

18. 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 registry record leaves important details unavailable for evaluating the result. It does not report the randomization sequence method or allocation concealment, and it does not provide the protocol's original sample-size justification or statistical analysis plan. Although the trial is described as randomized and parallel, these omissions limit assessment of how assignment and analysis were implemented.

The primary population is defined by available electrocardiogram data and prenatal consent, but the record does not say how many otherwise eligible participants lacked data or how missing measurements were handled. The group summaries do not include individual observations, medians, or distributional information. The exact method behind the reported confidence interval and p-value is also not stated, despite different group standard deviations.

The primary endpoint measures time to a displayed heart rate, not the accuracy of that rate. The trial description focuses on routine care and/or neonatal resuscitation, but the record does not describe subgroup results by care context or the extent to which participants received resuscitation. It also does not report whether monitoring procedures or other care differed from the stated arm descriptions in practice.

There are three posted secondary outcomes and seven listed outcome measures. The record does not report a multiplicity plan, analyses for the other measures, or an explanation of the absence of analysis entries. The secondary comparisons are unadjusted, so they are less conclusive than a prespecified and appropriately controlled set of tests would be.

The posted safety counts contain no reported events, but definitions and follow-up procedures are not described. The small enrolled groups and limited reporting mean that the safety entries cannot characterize uncommon events. These limitations do not negate the posted timing comparison, but they constrain how broadly and confidently it can be interpreted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Time to Accurate Heart Rate on Neonatal Outcomes — NCT04587934.
• Registry record last updated 2024-01-10; status last verified 2023-12.
• Results first posted 2024-01-10.
• 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.

22. Record Summary

The registry describes NCT04587934, a completed randomized, parallel-group trial sponsored by Sharp HealthCare. It enrolled 42 participants and compared iRes Warmer with ResusView against iRes Warmer without ResusView. Masking is listed as none. The trial began on 2021-02-01 and reached primary completion on 2021-06-30.

The primary outcome was time from birth to heart rate display following lead placement, measured in seconds from birth through 10 minutes of life. The endpoint population is described as participants with available electrocardiogram data and prenatal consent. The posted mean difference favors a shorter average display time in the ResusView group, with a 95% confidence interval from 12.98 to 55.02 seconds for the stated comparison direction.

The registry also posts three secondary timing outcomes and reports no serious adverse events, other adverse events, or deaths in either group. It lists seven outcome measures, reports no analysis entries, and does not report the original sample-size rationale, analysis plan, multiplicity handling, or missing-data procedures. The findings therefore describe the posted comparisons while leaving several details of trial analysis and interpretation unresolved.